Search results for: randomized controlled trial

Authors: J. Punj, R. K. Pandey, V. Darlong, K. Thangavel

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Background: Dural puncture epidural (DPE) technique has been introduced recently for labour analgesia however, no study has compared ropivacaine and levobupivacaine for the same. Methods: The primary aim of the study was to compare time to onset of the Numerical Pain Rating Score (NPRS) ≤ 1 in labour analgesia with both drugs. After obtaining ethics and patient consent, ASA I and ASA II parturient with single foetus in vertex presentation and cervical dilatation <5.0 cm were included. DPE was performed with 16/ 26 G combined spinal epidural (CSE) technique, and parturients randomized into two groups. In Group R ( Ropivacaine) 20 ml 0.125% ropivacaine+ fentanyl 2µg/ml was injected to a maximum of 20 ml in 20 minutes and in Group L (Levobupivacaine), 20 ml 0.125% levobupivacaine + fentanyl 2µg/ml was injected. Outcomes were assessed at 0.5,2,4,6,8,10,12,14,16,18,20 and 30 minutes, then every 90 minutes until delivery. Appropriate statistical analysis was done, and p value of <0.05 was considered statistically significant. Results: The median time to onset of NPRS ≤1 in both groups was comparable (group R= 16 minutes vs group L= 18 minutes (p = 0.076). Volume of drug for NPR ≤1 in both groups was also comparable (Group R 15.95± 2.03 ml vs Group L 16.35 ± 1.34 ml (p=0.47). Conclusion: DPE with 16 G epidural needle and 26 gauge spinal needle with both 0.125% ropivacaine and 0.125% levobupivacaine results in similar efficacy of labour analgesia.

Keywords: dural puncture epidural, labour analgesia, obstetric analgesia, hypotension

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Authors: Arslan Shehroz, Muhammad Amjad Ali, Amjad Abbas, Imran Ramzan, Muhammad Zunair Latif

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Potato (Solanum tuberosum L.) is the 4th most important food crop of the world after wheat, rice and maize. It is the staple food in many European countries. Being rich in starch (one of the main three food ingredients) and having the highest productivity per unit area, has great potential to address the challenge of the food security. Processed potato is also used as chips and crisps etc as ‘fast food’. There are many biotic and abiotic factors which check the production of potato and become hurdle in achievement production potential of potato. 20 new varieties along with two checks were evaluated. Plant to plant and row to row distances were maintained as 20 cm and 75 cm, respectively. The trial was conducted according to the randomized complete block design with three replications. Normal agronomic and plant protection measures were carried out in the crop. It is revealed from the experiment that exotic variety 171 gave the highest yield of 35.5 t/ha followed by Masai with 31.0 t/ha tuber yield. The check variety Simply Red 24.2 t/ha yield, while the lowest tuber yield (1.5 t/ha) was produced by the exotic variety KWS-06-125. The maximum emergence was shown by the Variety Red Sun (89.7 %). The lowest emergence was shown by the variety Camel (71.7%). Regarding tuber grades, it was noted that the maximum Ration size tubers were produced by the exotic variety Compass (3.7%), whereas 11 varieties did not produce ration size tubers at all. The variety Red Sun produced lowest percentage of small size tubers (12.7%) whereas maximum small size tubers (93.0%) were produced by the variety Jitka. Regarding disease infestation, it was noted that the maximum scab incidence (4.0%) was recorded on the variety Masai, maximum rhizoctonia attack (60.0%) was recorded on the variety Camel and maximum tuber cracking (0.7%) was noted on the variety Vendulla.

Keywords: check variety, potato, potential and yield, trial

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Authors: Todd Jackson

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In this randomized control trial, we tested the effectiveness of a peer-facilitated version of the Body Project (BP) intervention among body-dissatisfied young women in China. Participants were randomly assigned to a peer-facilitator BP condition (N = 94) versus an educational video minimal intervention control condition (N = 89). Questionnaire measures of two primary outcomes (i.e., disordered eating and body dissatisfaction) and six secondary outcomes (thin-ideal internalization, pressure to be thin, negative affect, body surveillance, body shame, body appreciation and interest in cosmetic surgery) were administered at a pre-treatment baseline, a post-treatment assessment, and at a 12-month follow-up. A series of 2 (Group) x 2 (Time) analyses of variance indicated women in the peer-facilitated BP condition reported significant improvements in primary outcome measures of disordered eating and body dissatisfaction compared to women in the educational video control condition following treatment and at the 12-month follow-up. Furthermore, women in the peer-facilitated BP condition reported significant improvements in measures of body surveillance, body shame and body appreciation) compared to educational video controls that extended to the 12-month follow-up. Finally, although women in the peer-facilitated BP condition showed significant post-treatment improvements in thin-ideal internalization, negative affect, perceived pressure to be thin, and interest in cosmetic surgery compared to video controls, these differences were no longer statistically significant at the 12-month follow-up. In conclusion, findings supported the overall effectiveness of a peer-facilitated group version of the BP as an intervention for reducing disordered eating and several associated risk factors among at-risk young women in China.

Keywords: body project, disordered eating, body dissatisfaction, risk factors, prevention, China

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Authors: Camila Lemos Pinto, Juliana Alves Carneiro, Patrícia Borges Botelho, João Felipe Mota

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Sarcopenia, a syndrome characterized by progressive and generalized loss of skeletal muscle mass and strength, currently affects over 50 million people and increases the risk of adverse outcomes such as physical disability, poor quality of life and death. The aim of this study was to examine the efficacy of creatine supplementation associated with resistance training on muscle mass in the elderly. A 12-week, double blind, randomized, parallel group, placebo controlled trial was conducted. Participants were randomly allocated into one of the following groups: placebo with resistance training (PL+RT, n=14) and creatine supplementation with resistance training (CR + RT, n=13). The subjects from CR+RT group received 5 g/day of creatine monohydrate and the subjects from the PL+RT group were given the same dose of maltodextrin. Participants were instructed to ingest the supplement on non-training days immediately after lunch and on training days immediately after resistance training sessions dissolved in a beverage comprising 100 g of maltodextrin lemon flavored. Participants of both groups undertook a supervised exercise training program for 12 weeks (3 times per week). The subjects were assessed at baseline and after 12 weeks. The primary outcome was muscle mass, assessed by dual energy X-ray absorptiometry (DXA). The secondary outcome included diagnose participants with one of the three stages of sarcopenia (presarcopenia, sarcopenia and severe sarcopenia) by skeletal muscle mass index (SMI), handgrip strength and gait speed. CR+RT group had a significant increase in SMI and muscle (p<0.0001), a significant decrease in android and gynoid fat (p = 0.028 and p=0.035, respectively) and a tendency of decreasing in body fat (p=0.053) after the intervention. PL+RT only had a significant increase in SMI (p=0.007). The main finding of this clinical trial indicated that creatine supplementation combined with resistance training was capable of increasing muscle mass in our elderly cohort (p=0.02). In addition, the number of subjects diagnosed with one of the three stages of sarcopenia at baseline decreased in the creatine supplemented group in comparison with the placebo group (CR+RT, n=-3; PL+RT, n=0). In summary, 12 weeks of creatine supplementation associated with resistance training resulted in increases in muscle mass. This is the first research with elderly of both sexes that show the same increase in muscle mass with a minor quantity of creatine supplementation in a short period. Future long-term research should investigate the effects of these interventions in sarcopenic elderly.

Keywords: creatine, dietetic supplement, elderly, resistance training

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Authors: Vu Hoang Thu Huong

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Background and Purpose: The effects of Extracorporeal Shockwave Therapy (ESWT) in the participants with knee osteoarthritis (KOA) were unclear on physical performance although its effects on pain had been investiagted. This study aims to explore the effects of ESWT on pain relief and physical performance on KOA. Methods: The studies with the randomized controlled design to investigate the effects of ESWT on KOA were systematically searched using inclusion and exclusion criteria through seven electronic databases including Pubmed etc. between 1990 and Dec 2022. To summarize those data, visual analog scale (VAS) or pain scores were determined for measure of pain intensity. Range of knee motion, or the scores of physical activities including Lequesne index (LI), Knee Injury and Osteoarthritis Outcome Score (KOOS), and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) were determined for measure of physical performances. The first evaluate after treatment period was define as the effect of post-treatment period or immediately effect; and the last evaluate was defined as the effect of following period or the end effect in our study. Data analysis was performed using RevMan 5.4.1 software. A significant level was set at p<0.05. Results: Eight studies (number of participant= 499) reporting the ESWT effects on mild-to-moderate severity (Grades I to III Kellgren–Lawrence) of KOA were qualified for meta-analysis. Compared with sham or placebo group, the ESWT group had a significant decrease of VAS rest score (0.90[0.12~1.67] as mean difference [95% confidence interval]) and pain score WOMAC (2.49[1.22~3.76]), and a significant improvement of physical performance with a decrease of the scores of WOMAC activities (8.18[3.97~12.39]), LI (3.47[1.68~5.26]), and KOOS (5.87[1.73~ 10.00]) in the post-treatment period. There were also a significant decrease of WOMAC pain score (2.83[2.12~3.53]) and a significant decrease of the scores of WOMAC activities (9.47[7.65~11.28]) and LI (4.12[2.34 to 5.89]) in the following period. Besides, compared with other treatment groups, ESWT also displayed the improvement in pain and physical performance, but it is not significant. Conclusions: The ESWT was effective and valuable method in pain relief as well as in improving physical activities in the participants with mild-to-moderate KOA. Clinical Relevance: There are the effects of ESWT on pain relief and the improvement of physical performance in the with KOA.

Keywords: knee osteoarthritis, extracorporeal shockwave therapy, pain relief, physical performance, shockwave

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Authors: Mark Linden, Rachel Leonard, Trisha Forbes, Michael Brown, Lynne Marsh, Stuart Todd, Nathan Hughes, Maria Truesdale

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Background: Current interventions which aim to improve the mental health of family carers are often face to face, which can create barriers to full participation. Online interventions can offer flexibility in delivery compared to face to face approaches. The primary objective of this study is to determine the feasibility of delivering the Carers-ID online intervention, while the secondary outcome is to improve the mental health of family carers of people with intellectual disabilities. Methods: Family carers (n = 120) will be randomised to receive the intervention (n=60) or assigned to a wait-list control (n=60) group. The intervention (www.Carers-ID.com) consists of fourteen modules which cover topics including promoting resilience, providing peer support, reducing anxiety, managing stress, accessing local supports, managing family conflict and information for siblings who are carers. Primary outcomes for this study include acceptability and feasibility of the outcome measures, recruitment, participation and retention rates and effect sizes. Secondary outcomes will be completed at three time points (baseline, following intervention completion and three months after completion). Secondary outcomes include, depression, anxiety, stress, well-being , resilience and social connectedness. Participants (n=12) who have taken part in the intervention arm of the research will be invited to participate in semi-structured interviews as part of the process evaluation. Discussion: To determine whether a full-scale randomised controlled effectiveness trial is warranted, feasibility testing of the intervention and trial procedures is a necessary first step. The Carers-ID intervention provides an accessible resource for family carers to support their mental health and well-being.

Keywords: intellectual disability, family carer, feasibility trial, online intervention

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Authors: Sumrina Kousar

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Objective: The aim of this study was to observe the effect of fortification of expressed human breast milk with olive oil and skimmed milk in improving weight gain in very low birth weight neonates and shortening their length of hospital stay. Study Design and place: A randomized controlled trial was carried out at the Combined Military Hospital Lahore from March 2018 to March 2019. Methods: Neonates admitted with very low birth weight and gestational age of < 34 weeks were included in the study. Sixty babies were enrolled using non-probability consecutive sampling; a random number table was used to allocate them into a fortification group and a control group. The control group received expressed milk alone, while olive oil 1 ml twice daily and skimmed milk 1 gram in every third feed were added to expressed milk in the fortification group. Data was analyzed on SPSS 20. Proportions were compared by applying the chi-square test. An independent sample t-test was applied for comparing means. A p-value of ≤ 0.05 was considered significant. Results: The study comprised of 60 neonates, with 30 in each of the groups. Weight gain was 24.83±5.63 in the fortification group and 11.72±3.95 in the control group (p =< 0.001). Mean hospital stay was 20.5716.511 in the fortification group and 27.678.89 in the control group (p =< 0.043). Conclusion: Olive oil and skimmed milk fortification of breast milk was effective for weight gain and reducing the length of hospital stay in very low birth weight neonates.

Keywords: fortification, olive oil, skimmed milk, weight gain

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Authors: Johnson C. Y. Pang, Bo Pengb, Kara K. L. Reevesc, Allan C. L. Fud

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Objective: Dry needling (DN) has long been used as a treatment method for various musculoskeletal pain conditions. However, the evidence level of the studies was low due to the limitations of the methodology. Lack of randomization and inappropriate blinding are potentially the main sources of bias. A method that can differentiate clinical results due to the targeted experimental procedure from its placebo effect is needed to enhance the validity of the trial. Therefore, this study aimed to validate the method as a placebo ultrasound(US)-guided DN for patients with knee osteoarthritis (KOA). Design: This is a randomized controlled trial (RCT). Ninety subjects (25 males and 65 females) aged between 51 and 80 (61.26±5.57) with radiological KOA were recruited and randomly assigned into three groups with a computer program. Group 1 (G1) received real US-guided DN, Group 2 (G2) received placebo US-guided DN, and Group 3 (G3) was the control group. Both G1 and G2 subjects received the same procedure of US-guided DN, except the US monitor was turned off in G2, blinding the G2 subjects to the incorporation of faux US guidance. This arrangement created the placebo effect intended to permit comparison of their results to those who received actual US-guided DN. Outcome measures, including the visual analog scale (VAS) and Knee injury and Osteoarthritis Outcome Score (KOOS) subscales of pain, symptoms and quality of life (QOL), were analyzed by repeated-measures analysis of covariance (ANCOVA) for time effects and group effects. The data regarding the perception of receiving real US-guided DN or placebo US-guided DN were analyzed by the chi-squared test. The missing data were analyzed with the intention-to-treat (ITT) approach if more than 5% of the data were missing. Results: The placebo US-guided DN (G2) subjects had the same perceptions as the use of real US guidance in the advancement of DN (p<0.128). G1 had significantly higher pain reduction (VAS and KOOS-pain) than G2 and G3 at 8 weeks (both p<0.05) only. There was no significant difference between G2 and G3 at 8 weeks (both p>0.05). Conclusion: The method with the US monitor turned off during the application of DN is credible for blinding the participants and allowing researchers to incorporate faux US guidance. The validated placebo US-guided DN technique can aid in investigations of the effects of US-guided DN with short-term effects of pain reduction for patients with KOA. Acknowledgment: This work was supported by the Caritas Institute of Higher Education [grant number IDG200101].

Keywords: reliability, jumping, 3D motion analysis, anterior crucial ligament reconstruction

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Authors: Elaine Yee Sing Wong, Jonine Jancey, Andy H. Lee, Anthony P. James

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Singapore has a rapidly aging population, where the majority of older women aged 50 years and above, are physically inactive and have unhealthy dietary habits, placing them at ‘high risk’ of non-communicable diseases. Given the multiplicity of less than optimal dietary habits and high levels of physical inactivity among Singaporean women, it is imperative to develop appropriate lifestyle interventions at recreational centres to enhance both their physical and nutritional knowledge, as well as provide them with the opportunity to develop skills to support behaviour change. To the best of our knowledge, this proposed study is the first physical activity and nutrition cluster randomised controlled trial conducted in Singapore for older women. Findings from this study may provide insights and recommendations for policy makers and key stakeholders to create new healthy living, recreational centres with supportive environments. This 6-month community-based cluster randomised controlled trial will involve the implementation and evaluation of physical activity and nutrition program for community dwelling Singaporean women, who currently attend recreational centres to promote social leisure activities in their local neighbourhood. The intervention will include dietary education and counselling sessions, physical activity classes, and telephone contact by certified fitness instructors and qualified nutritionists. Social Cognitive Theory with Motivational Interviewing will inform the development of strategies to support health behaviour change. Sixty recreational centres located in Singapore will be randomly selected from five major geographical districts and randomly allocated to the intervention (n=30) or control (n=30) cluster. A sample of 600 (intervention n=300; control n=300) women aged 50 years and above will then be recruited from these recreational centres. The control clusters will only undergo pre and post data collection and will not receive the intervention. It is hypothesised that by the end of the intervention, the intervention group participants (n = 300) compared to the control group (n = 300), will show significant improvements in the following variables: lipid profile, body mass index, physical activity and dietary behaviour, anthropometry, mental and physical health. Data collection will be examined and compared via the Statistical Package for the Social Science version 23. Descriptive and summary statistics will be used to quantify participants’ characteristics and outcome variables. Multi-variable mixed regression analyses will be used to confirm the effects of the proposed health intervention, taking into account the repeated measures and the clustering of the observations. The research protocol was approved by the Curtin University Human Research Ethics Committee (approval number: HRE2016-0366). The study has been registered with the Australian and New Zealand Clinical Trial Registry (12617001022358).

Keywords: community based, healthy aging, intervention, nutrition, older women, physical activity

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Authors: Simon B. N. Thompson

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Early indicator of neurological disease has been proposed by the expanded Thompson Cortisol Hypothesis which suggests that yawning is linked to rises in cortisol levels. Cortisol is essential to the regulation of the immune system and pathological yawning is a symptom of multiple sclerosis (MS). Electromyography activity (EMG) in the jaw muscles typically rises when the muscles are moved – extended or flexed; and yawning has been shown to be highly correlated with cortisol levels in healthy people. It is likely that these elevated cortisol levels are also seen in people with MS. The possible link between EMG in the jaw muscles and rises in saliva cortisol levels during yawning were investigated in a randomized controlled trial of 60 volunteers aged 18-69 years who were exposed to conditions that were designed to elicit the yawning response. Saliva samples were collected at the start and after yawning, or at the end of the presentation of yawning-provoking stimuli, in the absence of a yawn, and EMG data was additionally collected during rest and yawning phases. Hospital Anxiety and Depression Scale, Yawning Susceptibility Scale, General Health Questionnaire, demographic, and health details were collected and the following exclusion criteria were adopted: chronic fatigue, diabetes, fibromyalgia, heart condition, high blood pressure, hormone replacement therapy, multiple sclerosis, and stroke. Significant differences were found between the saliva cortisol samples for the yawners, t (23) = -4.263, p = 0.000, as compared with the non-yawners between rest and post-stimuli, which was non-significant. There were also significant differences between yawners and non-yawners for the EMG potentials with the yawners having higher rest and post-yawning potentials. Significant evidence was found to support the Thompson Cortisol Hypothesis suggesting that rises in cortisol levels are associated with the yawning response. Further research is underway to explore the use of cortisol as a potential diagnostic tool as an assist to the early diagnosis of symptoms related to neurological disorders. Bournemouth University Research & Ethics approval granted: JC28/1/13-KA6/9/13. Professional code of conduct, confidentiality, and safety issues have been addressed and approved in the Ethics submission. Trials identification number: ISRCTN61942768. http://www.controlled-trials.com/isrctn/

Keywords: cortisol, electromyography, neurology, yawning

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Authors: Mukesh K. Dwivedi, Rajeshwar N. Srivastava, Amit K. Bhagat, Saloni Raj

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Introduction: Management of Pressure Ulcer (PU) is an ongoing clinical challenge particularly in traumatic paraplegia patients in developing countries where socio economic conditions often dictate treatment modalities. When negative pressure wound therapy (NPWT) was introduced, there were a series of devices (V.A.C., KCI, San Antonio, TX) manufactured. These devices for NPWT are costly and hard to afford by patients in developing countries like India. Considering this limitation, this study was planned to design an RCT to compare NPWT by an indigenized locally constructed NPD and conventional gauze dressing for the treatment of PU. Material and Methods: This RCT (CTRI/2014/09/0050) was conducted in the Department of Orthopaedic Surgery at King George’s Medical University (KGMU), India. Thirty-four (34) subjects of traumatic paraplegia having PU of stage 3 or 4, were enrolled and randomized in two treatment groups (NPWT Group & Conventional dressing group). The outcome measures of this study were surface area and depth of PU, exudates, microorganisms and matrix metalloproteinase-8 (MMP-8) during 0 to 9 weeks follow-ups. Levels of MMP-8 were analyzed in the tissues of PU at week 0, 3, 6 and week 9 by Enzyme Linked Immuno Sorbent Assay (ELISA). Results: Significantly reduced length of PU in NPWT group was observed at week 6 (p=0.04) which further reduced at week 9 (p=0.001) as compared to conventionally treated group. Similarly significant reduction of width and depth of PU was observed in NPWT at week 9 (p<0.05). The exudate became significantly (p=0.001) lower in NPWT group as compared with conventionally treated group from 6th to 9th week. Clearance and conversion of slough into red granulation tissue was significantly higher in NPWT group (p=0.001). At week 9, the wound culture was negative in all the subjects of NPWT group, while it was positive in 10 (41⋅6%) subjects of conventional group. Significantly lower level of MMP-8 was observed in subjects of NPWT group at week 6 (0.006**), and continually more reduction was observed at week 9 (<0.0001**) as compared to the conventional group. Conclusion: NPWT by locally constructed NPD is better wound care procedure for management of PU. Our device gave similar results as commercially available devices. Reduction of level of MMP-8 and increased rate of healing was achieved by negative pressure wound therapy (NPWT) as compared to conventional dressing.

Keywords: NPWT, NPD, MMP8, ELISA

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Authors: Ammal Mokhtar Metwally, Amal Elsaied, Ghada A. Abdel-Latef, Ebtissam M. Salah El-Din, Hanaa R. M. Attia

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The link between various diet therapies and autism is controversial and limited. Nutritional interventions aim to increase antioxidant levels suggesting a positive effect on the improvement of autism severity. In this study, the effectiveness of a 90-day Dates fruits consumption fruits (a non-pharmacological and risk-free option) on alleviating autism severity symptoms in individuals with ASD was investigated. The study examined also whether the baseline or improvements of some of the clinical and laboratory characteristics of the subjects affected their response to dates fruits intake on the severity of ASD symptoms. Methodology: This study involved a randomized controlled, double-blind 3-month dates fruits intake. 131 Egyptian children aged 3-12 years with confirmed ASD were enrolled in the study. cases were randomized in one of the three groups as follows; 1st regimen: Group I on 3 dates’ fruits/day (47 cases), 2nd regimen: Group II on 5 dates’ fruits/day (42 cases), and 3rd regimen: group III; nondates group (42 cases). ASD severity was assessed using both the Diagnostic and statistical manual of mental disorders, 5th ed. (DSM-V) criteria and the Childhood Autism Rating Scale (CARS) analysis. The following measures were assessed before and after the regimens: blood levels of three oxidative markers; Malondialdehyde (MDA), glutathione peroxidase (GPX1), and superoxide dismutase (SOD), nutritional, dietary assessment & anthropometric measurements Results: A significant reduction in the mean score of autism was detected based on CARS scores for those on dates’ regimens compared to those on non-dates (p < 0.01). Participants on 5 dates’ fruits/day for three months showed the highest improvement for autism severity based on both CARS and DSM5 compared to those in 3 dates’ fruits/day and non-dates groups. Responders to dates fruits intake as reflected on the Improvement of autism severity based on CARS diagnosis was detected among 78.7 % and 62.9 % based on CARS and DSM5 diagnosis, respectively. Responders had significant improvement in BMI z score and in the ratio levels of both MDA/SOD and MDA/GPX. Conclusion: The positive results of this study suggest that palm dates fruits could be recommended for children with ASD as adjuvant therapy on a daily regular basis to achieve consistent improvement of autism symptoms Objective: Investigate the effectiveness of a 90-day Dates fruits consumption fruits on alleviating autism severity symptoms in individuals with ASD and explore the clinical and laboratory characteristics of the subjects affected their response to dates fruits intake. Methodology: The study was a randomized controlled, double-blind for 3-month. 131 autistic Egyptian children aged 3-12 years were enrolled in one of the three groups; 1st: on 3 dates’ fruits/day (47 cases), 2nd: Group II on 5 dates’ fruits/day (42 cases), and 3rd: group III; nondates group (42 cases). Conclusion: The positive results of this study suggest that palm dates fruit (a non-pharmacological and risk-free option) could be recommended for children with ASD as adjuvant therapy on a daily regular basis to achieve consistent improvement of autism symptoms.

Keywords: autism spectrum disorders, palm dates fruits, CARS, DSM5, oxidative markers

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Authors: Mkpoikanke Sunday Otu

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Introduction: Career anxiety is a common issue among university students, particularly in developing countries like Nigeria. This anxiety can significantly impact students' academic performance, overall well-being, and future career prospects. Therefore, it is crucial to explore effective interventions that can alleviate career anxiety among university students. The primary aim of this study was to determine the effectiveness of a psychosocial intervention in reducing career anxiety among Nigerian university students. The study employed a group randomized trial research design to further analyze the impact on career anxiety. Methodology: A total of 306 university students from various universities in Akwa Ibom State, Nigeria, were recruited for this study. The participants were purposively selected to ensure diversity and represent a range of academic disciplines. A group randomized trial research design was employed, with participants randomly assigned to either the treatment group or the control group. The treatment group received a comprehensive psychosocial intervention, while the control group served as a comparison group. The Career Anxiety Questionnaire (CAQ) was used to assess career anxiety levels among the participants. The CAQ is a validated and reliable tool that assesses various aspects of career-related anxiety, including uncertainty, fear, and self-doubt. It was administered to the participants at baseline (before the intervention), immediately after the intervention, and at follow-up (after the intervention). Results: Data analysis was conducted using statistical techniques, including analysis of variance (ANOVA). The results demonstrated that the treatment group showed a significantly lower mean score of career anxiety compared to the control group (p-value<0.05). This finding suggests that the psychosocial intervention was effective in reducing the career anxiety levels of the participants at post-test and follow-up. Conclusion: The findings of this study provide compelling evidence that psychosocial interventions have a significant impact on the reduction of career anxiety among Nigerian university students. The treatment group demonstrated a significant reduction in career anxiety scores, indicating the effectiveness of this intervention. Additionally, this study highlights the importance of addressing the career anxiety challenges faced by university students. By implementing targeted interventions, educational institutions can play a vital role in supporting the overall well-being and success of their students, both academically and professionally.

Keywords: psychosocial intervention, career anxiety, psychoeducation, university students

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Authors: Sadam Elayah

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Background: One of the most critical competencies in advanced dentistry is alveolar ridge preservation after exodontia. The aim of this clinical trial was to assess the impact of autologous concentrated growth factor (CGF) as a socket-filling material and its ridge preservation properties following the lower third molar extraction. Materials and Methods: A total of 60 sides of 30 participants who had completely symmetrical bilateral impacted lower third molars were enrolled. The short-term outcome variables were wound healing, swelling and pain, clinically assessed at different time intervals (1st, 3rd & 7th days). While the long-term outcome variables were bone height & width, bone density and socket surface area in the coronal section. Cone beam computed tomography images were obtained immediately after surgery and three months after surgery as a temporal measure. Randomization was achieved by opaque, sealed envelopes. Follow-up data were compared to baseline using Paired & Unpaired t-tests. Results: The wound healing index was significantly better in the test sides (P =0.001). Regarding the facial swelling, the test sides had significantly fewer values than the control sides, particularly on the 1st (1.01±.57 vs 1.55 ±.56) and 3rd days (1.42±0.8 vs 2.63±1.2) postoperatively. Nonetheless, the swelling disappeared within the 7th day on both sides. The pain scores of the visual analog scale were not a statistically significant difference between both sides on the 1st day; meanwhile, the pain scores were significantly lower on the test sides compared with the control sides, especially on the 3rd (P=0.001) and 7th days (P˂0.001) postoperatively. Regarding long-term outcomes, CGF sites had higher values in height and width when compared to Control sites (Buccal wall 32.9±3.5 vs 29.4±4.3 mm, Lingual wall 25.4±3.5 vs 23.1±4 mm, and Alveolar bone width 21.07±1.55vs19.53±1.90 mm) respectively. Bone density showed significantly higher values in CGF sites than in control sites (Coronal half 200±127.3 vs -84.1±121.3, Apical half 406.5±103 vs 64.2±158.6) respectively. There was a significant difference between both sites in reducing periodontal pockets. Conclusion: CGF application following surgical extraction provides an easy, low-cost, and efficient option for alveolar ridge preservation. Thus, dentists may encourage using CGF during dental extractions, particularly when alveolar ridge preservation is required.

Keywords: platelet, extraction, impacted teeth, alveolar ridge, regeneration, CGF

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Authors: Sergey M. Karabanov, Dmitry V. Suvorov, Dmitry Yu. Tarabrin

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The operating principle of magnetically controlled microelectromechanical system (MEMS) switches is based on controlling the beam movement under the influence of a magnetic field. Currently, there is a MEMS switch design with a flexible ferromagnetic electrode in the form of a fixed-terminal beam, with an electrode fastened on a straight or cranked anchor. The basic performance characteristics of magnetically controlled MEMS switches (service life, sensitivity, contact resistance, fast response) are largely determined by the flexible electrode design. To ensure the stable and controlled motion of the flexible electrode, it is necessary to provide the optimal design of a flexible electrode.

Keywords: flexible electrode, magnetically controlled MEMS, mathematical modeling, mechanical stress

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Authors: B. Nakhostin-Roohi, F. Khoshkhahesh, KH. Parandak, R. Ramazanzadeh

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Introduction: The protective effect of antioxidants in diminishing the post-exercise rise of serum CK and LDH in individuals trained for competitive sports has come to light in recent years. This study was conducted to assess the effect of Two-week L-carnitine supplementation on exercise-induced muscle damage, as well as antioxidant capacity after a bout of strenuous exercise in active healthy young men. Methodology: Twenty active healthy men volunteered for this study. Participants were randomized in a double-blind placebo-controlled fashion into two groups: L-carnitine (C group; n = 10) and placebo group (P group; n = 10). The participants took supplementation (2000 mg L-carnitine) or placebo (2000 mg lactose) daily for 2weeks before the main trial. Then, participants ran 14 km. Blood samples were taken before supplementation, before exercise, immediately, 2h and 24h after exercise. Creatine kinase (CK), and lactate dehydrogenase (LDH), and total antioxidant capacity (TAC) were measured. Results: Serum CK and LDH significantly increased after exercise in both groups (p < 0.05). Serum LDH was significantly lower in C group than P group 2h and 24h after exercise (p < 0.05). Furthermore, CK was significantly lower in C group compared with P group just 24h after exercise (p < 0.05). Plasma TAC increased significantly 14 days after supplementation and 24h after exercise in C group compared with P group (p < 0.05). Discussion and conclusion: These results suggest two-week daily oral supplementation of L-carnitine has been able to promote antioxidant capacity before and after exercise and decrease muscle damage markers through possibly inhibition of exercise-induced oxidative stress.

Keywords: L-carnitine, muscle damage, creatine kinase, Lactate dehydrogenase

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Authors: Caio E. G. Reis, Sara Wassell, Adriana L. Porto, Angélica A. Amato, Leslie J. C. Bluck, Teresa H. M. da Costa

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Background: Multiple epidemiologic studies have consistently reported association between increased coffee consumption and a lowered risk of Type 2 Diabetes Mellitus. However, the mechanisms behind this finding have not been fully elucidated. Objective: We investigate the effect of coffee (caffeinated and decaffeinated) on glucose effectiveness and insulin sensitivity using the stable isotope minimal model protocol with oral glucose administration in healthy men. Design: Fifteen healthy men underwent 5 arms randomized crossover single-blinding (researchers) clinical trial. They consumed decaffeinated coffee, caffeinated coffee (with and without sugar), and controls – water (with and without sugar) followed 1 hour by an oral glucose tolerance test (75 g of available carbohydrate) with intravenous labeled dosing interpreted by the two compartment minimal model (225 minutes). One-way ANOVA with Bonferroni adjustment were used to compare the effects of the tested beverages on glucose metabolism parameters. Results: Decaffeinated coffee resulted in 29% and 85% higher insulin sensitivity compared with caffeinated coffee and water, respectively, and the caffeinated coffee showed 15% and 60% higher glucose effectiveness compared with decaffeinated coffee and water, respectively. However, these differences were not significant (p > 0.10). In overall analyze (0 – 225 min) there were no significant differences on glucose effectiveness, insulin sensitivity, and glucose and insulin area under the curve between the groups. The beneficial effects of coffee did not seem to act in the short-term (hours) on glucose metabolism parameters mainly on insulin sensitivity indices. The benefits of coffee consumption occur in the long-term (years) as has been shown in the reduction of Type 2 Diabetes Mellitus risk in epidemiological studies. The clinical relevance of the present findings is that there is no need to avoid coffee as the drink choice for healthy people. Conclusions: The findings of this study demonstrate that the consumption of caffeinated and decaffeinated coffee with or without sugar has no acute effects on glucose metabolism in healthy men. Further researches, including long-term interventional studies, are needed to fully elucidate the mechanisms behind the coffee effects on reduced risk for Type 2 Diabetes Mellitus.

Keywords: coffee, diabetes mellitus type 2, glucose, insulin

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Authors: Yungtai Lo

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Two-part random effects models have been used to fit semi-continuous longitudinal data where the response variable has a point mass at 0 and a continuous right-skewed distribution for positive values. We review methods proposed in the literature for analyzing data with excess zeros. A two-part logit-log-normal random effects model, a two-part logit-truncated normal random effects model, a two-part logit-gamma random effects model, and a two-part logit-skew normal random effects model were used to examine effects of a bottle-weaning intervention on reducing bottle use and daily milk intake from bottles in toddlers aged 11 to 13 months in a randomized controlled trial. We show in all four two-part models that the intervention promoted bottle-weaning and reduced daily milk intake from bottles in toddlers drinking from a bottle. We also show that there are no differences in model fit using either the logit link function or the probit link function for modeling the probability of bottle-weaning in all four models. Furthermore, prediction accuracy of the logit or probit link function is not sensitive to the distribution assumption on daily milk intake from bottles in toddlers not off bottles.

Keywords: two-part model, semi-continuous variable, truncated normal, gamma regression, skew normal, Pearson residual, receiver operating characteristic curve

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Authors: Essam Amerian

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The aim of this study was to investigate the effects of improving waist-to-hip ratio (WHR) and visceral fat components on the health of shift workers in an offshore petrochemical company. A total of 100 male shift workers participated in the study, with an average age of 40.5 years and an average BMI of 28.2 kg/m². The study employed a randomized controlled trial design, with participants assigned to either an intervention group or a control group. The intervention group received a 12-week program that included dietary counseling, physical activity recommendations, and stress management techniques. The control group received no intervention. The outcomes measured were changes in WHR, visceral fat components, blood pressure, and lipid profile. The results showed that the intervention group had a statistically significant improvement in WHR (p<0.001) and visceral fat components (p<0.001) compared to the control group. Furthermore, there were statistically significant improvements in systolic blood pressure (p=0.015) and total cholesterol (p=0.034) in the intervention group compared to the control group. These findings suggest that implementing a 12-week program that includes dietary counseling, physical activity recommendations, and stress management techniques can effectively improve WHR, visceral fat components, and cardiovascular health among shift workers in an offshore petrochemical company.

Keywords: body composition, waist-hip-ratio, visceral fat, shift worker, work efficiency

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Authors: Boshra Mozaffar, Arash Ardavani, Iskandar Idris

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Food taste and flavor affect food choice and acceptance, which are essential to maintain good health and quality of life. Reduced circulating zinc levels have been shown to adversely affect taste which can result in reduced appetite, weight loss and psychological problems, but the efficacy of Zinc supplementation to treat disorders of taste remains unclear. In this systematic review and meta-analysis, we aimed to examine the efficacy of zinc supplementation in the treatment of taste disorders. We searched four electronic bibliographical databases; Ovid MEDLINE, Ovid Embase, Ovid AMAD and PubMed. Article bibliographies were also searched, which yielded additional relevant studies. To facilitate the collection and identification of all available and relevant articles published before 7 December 2020, there were no restrictions on the publication date. We performed a systematic review and meta-analysis according to the PRISMA Statement. This review was registered at PROSPERO and given the identification number CRD42021228461. In total, we included 12 randomized controlled trials with 938 subjects. Intervention includes zinc (sulfate, gluconate, picolinate, polaprezinc and acetate); the pooled results of the meta-analysis indicate that improvements in taste disorder occurred more frequently in the intervention group compared to the control group (RR = 1.8; 95% CI:1.27 -2.57, p=0.009). The doses are equivalent to 17 mg- 86.7 mg of elemental zin for three to six months. Zinc supplementation is an effective treatment for taste disorders in patients with zinc deficiency or idiopathic taste disorders when given in high doses ranging from 68–86.7 mg/d for up to three months. However, we did not find sufficient evidence to determine the effectiveness of zinc supplementation in patients with taste disorders induced by chronic renal failure.

Keywords: taste change, taste disorder, zinc, zinc sulfate or Zn, deficiency, supplementation.

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Authors: Giannis Arnaoutis, Dimitra Efthymiopoulou, Maria-Foivi Nikolopoulou, Yannis Manios

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AIM: Nitrate-containing supplements have been used extensively as ergogenic in many sports. However, extract fractions from plant-based nutritional sources high in nitrate and their effect on athletic performance, has not been systematically investigated. The purpose of the present study was to examine the possible effect of acute consumption of a “smart mixture” from beetroot and rocket on exercise capacity. MATERIAL & METHODS: 12 healthy, nonsmoking, recreationally active, males (age: 25±4 years, % fat: 15.5±5.7, Fat Free Mass: 65.8±5.6 kg, VO2 max: 45.46.1 mL . kg -1 . min -1) participated in a double-blind, placebo-controlled trial study, in a randomized and counterbalanced order. Eligibility criteria for participation in this study included normal physical examination, and absence of any metabolic, cardiovascular, or renal disease. All participants completed a time to exhaustion cycling test at 75% of their maximum power output, twice. The subjects consumed either capsules containing 360 mg of nitrate in total or placebo capsules, in the morning, under fasted state. After 3h of passive recovery the performance test followed. Blood samples were collected upon arrival of the participants and 3 hours after the consumption of the corresponding capsules. Time until exhaustion, pre- and post-test lactate concentrations, and rate of perceived exertion for the same time points were assessed. RESULTS: Paired-sample t-test analysis found a significant difference in time to exhaustion between the trial with the nitrate consumption versus placebo [16.1±3.0 Vs 13.5±2.6 min, p=0.04] respectively. No significant differences were observed for the concentrations of lactic acid as well as for the values in the Borg scale between the two trials (p>0.05). CONCLUSIONS: Based on the results of the present study, it appears that a nutritional supplement derived from vegetable extracts rich in nitrate, improves athletic performance in recreationally active young males. However, the precise mechanism is not clear and future studies are needed. Acknowledgment: This research has been co‐financed by the European Regional Development Fund of the European Union and Greek national funds through the Operational Program Competitiveness, Entrepreneurship and Innovation, under the call RESEARCH – CREATE – INNOVATE (project code:T2EDK-00843).

Keywords: sports performance, ergogenic supplements, nitrate, extract fractions

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Authors: Anu Jose, Sapna Nair

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By using the baseline data of a randomized cluster trial aiming to understand the effects of social, technological and business innovation on child development in two districts of Tamil Nadu, India, we examine the determinants of father involvement in childcare. While there is a growing literature on the role of fathers in child development and family systems, we particularly look at the effect of the attitude of mother and father towards father's involvement in childcare in rural South India. We find that father's own attitude and the mother's gatekeeping attitude significantly affect the father's behavior when other socio-economic characteristics of the parents are controlled. Further, the results are corroborated using different empirical models in which father involvement is conceptualized into three categories broadly; play, caretaking, and affection. We also examine the other socio-economic characteristics affecting paternal involvement using both quantitative and qualitative methods. For instance, child characteristics such as the age and birth order have a significant influence on the level of paternal involvement. That is, older the child, the more involved the father is and the father gets more involved in childcare of the second child as compared to the first child. The participants of the study included 1516 children of age 0 to 22 months from 1476 households. Results indicate that fathers of households where the mother and the father have less traditional attitude exhibit a higher level of involvement in childcare as opposed to parents having a more traditional attitude towards gender role in parenting. The results of this paper provide a major policy lesson aiming to improve paternal involvement in childcare.

Keywords: child development, father involvement, gender, parent’s attitude towards paternal involvement

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Authors: Zyrah Lou R. Samar, Genecarlo Liwanag

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Type 2 Diabetes Mellitus is the more prevalent type, caused by a combination of insulin resistance and inadequate insulin response to hyperglycemia1. Aside from pharmacologic interventions, medical nutrition therapy is an integral part of the management of patients with Type 2 Diabetes Mellitus. Whey protein, which is one of the best protein sources, has been investigated for its applicability in improving glycemic control in patients with Type 2 Diabetes Mellitus. This systematic review and meta-analysis was conducted to measure the magnitude of the effect of whey protein on glycemic control in type 2 diabetes mellitus. The aim of this review is to evaluate the efficacy and safety of whey protein in patients with type 2 diabetes mellitus. Methods: A systematic electronic search for studies in the PubMed and Cochrane Collaboration database was done. Included in this review were randomized controlled trials of whey protein enrolling patients with type 2 diabetes mellitus. Three reviewers independently searched, assessed, and extracted data from the individual studies. Results: A systematic literature search on online databases such as Cochrane Central Registry, PubMed, and Herdin Plus was conducted in April to September 2021 to identify eligible studies. The search yielded 21 randomized controlled trials after removing duplicates. Only 5 articles were included after reviewing the full text, which met the criteria for selection. Conclusion: Whey protein supplementation significantly reduced fasting blood glucose. However, it did not reduce post-prandial blood glucose, HbA1c level, and weight when compared with the placebo. There has been a considerate heterogeneity across all studies, which may have contributed/confounded its effects. A larger sample size and better inclusion, and a more specific study may be included in the future reviews.

Keywords: whey protein, diabetes, nutrition, fasting blood sugar, postprandial glucose, HbA1c, weight reduction

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Authors: Omar Mayyas

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Clinical decision-making (CDM) is essential to community health nursing (CHN) education. For this reason, nursing educators are responsible for developing these skills among nursing students because nursing students are exposed to highly critical conditions after graduation. However, due to limited exposure to real-world situations, many nursing students need help developing clinical decision-making skills in this area. Therefore, the impact of Virtual Simulation (VS) on community health nursing students' clinical decision-making in nursing education has to be investigated. This study aims to examine the difference in CDM ability among CHN students who received traditional education compared to those who received VS classes, to identify the factors that may influence CDM ability differences between CHN students who received a traditional education and VS classes, and to provide recommendations for educational programs that can enhance the CDM ability of CHN students and improve the quality of care provided in community settings. A mixed-method study will conduct. A randomized controlled trial will compare the CDM ability of CHN students who received 1hr traditional class with another group who received 1hr VS scenario about diabetic patient nursing care. Sixty-four students in each group will randomly select to be exposed to the intervention from undergraduate nursing students who completed the CHN course at York University. The participants will receive the same Clinical Decision Making in Nursing Scale (CDMNS) questionnaire. The study intervention will follow the Medical Research Council (MRC) approach. SPSS and content analysis will use for data analysis.

Keywords: clinical decision-making, virtual simulation, community health nursing students, community health nursing education

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Authors: F. Arslan, S.D. Guven, A. Özcan, H. Vatansev, Ö. Taşgin

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Weight, hypertension and dyslipidemia control and increased physical activity are required for the treatment of metabolic syndrome (METS). The purpose of this study was to investigate the effect of core exercise, reflexology and intake chrome picolinate on METS. This study comprised a twelve-week randomized controlled trial. A total of 25 university workers with metabolic risk factors participated in this study voluntarily. They were randomly divided into three groups: Those undertaking a core exercise program (n=7), reflexology intervention group (n=8) and intake chrome group (n=10). The subjects took part in a core exercise program for one hour per day, three days a week and a reflexology interfered for thirty minutes per day, one days a week and chrome group took chrome picolinate every day in week for twelve weeks. The components of metabolic syndrome were analyzed before and after the completion of all the intervention. There were significant differences at pre-prandial blood glucose in the core exercise group and at systolic blood pressure in chrome group after the twelve week interventions (p < 0.005). While High Density Lipoprotein (HDL) excluding the components of METS decreased after the interventions on the all groups; levels of HDL and the other components of METS decreased in reflexology group. There was a clear response to the twelve-week interventions in terms of METS control. Besides, the reflexology intervention should not be applied to individuals with low HDL levels and core exercise and intake chrome picolinate suggested to improve the components of METS.

Keywords: blood pressure, body mass index, exercise, METS, pre-prandial blood glucose

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Authors: Vijaya Kumar, Vidayasagar Pagilla, Abraham Joshua, Rakshith Kedambadi, Prasanna Mithra

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Background: Post stroke rehabilitation are aimed to accelerate for optimal sensorimotor recovery, functional gain and to reduce long-term dependency. Intensive physical therapy interventions can enhance this recovery as experience-dependent neural plastic changes either directly act at cortical neural networks or at distal peripheral level (muscular components). Neuromuscular Electrical Stimulation (NMES), a traditional bottom-up approach, mirror therapy (MT), a relatively new top down approach have found to be an effective adjuvant treatment methods for lower extremity motor and functional recovery in stroke rehabilitation. However there is a scarcity of evidence to compare their therapeutic gain in stroke recovery.Aim: To compare the efficacy of neuromuscular electrical stimulation (NMES) and mirror therapy (MT) in very early phase of post stroke rehabilitation addressed to lower extremity motor recovery and balance. Design: observer blinded Randomized Clinical Trial. Setting: Neurorehabilitation Unit, Department of Physical Therapy, Tertiary Care Hospitals. Subjects: 32 acute stroke subjects with first episode of unilateral stroke with hemiparesis, referred for rehabilitation (onset < 3 weeks), Brunnstorm lower extremity recovery stages ≥3 and MMSE score more than 24 were randomized into two group [Group A-NMES and Group B-MT]. Interventions: Both the groups received eclectic approach to remediate lower extremity recovery which includes treatment components of Roods, Bobath and Motor learning approaches for 30 minutes a day for 6 days. Following which Group A (N=16) received 30 minutes of surface NMES training for six major paretic muscle groups (gluteus maximus and medius,quadriceps, hamstrings, tibialis anterior and gastrocnemius). Group B (N=16) was administered with 30 minutes of mirror therapy sessions to facilitate lower extremity motor recovery. Outcome measures: Lower extremity motor recovery, balance and activities of daily life (ADLs) were measured by Fugyl Meyer Assessment (FMA-LE), Berg Balance Scale (BBS), Barthel Index (BI) before and after intervention. Results: Pre Post analysis of either group across the time revealed statistically significant improvement (p < 0.001) for all the outcome variables for the either group. All parameters of NMES had greater change scores compared to MT group as follows: FMA-LE (25.12±3.01 vs. 23.31±2.38), BBS (35.12±4.61 vs. 34.68±5.42) and BI (40.00±10.32 vs. 37.18±7.73). Between the groups comparison of pre post values showed no significance with FMA-LE (p=0.09), BBS (p=0.80) and BI (p=0.39) respectively. Conclusion: Though either groups had significant improvement (pre to post intervention), none of them were superior to other in lower extremity motor recovery and balance among acute stroke subjects. We conclude that eclectic approach is an effective treatment irrespective of NMES or MT as an adjunct.

Keywords: balance, motor recovery, mirror therapy, neuromuscular electrical stimulation, stroke

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Authors: Enas El Sayed Abutaleb, Mohamed Taher Eldesoky, Shahenda Abd El Rasol

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Background: Muscle energy techniques (MET) have been widely used by manual therapists over the past years, but still limited research validated its use and there was limited evidence to substantiate the theories used to explain its effects. Objective: To investigate the effect of muscle energy technique (MET) on anterior pelvic tilt in patients with lumbar spondylosis. Design: Randomized controlled trial. Subjects: Thirty patients with anterior pelvic tilt from both sexes were involved, aged between 35 to 50 years old and they were divided into MET and control groups with 15 patients in each. Methods: All patients received 3 sessions/week for 4 weeks where the study group received MET, Ultrasound and Infrared, and the control group received U.S and I.R only. Pelvic angle was measured by palpation meter, pain severity by the visual analogue scale and functional disabilities by the Oswestry disability index. Results: Both groups showed significant improvement in all measured variables. The MET group was significantly better than the control group in pelvic angle, pain severity, and functional disability as p-value were (0.001, 0.0001, 0.0001) respectively. Conclusion and implication: The study group fulfilled greater improvement in all measured variables than the control group which implies that application of MET in combination with U.S and I.R were more effective in improving pelvic tilting angle, pain severity and functional disabilities than using electrotherapy only.

Keywords: anterior pelvic tilt, lumbar spondylosis, muscle energy technique exercise, pelvic tilting angle

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Authors: Antonio Lopez-Villegas, Rafael Bautista-Mesa, Emilio Robles-Musso, Daniel Catalan-Matamoros, Cesar Leal-Costa

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Objectives: The purpose of this trial was to evaluate the burden borne by and the costs to informal caregivers of users with telemonitoring of pacemakers. Methods: This is a controlled, non-randomised clinical trial, with data collected from informal caregivers, five years after implantation of pacemakers. The Spanish version of the Survey on Disabilities, Personal Autonomy, and Dependency Situations was used to get information on clinical and social characteristics, levels of professionalism, duration and types of care, difficulties in providing care, health status, economic and job aspects, impact on the family or leisure due to informal caregiving for patients with pacemakers. Results: After five years of follow-up, 55 users with pacemakers finished the study. Of which, 50 were helped by a caregiver, 18 were included in the telemonitoring group (TM) and 32 in the conventional follow-up group (HM). Overall, females represented 96.0% of the informal caregivers (88.89% in TM and 100.0% in HM group). The mean ages were 63.17 ± 15.92 and 63.13 ± 14.56 years, respectively (p = 0.83) in the groups. The majority (88.0%) of the caregivers declared that they had to provide their services between 6 and 7 days per week (83.33% in TM group versus 90.63% in HM group), without significant differences between both groups. The costs related to care provided by the informal caregivers were 47.04% higher in the conventional follow-up group than in the TM group. Conclusions: The results of this trial confirm that there were no significant differences between the informal caregivers regarding to baseline characteristics, workload and time worked in both groups of follow-up. The costs incurred by the informal caregivers providing care for users with pacemakers included in telemonitoring group are significantly lower than those in the conventional follow-up group. Trial registration: ClinicalTrials.gov NCT02234245. Funding: The PONIENTE study, has been funded by the General Secretariat for Research, Development and Innovation, Regional Government of Andalusia (Spain), project reference number PI/0256/2017, under the research call 'Development and Innovation Projects in the Field of Biomedicine and Health Sciences', 2017.

Keywords: costs, disease burden, informal caregiving, pacemaker follow-up, remote monitoring, telemedicine

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Authors: Jiayan Gou, Kexin He, Xin Zhang, Fei Wang, Liuni Zou

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Background: Homocysteine is a high-risk factor for cognitive decline, and folic acid supplementation can lower homocysteine levels. However, current clinical research results are inconsistent, and the effects of folic acid on homocysteine levels and cognitive function in older people are inconsistent. Objective: The objective of this study is to systematically evaluate the effects of folic acid alone or in combination with other nutrients on homocysteine levels and cognitive function in older adults. Methods: Systematic searches were conducted in five databases, including PubMed, Embase, the Cochrane Library, Web of Science, and CINAHL, from inception to June 1, 2023. Randomized controlled trials were included investigating the effects of folic acid alone or in combination with other nutrients on cognitive function in older people. Results: 17 articles were included, with six focusing on the effects of folic acid alone and 11 examining folic acid in combination with other nutrients. The study included 3,100 individuals aged 60 to 83.2 years, with a relatively equal gender distribution (approximately 51.82% male). Conclusion: Folic acid alone or combined with other nutrients can effectively lower homocysteine level and improve cognitive function in patients with mild cognitive impairment. But for patients with Alzheimer's disease and dementia, the intervention only can reduce the homocysteine level, but the improvement in cognitive function is not significant. In healthy older people, high baseline homocysteine levels (>11.3 μmol/L) and good ω-3 fatty acid status (>590 μmol/L) can enhance the improvement effect of folic acid on cognitive function. This trial has been registered on PROSPERO as CRD42023433096.

Keywords: B-complex vitamins, cognitive function, folic acid, homocysteine

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Authors: Van Truong Pham

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Background: Self-management was described as a potential strategy for blood pressure control in patients with hypertension. However, the effects of self-management interventions on blood pressure, self-efficacy, medication adherence, and body mass index (BMI) in older adults with hypertension have not been systematically evaluated. We evaluated the effects of self-management interventions on systolic blood pressure (SBP) and diastolic blood pressure (DBP), self-efficacy, medication adherence, and BMI in hypertensive older adults. Methods: We followed the recommended guidelines of preferred reporting items for systematic reviews and meta-analyses. Searches in electronic databases including CINAHL, Cochrane Library, Embase, Ovid-Medline, PubMed, Scopus, Web of Science, and other sources were performed to include all relevant studies up to April 2019. Studies selection, data extraction, and quality assessment were performed by two reviewers independently. We summarized intervention effects as Hedges' g values and 95% confidence intervals (CI) using a random-effects model. Data were analyzed using Comprehensive Meta-Analysis software 2.0. Results: Twelve randomized controlled trials met our inclusion criteria. The results revealed that self-management interventions significantly improved blood pressure control, self-efficacy, medication adherence, whereas the effect of self-management on BMI was not significant in older adult patients with hypertension. The following Hedges' g (effect size) values were obtained: SBP, -0.34 (95% CI, -0.51 to -0.17, p < 0.001); DBP, -0.18 (95% CI, -0.30 to -0.05, p < 0.001); self-efficacy, 0.93 (95%CI, 0.50 to 1.36, p < 0.001); medication adherence, 1.72 (95%CI, 0.44 to 3.00, p=0.008); and BMI, -0.57 (95%CI, -1.62 to 0.48, p = 0.286). Conclusions: Self-management interventions significantly improved blood pressure control, self-efficacy, and medication adherence. However, the effects of self-management on obesity control were not supported by the evidence. Healthcare providers should implement self-management interventions to strengthen patients' role in managing their health care.

Keywords: self-management, meta-analysis, blood pressure control, self-efficacy, medication adherence, body mass index

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