Search results for: randomized control trial

Authors: Ghada M. R. Koura, Mohamed N. Mohamed, Ahmed M. F. El Shiwi

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Chronic mechanical Low back dysfunction (CMLBD) is the most common problem of the working-age population in modern industrial sociaty; it causes a substantial economic burden due to the wide use of medical services and absence from work. Aim of work: the aim of this study was to investigate the effect of positional release technique on patients with chronic mechanical low back pain. Materials and Methods: Thirty two patients from both sexes were diagnosed with CMLBP, aged 20 to 45 years and were divided randomly into two equal groups; sixteen patients each; group A (control group) received therapeutic exercises that include (Stretch and Strength exercises for back and abdominal muscles). Group B (experimental group) received therapeutic exercises with positional release technique; treatment was applied 3 days/week for 4 weeks. Pain was measured by Visual Analogue Scale, Lumbar range of motion was measured by Inclinometer and Functional disability was measured by Oswestry disability scale. Measurements were taken at two intervals pre-treatment and post-treatment. Results: Data obtained was analyzed via paired and unpaired t-Test. There were statistical differences between the 2 groups, where the experimental group showed greater improvement than control group. Conclusion: Positional release technique is considered as an effective treatment for reducing pain, functional disability and increasing lumbar range of motion in individuals with chronic mechanical low back pain.

Keywords: chronic mechanical low back pain, traditional physical therapy program, positional release technique, randomized controlled trial

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Authors: Moustafa Ibrahim Moustafa

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The purpose of this study was to determine the immediate and long term effects of a multimodal program, with the addition of cervical sagittal curve restoration and forward head correction, on severity of dizziness, disability, frequency of dizziness, and severity of cervical pain. 72 patients with cervicogenic dizziness, definite hypolordotic cervical spine, and forward head posture were randomized to experimental or a control group. Both groups received the multimodal program, additionally, the study group received the Denneroll cervical traction. All outcome measures were measured at three intervals. The general linear model indicated a significant group × time effects in favor of experimental group on measures of anterior head translation (F=329.4 P < .0005), cervical lordosis (F=293.7 P < .0005), severity of dizziness (F=262.1 P < .0005), disability (F=248.9 P < .0005), frequency of dizziness (F=53.9 P < .0005), and severity of cervical pain (F=350.1 P < .0005). The addition of Dennroll cervical traction to a multimodal program can positively affect dizziness management outcomes.

Keywords: randomized controlled trial, traction, dizziness, cervical

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Authors: Maryam Panahi

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Background: Adjuvants such as ketamine, promethazine, and paracetamol could bring up patient's satisfaction and control the harmful effects of opioids besides lessening their needed doses, as seen by the fentanyl/paracetamol and fentanyl/ketamine combination before. The current study is headed to compare paracetamol and ketamine, in addition to fentanyl, applied by infusion pumps in order to pain relief following major surgery. Materials and Methods: Through a double-blinded, randomized clinical trial, patients between18 and 65 with elective surgery for tight or leg fractures with ASA Class 1 and 2 referred to a university hospital in Arak, a town in the central region of Iran, were recruited and used infusion pump for their postoperative pain control. The participants were divided into cases and controls regarding using ketamine/fentanyl (KF) or paracetamol/fentanyl (PF) infusion pumps. Results: The mean pain score was a total of 3.87, with the highest value in KF (5.06) and the lowest in PF (4.50) immediately after finishing the surgery and getting conscious when started using an infusion pump. There was no statistical difference between the groups in this regard. Concerning the side effects of the applied medications, blood pressure and heart rate had no differences comparing the groups. Conclusion: This study showed that paracetamol used in infusion pumps could be brilliant in pain control after major surgeries like those done in lower extremities and joint replacement while lessening opioid use. Although paracetamol was more effective than ketamine in the current trial, more qualified studies at bigger sizes and in other fields of surgery besides orthopedic ones would be useful to support the effects if applicable

Keywords: infusion pump, Ketamine, Paracetamol, pain

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Authors: P. Vindin, R. Cordier, N. J. Wilson, H. Lee

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Engagement in community-based activities such as education, employment, and social relationships can improve the quality of life for individuals with Autism Spectrum Disorder (ASD). Community mobility is vital to attaining independence for individuals with ASD. Learning to drive and gaining a driver’s license is a critical link to community mobility; however, for individuals with ASD acquiring safe driving skills can be a challenging process. Issues related to anxiety, executive function, and social communication may affect driving behaviours. Driving training and education aimed at addressing barriers faced by learner drivers with ASD can help them improve their driving performance. A multi-site randomized controlled trial (RCT) was conducted to evaluate the effectiveness of an autism-specific driving training intervention for improving the on-road driving performance of learner drivers with ASD. The intervention was delivered via a training manual and interactive website consisting of five modules covering varying driving environments starting with a focus on off-road preparations and progressing through basic to complex driving skill mastery. Seventy-two learner drivers with ASD aged 16 to 35 were randomized using a blinded group allocation procedure into either the intervention or control group. The intervention group received 10 driving lessons with the instructors trained in the use of an autism-specific driving training protocol, whereas the control group received 10 driving lessons as usual. Learner drivers completed a pre- and post-observation drive using a standardized driving route to measure driving performance using the Driving Performance Checklist (DPC). They also completed anxiety, executive function, and social responsiveness measures. The findings showed that there were significant improvements in driving performance for both the intervention (d = 1.02) and the control group (d = 1.15). However, the differences were not significant between groups (p = 0.614) or study sites (p = 0.842). None of the potential moderator variables (anxiety, cognition, social responsiveness, and driving instructor experience) influenced driving performance. This study is an important step toward improving community mobility for individuals with ASD showing that an autism-specific driving training intervention can improve the driving performance of leaner drivers with ASD. It also highlighted the complexity of conducting a multi-site design even when sites were matched according to geography and traffic conditions. Driving instructors also need more and clearer information on how to communicate with learner drivers with restricted verbal expression.

Keywords: autism spectrum disorder, community mobility, driving training, transportation

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Authors: Todd Jackson

Abstract:

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: Jeewantha Ranawaka, Gunawardane Kapila, Wijethunaga Mudiyanselage B. G. Jayathilake

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Introduction: Sweeping of the membranes is a fairly simple technique that may positively influence the shift from maintenance of pregnancy to the beginning of labor. Objective: To assess the effectiveness and acceptability of twice versus once-only membrane sweeping in uncomplicated primi gravid at 40 weeks of gestational age in a tertiary care hospital in Sri Lanka. Methods: A randomized controlled clinical trial was done in Ward 05 of Teaching Hospital, Kandy. The participants were primi-gravida with a singleton live fetus who was at 40 weeks of gestation with intact fetal membranes and with a Modified Bishop’s score <5. After randomization both groups received membrane sweeping at 40 weeks of gestation and the experimental group received membrane sweeping after 48 hours (40+2 days). The modified Bishop Score was assessed at 40+5 days. In two groups who did not go into natural labor at 40+5 days were managed according to the ward policy of cervical ripening and with labor induction at 40+5 days. Two different methods were used to assess discomfort and pain. Patient acceptability was assessed using recommendation to another patient and acceptance during next pregnancy. Perinatal, maternal and labour outcomes were assessed. Results: A change of the Bishops score was 67.3% (n= 31 of 46) in experimental group whereas in control group it was 57.5% (n= 38 of 66). (p = 0.21, OR-1.52, CI = 0.6 -3.34). Mean (SD) of Modified Bishop score was 6.36 (1.94) in experimental group and 6.03 (.84) in control group (p = 0.354). The probability of having the spontaneous onset of labour in experimental group was 61.6% (n=74 of 120) whereas in control group it was 45% (n= 54 of 120) (p=0.01, OR-1.966, CI = 1.17 – 3.28 NNT = 5.99). Recommending the method to another among experimental group was 75% (n= 90 of 120) whereas in control group it was 79.2% (n= 95 of 120) (p= 0.443). Accepting membrane Sweeping for subsequent pregnancy among experimental was 72.5% (n=87 of 120) whereas in control group was 72.5% (n=87 of 120) (p= 1.00) Need of formal induction of labour at 40+ 5 days in experimental group was 38.4% (n=46 of 120) whereas in control group was 61.6% (n=66 of 120) (p=0.01, OR=0.5, CI= 0.3 – 0.8, NNT=6). Neonatal outcome, labour outcome such as Cesarean -section rate, need for augmentation and maternal complications such as fever, Premature rupture of membrane, bleeding were comparable in two groups. Conclusions and Recommendations: It can be concluded that twice sweeping of membrane was effective to reduce the need of formal induction of labour and increase the chances of having spontaneous onset of labour (SOL) at 40+5 days without increasing maternal or fetal morbidity. Acceptability of twice sweeping is not different from sweeping once. Hence we recommend consideration of multiple membranes sweeping as first line for women at 40 weeks of gestation.

Keywords: acceptability, induction, labour, membrane sweeping

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Authors: Hung Manh Nguyen, Duong Dai Nguyen

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Objective: To evaluate the effects of Tai Chi exercise on cognitive performance of community-dwelling elderly in Vinh city, Vietnam. Design: A randomized controlled trial. Participants: One hundred and two subjected were recruited. Intervention: Subjects were divided randomly into two groups. Tai Chi group was assigned 6-months Tai Chi training. Control group was instructed to maintain their routine daily activities. Outcome measures: Trail Making Test (TMT) is primary outcome measure. Results: Participants in Tai Chi group reported significant improvement in TMT (part A) F(1, 71) = 78.37, p < .001, and in TMT (part B) F(1, 71)= 175.00, p < .001 in comparison with Control group. Conclusion: Tai Chi is beneficial to improve cognitive performance of the elderly.

Keywords: cognitive, elderly, Vietnam, Tai Chi

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Authors: Chun-Fang Hsueh, Chen-Kang Chang

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Introduction: Branched-chain amino acids (BCAA) could reduce cerebral uptake of tryptophan, leading to decreased synthesis of serotonin in the brain. Arginine and citrulline could reduce exercise-induced hyperammonemia by increasing nitric oxide synthesis and the urea cycle. The combination of these supplements could reduce exercise-induced central fatigue. The purpose of this study was to examine the effect of BCAA, arginine, and citrulline supplementation on repeated swimming performance in teenage athletes. Methods: Eight male and eight female high school swimmers ingested 0.085 g/kg BCAA, 0.05 g/kg arginine and 0.05 g/kg citrulline (AA trial) or placebo (PL trial) in a randomized cross-over design. One hour after the ingestion, the subjects performed a 50 m sprint with their best style every 2 min for 8 times in an indoor 25 m pool. The subjects were asked to swim with their maximal effort each time. The time, stroke frequency and stroke length in each sprint were recorded. Venous blood samples were collected before and after the exercise. The time for each sprint was analyzed by 2-way analysis of variance with repeated measurement. Results: When all subjects were pooled together, total time for the AA trial was significantly faster than the PL trial (AA: 244.02 ± 22.94 s; PL: 247.55 ± 24.17 s, p < .001). Individual sprint time showed significant trial (p= .001) and trial x time (p= .004) effects. The post-hoc analysis revealed that the AA trial was significantly faster than the PL trial in the 2nd, 5th, and 6th sprint. In female subjects, there is a significant trial effect (p= .004) with the AA trial being faster in the 1st, 2nd, and 5th sprint. On the other hand, the trial effect was not significant (p= .072) in male subjects. Conclusions: The combined supplementation could improve 8 x 50 m performance in high school swimmers. The blood parameters including BCAA, tryptophan, NH₃, nitric oxide, and urea, as well as the stroke frequency and length in each sprint, are being analyzed. The results will be presented in the conference.

Keywords: central fatigue, hyperammonemia, tryptophan, urea

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Authors: Saeed Abbasi, Davood Farsi, Soudabeh Shafiee Ardestani, Neda Valizadeh

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Objectives: Peripheral vertigo is a common complaint of patients who are visited in emergency departments. In our study, we wanted to evaluate the effect of betahistine as an oral drug vs. intravenous diazepam for the treatment of acute peripheral vertigo. We also wanted to see the possibility of substitution of parenteral drug with an oral one with fewer side effects. Materials and Methods: In this randomized, double-blind study, 101 patients were enrolled in the study. The patients were divided in two groups in a double-blind randomized manner. Group A took oral placebo and 10 mg of intravenous diazepam. Group B received 8mg of oral betahistine and intravenous placebo. Patients’ symptoms and signs (Vertigo severity, Nausea, Vomiting, Nistagmus and Gate) were evaluated after 0, 2, 4, 6 hours by emergency physicians and data were collected by a questionnaire. Results: In both groups, there was significant improvement in vertigo (betahistine group P=0.02 and Diazepam group P=0.03). Analysis showed more improvement in vertigo severity after 4 hours of treatment in betahistine group comparing to diazepam group (P=0.02). Nausea and vomiting were significantly lower in patients receiving diazepam after 2 and 6 hours (P=0.02 & P=0.03).No statistically significant differences were found between the groups in nistagmus, equilibrium & vertigo duration. Conclusion: The results of this randomized trial showed that both drugs had acceptable therapeutic effects in peripheral vertigo, although betahistine was significantly more efficacious after 4 hours of drug intake. As for higher nausea and vomiting in betahistine group, physician should consider these side effects before drug prescription.

Keywords: acute peripheral vertigo, betahistine, diazepam, emergency department

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Authors: Mostafa Solati

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Objectives: Considering the gap of information regarding the optimal antimicrobial efficacy of metronidazole for application in the implant screw hole, this study aimed to compare the antimicrobial efficacy of 0.75% metronidazole and 2% chlorhexidine (CHX) gel applied in the implant screw hole. Materials and Methods: This randomized controlled clinical trial evaluated 60 implants (20 patients, each requiring three implants) in three groups (n=20). In group 1, 0.75% metronidazole gel was applied to the implant screw hole. In group 2, 2% CHX gel was applied, and in group 3, no material was used. Microbial samples were collected from the screw holes after three months, and the microbial colonies were counted. Data were analyzed using ANOVA. Results: The number of bacteria in the control group was significantly higher than that in 0.75% metronidazole gel and 2% CHX groups (P<0.05). The CHX group caused the maximum reduction in colony count with no significant difference from the metronidazole group (P>0.05). Conclusion: The application of 0.75% metronidazole gel and 2% CHX can effectively decrease the colony count in the implant screw hole and can probably play a role in the preservation of peri-implant tissue health.

Keywords: dental implant, metronidazole, CHX, screw hole

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Authors: Najmeh Hamid, Vajiheh Hamedy , Zahra Rostamianasl

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Background: Cancer is one of the medical problems that have been associated with pain. Moreover, the pain is combined with negative emotions such as anxiety, depression and anger. Poor pain management causes negative effects on the quality of life, which results in negative effects that continue a long time after the painful experiences. Objectives: The aim of this research was to compare the effectiveness of Common Cognitive Behavioral Therapy for Pain and its computerized version on the reduction of pain intensity, depression, anger and anxiety in children with cancer. Methods: The research method of this “Randomized Controlled Clinical Trial” was a pre, post-test and follow-up with a control group. In this research, we have examined the effectiveness of Common Cognitive Behavioral Therapy for Pain and its computerized version on the reduction of pain intensity, anxiety, depression and anger in children with cancer in Ahvaz. Two psychological interventions (cognitive behavioral therapy for pain and the computerized version) were compared with the control group. The sample consisted of 60 children aged 8 to 12 years old with different types of cancer at Shafa hospital in Ahwaz. According to the including and excluding criteria such as age, socioeconomic status, clinical diagnostic interview and other criteria, 60 subjects were selected. Then, randomly, 45 subjects were selected. The subjects were randomly divided into three groups of 15 (two experimental and one control group). The research instruments included Spielberger Anxiety Inventory (STAY-2) and International Pain Measurement Scale. The first experimental group received 6 sessions of cognitive-behavioral therapy for 6 weeks, and the second group was subjected to a computerized version of cognitive-behavioral therapy for 6 weeks, but the control group did not receive any interventions. For ethical considerations, a version of computerized cognitive-behavioral therapy was provided to them. After 6 weeks, all three groups were evaluated as post-test and eventually after a one-month follow-up. Results: The findings of this study indicated that both interventions could reduce the negative emotions (pain, anger, anxiety, depression) associated with cancer in children in comparison with a control group (p<0.0001). In addition, there were no significant differences between the two interventions (p<0.01). It means both interventions are useful for reducing the negative effects of pain and enhancing adjustment. Conclusion: we can use CBT in situations in which there is no access to psychologists and psychological services. In addition, it can be a useful alternative to conventional psychological interventions.

Keywords: pain, children, psychological intervention, cancer, anger, anxiety, depression

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Authors: Alireza Vakili, Shahab Ehtesham, Mohsen Danesh Mesgaran, Mahdi Paktinat

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The goal of this study is to determine the chemical compounds of brown Iranian propolis(BIP) extracts and to show flavonoids and phenol effects on nitrogen ammonia (NH3-N) in in vitro. Experimental samples were including two diets with different concentrate: forage ratio (80:20 and 60:40) with eight treatments (1:Control diet 60:40 without BIP,2: 60:40 diet with 25% BIP, 3:60:40 diet with 50% BIP, 4: 60:40 diet with 75% BIP,5: Control diet 80:20 without BIP,6: 80:20 diet with 25% BIP,7: 80:20 diet with 50% BIP and 8: 80:20 diet with 75% BIP) and eight repeats. The trial was analyzed considering a completely randomized design by the GLM procedure of SAS 9.1. Means among treatment were compared by Tukey test. The results of this study showed that in food with 80:20 (concentrate: forage), adding BIP 25% did not statistically change NH3-N (p > 0.05) compared to the control treatment but there was a significant difference (p < 0.05) between the effect of BIP 50% on NH3-N compared to the BIP 25% and the control. In diet with 60:40 (concentrate: forage), there was no significant difference between the effect of BIP 25% on NH3-N and the control, nor was there a significant difference between the effect of BIP 50% and 75%, while a significant difference (p < 0.05) between BIP 50% and 75% and the rest was observed. The propolis extract makes nitrogen ammonia decrease. This may help the nitrogen retain longer in ruminants.

Keywords: brown Iranian propolis, in vitro, nitrogen ammonia, ruminant

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Authors: Brian Moore, Stuart Woodcock, Dean Dudley

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Mental health problems have significant social and economic consequences; however, many individuals do not seek traditional assistance for mental health difficulties. Martial arts training may provide an inexpensive alternative to traditional psychological therapy. While limited research has suggested martial arts training may be an efficacious intervention, the validity and reliability of this are questionable given the small number of relevant studies and other methodological problems. The study examined the effects of 10-week martial arts-based psycho-social intervention which was evaluated using a randomized controlled trial. The intervention was delivered to 283 secondary school students, aged between 12-14 years, who were recruited from government and catholic secondary schools in New South Wales, Australia. The intervention was delivered in a group format onsite at participating schools and had an intervention dose of 10 x 50-60 minute sessions, once per week for 10 weeks. Data were collected at baseline, post-intervention, and 12-week follow-up. Results found a consistent pattern for strength based wellbeing outcomes. All primary and secondary measures relating to resilience and self-efficacy improved for the intervention group and declined for the control group. As these findings were derived from a robust design and rigorous evaluation, they provide valid and reliable evidence that martial arts-based psycho-social interventions can be considered as an efficacious method of improving strength and wellbeing outcomes.

Keywords: martial arts, mental health, resilience, self-efficacy

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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: Mahboobeh Sadeghi, Zahra Izadi Khah, Mansour Hakim Javadi, Masoud Gholamali Lavasani

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Background: Since there is a relation between psychological and physiological factors, the aim of this study was to examine the effect of Emotion Regulation training on cognitive emotion regulation problem in patients with Multiple Sclerosis(MS) Method: In a randomized clinical trial thirty patients diagnosed with Multiple Sclerosis referred to state welfare organization were selected. The sample group was randomized into either an experimental group or a nonintervention control group. The subjects participated in 75-minute treatment sessions held three times a week for 4weeks (12 sessions). All 30 individuals were administered with Cognitive Emotion Regulation questionnaire (CERQ). Participants completed the questionnaire in pretest and post-test. Data obtained from the questionnaire was analyzed using Mancova. Results: Emotion Regulation significantly decreased the Cognitive Emotion Regulation problems patients with Multiple sclerosis (p < 0.001). Conclusions: Emotion Regulation can be used for the treatment of cognitive-emotion regulation problem in Multiple sclerosis.

Keywords: Multiple Sclerosis, cognitive-emotion regulation, emotion regulation, MS

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Authors: Moses Mwangi, Geert Verbeke, Geert Molenberghs

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Cross-over designs are commonly used in randomized clinical trials to estimate efficacy of a new treatment with respect to a reference treatment (placebo or standard). The main advantage of using cross-over design over conventional parallel design is its flexibility, where every subject become its own control, thereby reducing confounding effect. Jones & Kenward, discuss in detail more recent developments in the analysis of cross-over trials. We revisit the simple piecewise linear mixed-effects model, proposed by Mwangi et. al, (in press) for its first application in the analysis of cross-over trials. We compared performance of the proposed piecewise linear mixed-effects model with two commonly cited statistical models namely, (1) Grizzle model; and (2) Jones & Kenward model, used in estimation of the treatment effect, in the analysis of randomized cross-over trial. We estimate two performance measurements (mean square error (MSE) and coverage probability) for the three methods, using data simulated from the proposed piecewise linear mixed-effects model. Piecewise linear mixed-effects model yielded lowest MSE estimates compared to Grizzle and Jones & Kenward models for both small (Nobs=20) and large (Nobs=600) sample sizes. It’s coverage probability were highest compared to Grizzle and Jones & Kenward models for both small and large sample sizes. A piecewise linear mixed-effects model is a better estimator of treatment effect than its two competing estimators (Grizzle and Jones & Kenward models) in the analysis of cross-over trials. The data generating mechanism used in this paper captures two time periods for a simple 2-Treatments x 2-Periods cross-over design. Its application is extendible to more complex cross-over designs with multiple treatments and periods. In addition, it is important to note that, even for single response models, adding more random effects increases the complexity of the model and thus may be difficult or impossible to fit in some cases.

Keywords: Evaluation, Grizzle model, Jones & Kenward model, Performance measures, Simulation

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Authors: Carla Nardelli, Jérome Holtzmann, Céline Baeyens, Catherine Bortolon

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Background. Emotion regulation (ER) is a process associated with difficulties in mental health. Given its transdiagnostic features, its improvement could facilitate the recovery of various psychological issues. A limit of current studies is the lack of knowledge regarding whether available interventionsimprove ER flexibility (i.e., the ability to implement ER strategies in line with contextual demands), even though this capacity has been associated with better mental health and well-being. Therefore, the aim of the study is to test the efficacy of a 9-weeks ER group program (the Affect Regulation Training-ART), using the most appropriate measures (i.e., experience sampling method) in a student population. Plus, the goal of the study is to explore the potential mediative role of ER flexibility on mental health improvement. Method. This Randomized Controlled Trial will comparethe ER program group to an active control group (a relaxation program) in 100 participants. To test the mediative role of ER flexibility on mental health, daily measures will be used before, during, and after the interventions to evaluate the extent to which participants are flexible in their ER. Expected outcomes. Using multilevel analyses, we expect an improvement in anxious-depressive symptomatology for both groups. However, we expect the ART group to improve specifically on ER flexibility ability and the last to be a mediative variable on mental health. Conclusion. This study will enhance knowledge on interventions for students and the impact of interventions on ER flexibility. Also, this research will improve knowledge on ecological measures for assessing the effect of interventions. Overall, this project represents new opportunities to improve ER skills to improve mental health in undergraduate students.

Keywords: emotion regulation flexibility, experience sampling method, psychological intervention, emotion regulation skills

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Authors: Sara Ataei, Molouk Hadjibabaie, Amirhossein Moslehi, Maryam Taghizadeh-Ghehi, Asieh Ashouri, Elham Amini, Kheirollah Gholami, Alireza Hayatshahi, Mohammad Vaezi, Ardeshir Ghavamzadeh

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Acute kidney injury (AKI) is one of the complications of hematopoietic stem cell transplantation and is associated with increased mortality. N-acetylcysteine (NAC) is a thiol compound with antioxidant and vasodilatory properties that has been investigated for the prevention of AKI in several clinical settings. In the present study, we evaluated the effects of intravenous NAC on the prevention of AKI in allogeneic hematopoietic stem cell transplantation patients. A double-blind randomized placebo-controlled trial was conducted, and 80 patients were recruited to receive 100 mg/kg/day NAC or placebo as intermittent intravenous infusion from day -6 to day +15. AKI was determined on the basis of the Risk-Injury-Failure-Loss-Endstage renal disease and AKI Network criteria as the primary outcome. We assessed urine neutrophil gelatinase-associated lipocalin (uNGAL) on days -6, -3, +3, +9, and +15 as the secondary outcome. Moreover, transplant-related outcomes and NAC adverse reactions were evaluated during the study period. Statistical analysis was performed using appropriate parametric and non-parametric methods including Kaplan–Meier for AKI and generalized estimating equation for uNGAL. At the end of the trial, data from 72 patients were analyzed (NAC: 33 patients and placebo: 39 patients). Participants of each group were not different considering baseline characteristics. AKI was observed in 18% of NAC recipients and 15% of placebo group patients, and the occurrence pattern was not significantly different (p = 0.73). Moreover, no significant difference was observed between groups for uNGAL measures (p = 0.10). Transplant-related outcomes were similar for both groups, and all patients had successful engraftment. Three patients did not tolerate NAC because of abdominal pain, shortness of breath and rash with pruritus and were dropped from the intervention group before transplantation. However, the frequency of adverse reactions was not significantly different between groups. In conclusion, our findings could not show any clinical benefits from high-dose NAC particularly for AKI prevention in allogeneic hematopoietic stem cell transplantation patients.

Keywords: acute kidney injury, N-acetylcysteine, hematopoietic stem cell transplantation, urine neutrophil gelatinase-associated lipocalin, randomized controlled trial

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Authors: Zenah Gheblawi, Susan Armijo-Olivo, Elisa B. Pelai, Vaishali Sharma, Musa Tashfeen, Angela Fung, Francisca Claveria

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Due to physiological differences between men and women, pain is experienced differently between the two sexes. Chronic pain disorders, notably temporomandibular disorders (TMDs), disproportionately affect women in diagnosis, and pain severity in opposition of their male counterparts. TMDs are a type of musculoskeletal disorder that target the masticatory muscles, temporalis muscle, and temporomandibular joints, causing considerable orofacial pain which can usually be referred to the neck and back. Therapeutic methods are scarce, and are not TMD-centered, with the latest research suggesting that subjects with chronic musculoskeletal pain disorders have abnormal alterations in the grey matter of their brains which can be remedied with exercise, and thus, decreasing the pain experienced. The aim of the study is to investigate the effects of exercise therapy in TMD female patients experiencing chronic jaw pain and to assess the consequential effects on brain activity. In a randomized controlled trial, the effectiveness of an exercise program to improve brain alterations and clinical outcomes in women with TMD pain will be tested. Women with chronic TMD pain will be randomized to either an intervention arm or a placebo control group. Women in the intervention arm will receive 8 weeks of progressive exercise of motor control training using visual feedback (MCTF) of the cervical muscles, twice per week. Women in the placebo arm will receive innocuous transcutaneous electrical nerve stimulation during 8 weeks as well. The primary outcomes will be changes in 1) pain, measured with the Visual Analogue Scale, 2) brain structure and networks, measured by fractional anisotropy (brain structure) and the blood-oxygen level dependent signal (brain networks). Outcomes will be measured at baseline, after 8 weeks of treatment, and 4 months after treatment ends and will determine effectiveness of MCTF in managing TMD, through improved clinical outcomes. Results will directly inform and guide clinicians in prescribing more effective interventions for women with TMD. This study is underway, and no results are available at this point. The results of this study will have substantial implications on the advancement in understanding the scope of plasticity the brain has in regards with pain, and how it can be used to improve the treatment and pain of women with TMD, and more generally, other musculoskeletal disorders.

Keywords: exercise therapy, musculoskeletal disorders, physical therapy, rehabilitation, tempomandibular disorders

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Authors: Umair Shoukat Ali, Rashna Hoshang Sukhia, Mubassar Fida

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Introduction: The objective of the study was to compare outcomes in terms of Bleeding index (BI), Gingival Index (GI), and Orthodontic Plaque Index (OPI) with video graphics and plaque disclosing tablets (PDT) versus verbal instructions in adult orthodontic patients undergoing fixed appliance treatment (FAT). Materials and Methods: Adult orthodontic patients have recruited from outpatient orthodontic clinics who fulfilled the inclusion criteria and were randomly allocated to three groups i.e., video, PDT, and verbal groups. We included patients undergoing FAT for six months of both genders with all teeth bonded mesial to first molars having no co-morbid conditions such as rheumatic fever and diabetes mellitus. Subjects who had gingivitis as assessed by Bleeding Index (BI), Gingival Index (GI), and Orthodontic Plaque Index (OPI) were recruited. We excluded subjects having > 2 mm of clinical attachment loss, pregnant and lactating females, any history of periodontal therapy within the last six months, and any consumption of antibiotics or anti-inflammatory drugs within the last one month. Pre- and post-interventional measurements were taken at two intervals only for BI, GI, and OPI. The primary outcome of this trial was to evaluate the mean change in the BI, GI, and OPI in the three study groups. A computer-generated randomization list was used to allocate subjects to one of the three study groups using a random permuted block sampling of 6 and 9 to randomize the samples. No blinding of the investigator or the participants was performed. Results: A total of 99 subjects were assessed for eligibility, out of which 96 participants were randomized as three of the participants declined to be part of this trial. This resulted in an equal number of participants (32) that were analyzed in all three groups. The mean change in the oral hygiene indices score was assessed, and we found no statistically significant difference among the three interventional groups. Pre- and post-interventional results showed statistically significant improvement in the oral hygiene indices for the video and PDT groups. No statistically significant difference for age, gender, and education level on oral hygiene indices were found. Simple linear regression showed that the video group produced significantly higher mean OPI change as compared to other groups. No harm was observed during the trial. Conclusions: Visual aids performed better as compared to the verbal group. Gender, age, and education level had no statistically significant impact on the oral hygiene indices. Longer follow-ups will be required to see the long-term effects of these interventions. Trial Registration: NCT04386421 Funding: Aga Khan University and Hospital (URC 183022)

Keywords: oral hygiene, orthodontic treatment, adults, randomized clinical trial

Procedia PDF Downloads 88

Authors: K. O. Ogbedeh, C. P. Ekwe, G. O. Ihejirika, S. A. Dialoke, O. P. Onyewuchi, C. P. Anyanwu, I. E. Kalu

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As one of the major pests of field crops, termites attack groundnut at all stages of its development, especially during prolonged dry spell. Effect of palm bunch ash and neem(Azardirachta indica A. Juss) leaf powder on termite infestation in groundnut field in Owerri, Nigeria was investigated in this study. The field trial was carried out in 2016 at the Teaching and Research Farm of the Federal University of Technology, Owerri, Nigeria. The experiment was laid out in a 3x3 Factorial fitted into a Randomized Complete Block Design (RCBD) with three replications. The treatments include three rates of palm bunch ash at 0.0 (control), 1.0 and 2.0tons/ha and three rates of neem leaf powder at 0.0(control), 1.0, 2.0 tons/ha respectively. Data were collected on percentage emergence, termite incidence and termite severity. These were subjected to analysis of variance (ANOVA), and means were separated using least significant difference at 5% level of probability. The result shows that there were no significant (P= 0.05) differences in percentage emergence amongst treatment means due to palm bunch ash and neem leaf powder applications. Contrarily, palm bunch ash at 2.0 tons/ha recorded the least termite incidence especially at twelve weeks after planting (12WAP) with a value of 22.20% while control plot maintained highest values at 6WAP (48.70%) and 12WAP (48.30%) respectively. Also palm bunch ash at 2.0tons/ha depressed termite severity more than other treatments especially at 2 and 4 WAP (0.56) respectively. Control plots on the other hand consistently maintained highest termite severity throughout the trial with the highest value at 2 and 12WAP (1.56). Conclusively, palm bunch ash exhibited highest depressive action against termite on groundnut especially at higher application value (2.0tons/ha).

Keywords: groundnut, incidence, neem, palm, severity, termites

Procedia PDF Downloads 202

Authors: Tobias Stephan Kaeding, Rebecca Schwarz, Momme Kück, Lothar Stein

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Introduction: The goal of this randomized and controlled study is to examine whether whole-body vibration (WBV) training is able to reduce self-reported physical disability in office employees with chronic low-back pain. Materials and methods: 41 subjects (68.3% female/mean age 45.5 ± 9.1 years/mean BMI 26.6 ± 5.2) were randomly allocated to an intervention group (INT (n= 21)) or a control group (CON (n=20). The INT participated in WBV training 2.5 times per week for 3 months. The primary outcome was the change in the Roland and Morris disability questionnaire (RMQ) score over the study period. In addition, secondary outcomes included changes in the Oswestry Disability Index (ODI). Results: The compliance with the intervention in the INT reached a mean of 81.1% ± 31.2% with no long-lasting unwanted side effects. We found significant positive effects of 3 months of WBV training in the INT compared to the CON regarding the RMQ (p=0.027) and the ODI (p=0.002). Conclusions: WBV training seems to be an effective, safe and suitable intervention for the reduction of the self-reported physical disability in seated working employees with chronic low-back pain.

Keywords: back pain, exercise, occupational health management, vibration training

Procedia PDF Downloads 271

Authors: Teagan Fink, Lynn Chong, Michael Hii, Brett Knowles

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Background: Telemedicine is a rapidly advancing field providing healthcare to patients at a distance from their treating clinician. There is a paucity of high-quality evidence detailing the safety and acceptability of telemedicine for postoperative outpatient follow-up. This randomized controlled trial – conducted prior to the COVID 19 pandemic – aimed to assess patient satisfaction and safety (as determined by readmission, reoperation and complication rates) of telephone compared to face-to-face clinic follow-up after uncomplicated general surgical procedures. Methods: Patients following uncomplicated laparoscopic appendicectomy or cholecystectomy and laparoscopic or open umbilical or inguinal hernia repairs were randomized to a telephone or face-to-face outpatient clinic follow-up. Data points including patient demographics, perioperative details and postoperative outcomes (eg. wound healing complications, pain scores, unplanned readmission to hospital and return to daily activities) were compared between groups. Patients also completed a Likert patient satisfaction survey following their consultation. Results: 103 patients were recruited over a 12-month period (21 laparoscopic appendicectomies, 65 laparoscopic cholecystectomies, nine open umbilical hernia repairs, six laparoscopic inguinal hernia repairs and two laparoscopic umbilical hernia repairs). Baseline patient demographics and operative interventions were the same in both groups. Patient or clinician-reported concerns on postoperative pain, use of analgesia, wound healing complications and return to daily activities at clinic follow-up were not significantly different between the two groups. Of the 58 patients randomized to the telemedicine arm, 40% reported high and 60% reported very high patient satisfaction. Telemedicine clinic mean consultation times were significantly shorter than face-to-face consultation times (telemedicine 10.3 +/- 7.2 minutes, face-to-face 19.2 +/- 23.8 minutes, p-value = 0.014). Rates of failing to attend clinic were not significantly different (telemedicine 3%, control 6%). There was no increased rate of postoperative complications in patients followed up by telemedicine compared to in-person. There were no unplanned readmissions, return to theatre, or mortalities in this study. Conclusion: Telemedicine follow-up of patients undergoing uncomplicated general surgery is safe and does not result in any missed diagnosis or higher rates of complications. Telemedicine provides high patient satisfaction and steps to implement this modality in inpatient care should be undertaken.

Keywords: general surgery, telemedicine, patient satisfaction, patient safety

Procedia PDF Downloads 92

Authors: Xinli Chi, Xiaoqi Wei

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Background: Body-mind theory refers to the concept that the mind and body are interconnected; in this case, combining aerobic exercise and mindfulness-based training may be beneficial for mind-body health; however, there is limited evidence regarding their effects and potential mechanisms among Chinese university students. Therefore, the current study aims to examine the preliminary effects and feasibility of the combined intervention on depressive and insomnia symptoms, as well as to explore the underlying mechanisms. Methods: This is a two-arm pilot study of a randomized, controlled trial. Sixty-one Chinese university students were randomly allocated to 8-week combined intervention group (aerobic exercise plus mindfulness, N = 36) or control group (N = 36). In addition, 8 participants in combined intervention group were later volunteer to engage in semi-structured interview. The Self-Rating Depression Scale (SDS) and the Youth Self-Rating Insomnia Scales (YSIS) were used to measure depressive and insomnia symptoms, respectively. The intervention outcome and feasibility were tested by repeated-measures ANOVA, mediation model, and qualitative analysis. Results: The study included 31 participants in the intervention group and 30 participants in the control group, all of whom completed pre-test and post-test questionnaires. The results of the repeated-measures ANOVA showed that the combined intervention was effective in reducing depressive and insomnia symptoms among university students. Moreover, the mediation analysis suggested that improvement in insomnia symptoms might be a significant mechanism for the combined intervention. Qualitative analysis identified two main themes: “Helpful aspects of mind-body state” (including 7 sub-themes) and “Factors that influence the training effects” (including 3 sub-themes). Conclusions: The study confirmed the preliminary effect and feasibility of the combined intervention of mindfulness and aerobic exercise, while also exploring the potential mechanisms underlying this effect. Additionally, qualitative data provided valuable insights for optimizing future protocols.

Keywords: combined intervention, mindfulness, aerobic exercise, depressive symptoms, insomnia symptoms

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Authors: Sopana Wongtawee

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Purpose: Adequate bowel cleansing is essential for a high quality, effective and safe colonoscopy. The aims of this study were to compare the efficacy of bowel preparation based on a low-residue diet before 8:00 followed by a clear-liquid diet, and a low-residue diet until 16:00 one day before colonoscopy using sodium phosphate solution (Xubil ®), the side effects of the two protocols and the patient satisfaction with them. Method: This was an endoscopist-blinded, prospective, randomized, controlled trial. A total of 224 patients (112 in each group) scheduled for outpatient colonoscopy met the criteria.They were randomized to either a low-residue diet consisting of white rice porridge with either fish, chicken or eggs before 8:00 followed by a clear-liquid diet (Group 1) or a low-residue diet consisting of the same food and drink, until 16:00 the day before colonoscopy(Group 2). All of them received 45 ml of sodium phosphate solution (Xubil ®) and three glasses of water (300 ml/glass) the evening before and the morning of the procedure. The cleansing efficacy of bowel preparation was rated according to the modified Rajawithi hospital bowel preparation score scale, patient satisfaction with bowel preparation was rated using Likert scale, and side effects of the 2 protocols was assessed using a patient questionnaire. Results: The cleansing efficacy between the two groups was significantly different (p=0.02). Satisfaction with bowel preparation and side effects were not different, except for the feeling of hunger in the first group (p=0.001). Conclusion: The low-residue diet consisting of white rice porridge with fish, chicken or eggs until 16:00 one day before colonoscopy achieved a better bowel-cleansing efficacy than the protocol consisting of clear liquid all day and rice porridge only before 8:00 one day before colonoscopy.

Keywords: bowel preparation, colonoscopy, sodium phosphate solution, nursing management

Procedia PDF Downloads 358

Authors: Ali Faisal Saleem, Farheen Quadri, Mach Ondrej, Anita Zaidi

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Purpose: Pakistan is the final frontier for a polio-free world. Chronic malnutrition is associated with lack of effective gut immunity, and possibly associated with poliomyelitis in children received multiple OPV. We evaluate IPV dose administered together with OPV results in higher immunogenicity and mucosal immunity compared to OPV alone in chronically malnourished infants. Methods AND Materials: A community-based, unblinded-randomized-trial, conducted in 5 peri-urban, low-middle-income households of Karachi, in infants 9-12 months. Two study groups were non-malnourished (HAZ= -2 or more) and chronic malnourished (HAZ <-2SD), with 2-arms each i) OPV and ii) OPV and IPV. Two blood specimens (2ml) at baseline and at day 28 and two stool specimens (6 gm.) at day 29 and after 7 days. All infants received a bOPV challenge dose after first stool specimen. Calculates sample size was 210 in each arm. Serological (baseline compared to 28 days post-vaccine) and mucosal immunity after one week of bOPV challenge dose were study outcomes. Results: Baseline seroprevalence in malnourished infants were low compared to non-malnourished (P1, P2 and P3 (p=<0.001). There is significant rise in antibody titer and P1 seroprevalence in Mal A and B after receiving study vaccine; much higher in Mal B. Infants randomized to bOPV + IPV study vaccine showed incremental immune response against P1 (Mal B, 92.2%; Nor B, 98.4%), P2 (Mal B, 90.4%; Nor B, 94.7%), and P3 (Mal B, 85.6% and Nor B, 93.5%) was observed. A significant proportion of infants in malnourished (P1, 13%; P2, 24%; P3, 26%) and normally nourished group (P1, 5%; P2, 11%; P3, 14%) were found to be seronegative at baseline. Infants who received BOPV + IPV as their study vaccine showed a very high seroconversion response after vaccine (p=<0.001 for P1, P2 and P3). Majority of the specimens were negative at baseline (Mal A, 2%, Mal B, 1%; Nor A, 2%; Nor B, 1%), and remains negative after bOPV challenge dose (Mal A, 8%, Mal B, 6%; Nor A, 11%; Nor B, 10%). Conclusion: Malnourished-infants have low poliovirus-seroprevalence that increased remarkably after IPV. There is less viral shedding after IPV in infants.

Keywords: chronic malnutrition, infants, IPV, OPV

Procedia PDF Downloads 372

Authors: Ahmed Torad

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Background: Knee osteoarthritis (OA) is a prevalent musculoskeletal condition characterized by pain and functional impairment. While various rehabilitation approaches have been employed, the effectiveness of high-intensity interval training (HIIT) compared to traditional rehabilitation exercises remains unclear. Objective: This randomized controlled trial aimed to compare the effects of HIIT and traditional rehabilitation exercises on pain reduction, functional improvement, and quality of life in individuals with knee OA. Methods: A total of 120 participants diagnosed with knee OA were randomly allocated into two groups: the HIIT group (n=60) and the traditional rehabilitation group (n=60). The HIIT group participated in a 12-week supervised program consisting of high-intensity interval exercises, while the traditional rehabilitation group followed a conventional physiotherapy regimen. Outcome measures included visual analog scale (VAS) pain scores, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the Short Form-36 Health Survey (SF-36) at baseline and after the intervention period. Results: Both groups showed significant improvements in pain scores, functional outcomes (WOMAC), and quality of life (SF-36) after 12 weeks of intervention. However, the HIIT group demonstrated superior pain reduction (p<0.001), functional improvement (p<0.001), and physical health-related quality of life (p=0.002) compared to the traditional rehabilitation group. No significant differences were observed in mental health-related quality of life between the two groups. Conclusion: High-intensity interval training appears to be a more effective rehabilitation approach than traditional exercises for individuals with knee osteoarthritis, resulting in greater pain reduction, improved function, and enhanced physical health-related quality of life. These findings suggest that HIIT may represent a promising intervention strategy for managing knee OA and enhancing the overall well-being of affected individuals.

Keywords: knee osteoarthritis, high-intensity interval training, traditional rehabilitation exercises, randomized controlled trial, pain reduction, functional improvement, quality of life

Procedia PDF Downloads 33

Authors: T. Goldstein, E. Serok, J. D. Kark

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Background and Aim: The prevalence of obesity is increasing worldwide and in Israel. To meet this challenge, our study tests a new educational approach through a controlled school-based trial to achieve an improvement in eating habits, aerobic activity, and reduced obesity in Grades 2-3. Methods and Design: A cluster randomized controlled trial allocated 4 elementary schools (3rd and 2nd-grade classes each) to intervention or control groups. This allocation was switched with the next cohort of children. Recruitment was in first grade, randomization at the beginning of second grade, evaluation of results at the end of second grade and the beginning of third grade — intervention: 5 joint parent-children classroom activities on health topics and 5 educational workshops for parents only. Alfred Adler's concepts were guiding principles. Subjects: Of 743 children in 23-second grade classes, parents provided informed consent for 508 (68%). Information of retention health habits continued for third grade. Additional parental approvals were required. Parents provided informed consent for third-grade follow-up for 432. Results: At the end of 2nd grade, the amount of aerobic activity increased in the intervention group in comparison with the control group, the difference being marginally statistically significant (p=0.061). There is a significant difference between the groups in the percentage of "no activity being done" reported at the end of second grade when in the experimental group, the percentage is lower than the control. There are differences between genders in the percentage of aerobic activity at the end of second grade (p=0.044) and in the third grade (p < 0.0001). Height increased significantly (p=0.030 ), and waist circumference declined significantly (p=0.021) in the intervention compared with the control group. There were no significant between-group differences in BMI and weight. Conclusion: There were encouraging changes in aerobic activity and in anthropometric measurements. To maintain changes over longer periods, refreshing these nutrition and activity themes annually in school using the model is required.

Keywords: aerobic activity, child obesity, Alfred Adler, schoolchildren

Procedia PDF Downloads 119

Authors: Che Jusoh, Mohd Rahimi, Toby Mundel

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This study was designed to investigate the physiological and performance effects of a local Malaysian native starch (Metroxylin sago) on cycling in a hot (30°C) and humid (78% RH) environment. Eight male, non-heat acclimated, well-trained club cyclists (VO2max 65 ± 10 ml kg-1 min-1, peak aerobic power 397 ± 71 W) completed one familiarization and three experimental trials in our laboratory simulating cycling in environmental conditions of heat and humidity. Each trial consisted of 45 minutes at a fixed workload (55% VO2max) followed by a 15 minute time-trial (~75% VO2max). Sago in porridge form was consumed 1h before exercise (Pre), in gel form during exercise (Dur) and compared to a control trial (Con), using a random, cross-over design. Plasma glucose concentration did not differ between trials (P = 0.06) with an increase from 4.1 ± 0.6 to 6.1 ± 1.6 mmol-1 (Con), 4.8 ± 1.7 to 5.7 ± 0.4 mmol-1 (Pre) and 4.7 ± 0.8 to 6.9 ± 1.4 mmol-1 (Dur) from start to end of exercise. Plasma lactate increased (P = 0.02) from 1.6 ± 0.3 to 7.6 ± 2.2 mmol-1 (Con), 1.7 ± 0.5 to 7.3 ± 2.9 mmol-1 (Pre) and 1.6 ± 0.2 to 7.3 ± 1.8 mmol-1 (Dur) with no effect of trial (P = 0.74). No differences were found between trials for RER (P = 0.328) with values of 0.93 ± 0.05 (Con), 0.94 ± 0.04 (Pre) and 0.92 ± 0.04 (Dur). There were no differences between trials in rectal (P = 0.64) and skin (P = 0.56) temperatures; values reaching 39.1 ± 0.5°C (Con), 38.9 ± 0.4°C (Pre) and 39.1 ± 0.4°C (Dur) for rectal and 32.7 ± 1.2°C (Con), 32.8 ± 1.4°C (Pre) and 32.8 ± 1.8°C (Dur) for skin temperature, respectively. Heart rate (P = 0.07) also did not differ between trials but reached maximal values by the end of time-trial for all trials. Performance was unaffected by trial (P = 0.98) with the average work completed in 15 minutes being 221 ± 33 kJ (Con), 222 ± 31 kJ (Pre) and 219 ± 32 kJ (Dur), respectively. Therefore, the results of this investigation do not support consumption of sago, either before or during exercise, in altering the thermoregulatory, metabolic or performance responses in a hot and humid environment.

Keywords: hot and humid, physiology, time trial performance, thermoregulatory

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Authors: Maryam Rafraf, Aida Ghaffari

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Objectives: Nonalcoholic fatty liver disease (NAFLD) is considered as an independent risk factor for cardiovascular disease (CVD). Dyslipidemia contributes to the enhanced risk of CVD in persons with NAFLD. This study aimed to investigate the effects of turmeric supplementation on serum lipids levels in patients with NAFLD. Methods: In this double-blind, randomized, controlled clinical trial, 46 NAFLD patients (21 males and 25 females; age range, 20 – 60 years) were randomly assigned in the two groups. The intervention and control groups received 3g of turmeric (n = 23) and placebo (n = 23), daily for 12 weeks. Fasting blood samples were collected at baseline and at the end of the trial. Results: Turmeric supplementation significantly increased serum levels of HDL-C compared with the placebo group at the end of the study (by 12.73%, P < 0.05). Serum levels of triglyceride, total cholesterol, and low-density lipoprotein cholesterol were significantly reduced within turmeric group at the end of the study (P < 0.05). Conclusions: Turmeric consumption had beneficial effects on serum lipids levels of subjects and may be useful in controlling of CVD risk factors in NAFLD patients.

Keywords: nonalcoholic fatty liver, serum lipids, supplementation, turmeric

Procedia PDF Downloads 122