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Clinical Trial Summary

purpose: to investigate the effect of pilates exercises on patients with irritable bowel syndrome. Methods sixty patients with IBS will be recruited and randomly assigned into two groups, group A and group B. Patients in both groups will receive a traditional dietary advice for IBS, but group A will receive additional pilates exercises. All patients will be evaluated pre and post treatment for Laboratory investigation for (TNFα and MDA),Bristol stool form , Irritable bowel syndrome symptoms , anxiety and depression and Fatigue.


Clinical Trial Description

A) Procedures for evaluation: The practical section of the study will be undertaken in 2months (2 sessions a week). Measurement will be taken before the start of treatment program then after the end of 2 months of treatment program in the following manner: 1. Laboratory investigations for TNFα and MDA: Blood samples will be collected after an 8-12 h overnight fasting. For each sample, 5 mL of blood will be drawn. Serums will be frozen at -20 °C immediately and then stored at -80 °C until further laboratory analyses were carried out. 2. Bristol stool form scale: The patients will record all bowel movements and its consistency 3. Irritable bowel syndrome symptom severity score (IBS-SSS) will be used to measure severity of IBS symptoms 4. The hospital anxiety and depression scale will be used to assess depression and anxiety 5. Modified Fatigue Impact scale (MFIS): was developed to assess the perceived impact of fatigue on a variety of daily activities. 6. weight height scale for assessing BMI B-Treatment procedures: All patients in both groups will be instructed to follow traditional dietary advice for IBS which is based on guidance provided by the National Institute for Health and Care Excellence (NICE ) and the British Dietetic Association (BDA). . Group (A) Patients in this group will participate in 2 months Pilates exercise program, 2 times per week for 16 sessions, and will follow traditional dietary advice for IBS. Warming up and cooling down stretches for 5 minutes will be done before and after exercise Group (B) Each patient will follow traditional dietary advice for IBS which is based on guidance provided by the National Institute for Health and Care Excellence (NICE ) and the British Dietetic Association (BDA). C)Data analysis: Statistical analysis will be performed through the statistical package for social studies (SPSS) version 24 for windows. Descriptive statistics will be conducted to describe the data. Mixed-Model ANOVA will be used to determine the within-group changes and the between-group difference. The level of significance for all statistical tests will be set at p<0.05. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05832801
Study type Interventional
Source Cairo University
Contact
Status Completed
Phase N/A
Start date July 1, 2023
Completion date February 28, 2024

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