Clinical trial NCT05832801: Effect of Pilates Exercises on Patients With Irritable Bowel Syndrome
Official title: Effect of Pilates Exercises on Symptom Severity in Patients With Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-04-27
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be 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.
Primary purpose: TREATMENT

Brief 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 irritable bowel syndrome symptom severity, number of bowel movements , anxiety and depression , Fatigue and body weight.

Detailed 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. -Irritable bowel syndrome symptom severity score (IBS-SSS) will be used to measure severity of IBS symptoms
2. number of bowel movements per week will be recorded
3. The hospital anxiety and depression scale will be used to assess depression and anxiety
4. Modified Fatigue Impact scale (MFIS): was developed to assess the perceived impact of fatigue on a variety of daily activities.
5. 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.

Eligibility criteria: Inclusion Criteria:

1. They will be under medical supervision.
2. Age between 20 to 45 years.).
3. Ability to perform exercises.
4. Diagnosis of IBS will be based on Rome IV Diagnostic criteria.
5. Baseline irritable bowel syndrome severity score \>174
6. over weight or grade one obese IBS patients who diagnosed as constipation predominant IBS according to Bristol stool scale.

Exclusion Criteria:

1. Organic gastrointestinal disorders or other organic disease hindering physical activity.
2. Treatment with steroids, immunosuppressants for at least 6 months before the beginning of the study.
3. A history of resection of the stomach, small intestine, or large intestine .
4. Concurrent infectious enteritis, hyperthyroidism, hypothyroidism, or other diseases that may affect gastrointestinal transit or colonic function.
5. History or current evidence of abuse of drugs or alcohol within the previous year.
6. Malignant tumors.
7. Concurrent serious cardiovascular, respiratory, renal, hepatic, gastrointestinal (excluding IBS).
8. Fibromyalgia and pregnancy -

Primary outcomes:
measure: Irritable bowel syndrome symptom severity
timeFrame: (at baseline and after 8 weeks)
Secondary outcomes:
measure: number of Bowel movement
timeFrame: (at baseline and after 8 weeks)
measure: Anxiety and depression
timeFrame: (at baseline and after 8 weeks)
measure: Fatigue
timeFrame: (at baseline and after 8 weeks)
measure: body weight
timeFrame: (at baseline and after 8 weeks)
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: faculty of physical therapy, Cairo university
Study officials:
affiliation: Cairo University
name: Heba A. Abd El Ghafar, A. Professor
role: STUDY_DIRECTOR
References: