Effect of Pilates Exercises on Patients With Irritable Bowel Syndrome

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Other: ( Traditional dietary advice ); Other: (Pilates exercises)

• Registration Number: NCT05832801
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study First Submitted: 2023-03-29
• Study First Submitted QC: 2023-04-15
• Study First Posted: 2023-04-27
• Study Start: 2023-07-01
• Primary Completion: 2024-02-28
• Study Completion: 2024-02-28
• Status Verified: 2024-06
• Last Update Submitted: 2024-07-03
• Last Update Posted: 2024-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group (Pilates and traditional dietary advice )	( Traditional dietary advice )	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. Warming up and cooling down stretches for 5 minutes will be done before and after exercise .
Group ( Traditional dietary advice)	( Traditional dietary advice )	Each patient will follow traditional dietary advice only for 2 months.
Group (Pilates and traditional dietary advice )	(Pilates exercises)	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. Warming up and cooling down stretches for 5 minutes will be done before and after exercise .

Primary Outcome Measures

Name	Time	Method
Irritable bowel syndrome symptom severity	(at baseline and after 8 weeks)	BS-SSS is a patient-based scale that assesses 5 clinically relevant items during a 10-day period: (1) severity of abdominal pain, (2) frequency of abdominal pain, (3) severity of abdominal distention or tightness, (4) dissatisfaction with bowel habits, and (5) interference of IBS with life in general. Each item is scored on a visual analogue scale (VAS) from 0 to 100, yielding overall scores ranging from 0 to 500 (a higher score indicates worse condition). A reduction of 50 in the IBS-score is adequate to detect a clinical improvement

Secondary Outcome Measures

Name	Time	Method
number of Bowel movement	(at baseline and after 8 weeks)	Bristol stool form scale will be used to record bowel movements. The patients will record all bowel movements and its consistency The scale ranges from 1 to 7, where type 1 and 2 is hard and lumpy stools and type 6 and 7 is loose and watery stools
body weight	(at baseline and after 8 weeks)	weight height scale used to assess body weight
Fatigue	(at baseline and after 8 weeks)	modified Fatigue Impact Scale, a multidimensional scale developed to assess the perceived impact of fatigue on a variety of daily activities. These scores are designed to measure the disability associated with fatigue (the extent to which fatigue limits activities), not the severity of symptoms. MFIS total score ranges from 0 to 20, with the following ranges reflecting how often the person is limited in activities by fatigue: 0 -5 (never), 6 -9 (rarely), 10-14 (sometimes), 15-19 (often) and 20 (almost always).
Anxiety and depression	(at baseline and after 8 weeks)	Hospital Anxiety and Depression Scale(HADS), the HADS includes 14 items assessing anxiety (7-item) and depression (7-item), which are rated on a 4-point Likert-type (from 0 to 3).A score of 0-7 is considered as normal, 8-10 as a borderline case, and 11-21 as a case (anxiety or depression)

Trial Locations

Locations (1)

faculty of physical therapy, Cairo university; 🇪🇬 Giza, Egypt