Effect of Pilates Exercises on Patients With Irritable Bowel Syndrome

NCT ID: NCT05832801

Last Updated: 2024-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2024-02-28

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.

Conditions

Irritable Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group ( Traditional dietary advice)

Each patient will follow traditional dietary advice only for 2 months.

Group Type: OTHER

( Traditional dietary advice )

Intervention Type: OTHER

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). Its principles include adopting healthy, sensible eating patterns such as having regular meals, never eating too little/too much, maintaining adequate hydration, and reducing the intake of (1) alcohol/caffeine/fizzy drinks, (2) fatty/spicy/processed foods, (3) fresh fruit to a maximum of 3 per day, (4) fiber and other commonly consumed gas-producing foods (eg, beans, bread, sweeteners, etc), and (5) addressing any perceived food intolerances (eg, dairy).

Group (Pilates and 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 Type: EXPERIMENTAL

( Traditional dietary advice )

Intervention Type: OTHER

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). Its principles include adopting healthy, sensible eating patterns such as having regular meals, never eating too little/too much, maintaining adequate hydration, and reducing the intake of (1) alcohol/caffeine/fizzy drinks, (2) fatty/spicy/processed foods, (3) fresh fruit to a maximum of 3 per day, (4) fiber and other commonly consumed gas-producing foods (eg, beans, bread, sweeteners, etc), and (5) addressing any perceived food intolerances (eg, dairy).

(Pilates exercises)

Intervention Type: OTHER

Pilates exercises will be in the form of Swan, One leg up-down, Leg circles, Single leg stretch, Saw, Side kicks, The hundred,. Pelvic lift on the ball, Sit-ups with the ball, Stretching on the ball. exercise Dose will be First month (first- eighth session) composed of one set of eight repetitions Second month (eighth-sixteenth session) composed of two sets of ten repetitions

Interventions

( Traditional dietary advice )

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). Its principles include adopting healthy, sensible eating patterns such as having regular meals, never eating too little/too much, maintaining adequate hydration, and reducing the intake of (1) alcohol/caffeine/fizzy drinks, (2) fatty/spicy/processed foods, (3) fresh fruit to a maximum of 3 per day, (4) fiber and other commonly consumed gas-producing foods (eg, beans, bread, sweeteners, etc), and (5) addressing any perceived food intolerances (eg, dairy).

Intervention Type: OTHER

(Pilates exercises)

Pilates exercises will be in the form of Swan, One leg up-down, Leg circles, Single leg stretch, Saw, Side kicks, The hundred,. Pelvic lift on the ball, Sit-ups with the ball, Stretching on the ball. exercise Dose will be First month (first- eighth session) composed of one set of eight repetitions Second month (eighth-sixteenth session) composed of two sets of ten repetitions

Intervention Type: OTHER

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 -

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Doaa Mohammed Mahmoud Allam

assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Heba A. Abd El Ghafar, A. Professor

Role: STUDY_DIRECTOR

Cairo University

Locations

faculty of physical therapy, Cairo university

Giza, , Egypt

Countries

Egypt

Other Identifiers

P.T.REC/012/004218

Identifier Type: -

Identifier Source: org_study_id