Effect of Pilates Exercises on Patients With Irritable Bowel Syndrome

NCT05832801 | Completed

• 1 other identifier: P.T.REC/012/004218
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Irritable bowel syndrome symptom severity

  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

  (at baseline and after 8 weeks)

Secondary Outcomes (4)

• number of Bowel movement

  (at baseline and after 8 weeks)

• Anxiety and depression

  (at baseline and after 8 weeks)

• Fatigue

  (at baseline and after 8 weeks)

• body weight

  (at baseline and after 8 weeks)

Study Arms (2)

Group ( Traditional dietary advice)

OTHER

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

Other: ( Traditional dietary advice )

Group (Pilates and traditional dietary advice )

EXPERIMENTAL

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 .

Other: ( Traditional dietary advice ); Other: (Pilates exercises)

Interventions

( Traditional dietary advice ) 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 ( Traditional dietary advice); Group (Pilates and traditional dietary advice )

(Pilates exercises) 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

Group (Pilates and traditional dietary advice )

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

faculty of physical therapy, Cairo university

Giza, 11432, Egypt

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Therapeutics

Study Officials

• Heba A. Abd El Ghafar, A. Professor

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Model Details: 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.

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: April 27, 2023
• Study Start: July 1, 2023
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: July 8, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)