Effect of Pilates Exercises on Patients With Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

Official title:

Effect of Pilates Exercises on Selected Inflammatory and Oxidative Stress Biomarkers in Patients With Irritable Bowel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05832801
• Other study ID #: P.T.REC/012/004218
• Status: Completed
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: February 28, 2024

Study information

• Verified date: June 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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, antibiotics, 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 (excluding hernia repair, appendectomy (> 3 months) or resection of benign polyps).

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 -

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Other:
• ( 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).
• (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

Locations

Country	Name	City	State
Egypt	faculty of physical therapy, Cairo university	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of selected inflammatory biomarker level (tumor necrosis factor alpha )	Serum levels of tumor necrosis factor alpha (TNFa) will be measured using an enzyme-linked immunosorbent assay (ELISA)	(change from baseline TNFa level at 8 weeks)
Primary	change of oxidative stress level (malondialdehyde MDA )	Tiobarbituric acid method will be used for measuring serum malondialdehyde (MDA) level	(change from baseline MDA level at 8 weeks)
Secondary	number of Bowel movement	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	(at baseline and after 8 weeks)
Secondary	Irritable bowel syndrome symptom severity	IBS-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	Anxiety and depression	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)	(at baseline and after 8 weeks)
Secondary	Fatigue	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).	(at baseline and after 8 weeks)
Secondary	body weight	weight height scale used to assess body weight	(at baseline and after 8 weeks)