Irritable Bowel Syndrome Clinical Trial
Official title:
Effect of Pilates Exercises on Selected Inflammatory and Oxidative Stress Biomarkers in Patients With Irritable Bowel Syndrome
Verified date | June 2024 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 - |
Country | Name | City | State |
---|---|---|---|
Egypt | faculty of physical therapy, Cairo university | Giza |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
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) |
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