Effect of Pilates Exercises on Patients With Irritable Bowel Syndrome

Study Overview
=================
Brief Summary
-----------------
purpose: to investigate the effect of pilates exercises on patients with irritable bowel syndrome. Methods fifty 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 ,quality of life, anxiety and depression and Fatigue.

Detailed Description
-----------------
A) Procedures for evaluation: The practical section of the study will be undertaken in 8 weeks (2 sessions a week). Measurement will be taken before the start of treatment program then after the end of 8 weeks treatment program in the following manner: 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. Bristol stool form scale: The patients will record all bowel movements and its consistency Irritable bowel syndrome symptom severity score (IBS-SSS) will be used to measure severity of IBS symptoms The hospital anxiety and depression scale will be used to assess depression and anxiety IBS-quality of life (IBS-QOL): will be used to assess QOL impairment in IBS. Modified Fatigue Impact scale (MFIS): was developed to assess the perceived impact of fatigue on a variety of daily activities. 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 an 8-week 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 considered before and after exercise for the safety of the patients. 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.

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

Conditions
-----------------
Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Other: ( Traditional dietary advice )
* Other: (Pilates exercises)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 (moderate to severe)>174 Exclusion Criteria: Organic gastrointestinal disorders or other organic disease hindering physical activity. Treatment with steroids, antibiotics, immunosuppressants for at least 6 months before the beginning of the study. A history of resection of the stomach, small intestine, or large intestine (excluding hernia repair, appendectomy (> 3 months) or resection of benign polyps). 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 -

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group ( Traditional dietary advice)<br>Each patient will follow traditional dietary advice only for 8 weeks. Compliance of the patient to the diet will be assessed using regular telephone calls. | Other: ( Traditional dietary advice )<br>* 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).<br>|
| Experimental: Group (Pilates and traditional dietary advice )<br>Patients in this group will participate in an 8-week 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 considered before and after exercise for the safety of the patients. | Other: ( Traditional dietary advice )<br>* 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).<br>Other: (Pilates exercises)<br>* 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 (1st-8th session) 1 set of 8 repetitions Second month (8th-16th session) 2 sets of 10 repetitions<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of selected inflammatory biomarker level (tumor necrosis factor alpha ) | Serum levels of tumor necrosis factor alpha (TNFα) will be measured using an enzyme-linked immunosorbent assay (ELISA) | (change from baseline TNFα level at 8 weeks) | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bowel movement and consistency | 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) | 
| 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) | 
| 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) | 
| IBS-quality of life ( | IBS-quality of life questionnaire as a 34-items instrument was also developed and validated to assess QOL impairment in IBS. Each item is rated on a 5-point Likert scale (1 = not at all, 2 = slightly, 3 = moderately, 4 = quite a bit, 5 = extremely or a great deal) where 1 generally represents better responses on items and 5 represents worse responses; | (at baseline and after 8 weeks) | 
| 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) |