Effect of Pilates Exercises on Symptom Severity in Patients With Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Irritable bowel syndrome symptom severity
研究概览
简要总结
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.
详细描述
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:
- -Irritable bowel syndrome symptom severity score (IBS-SSS) will be used to measure severity of IBS symptoms
- number of bowel movements per week will be recorded
- The hospital anxiety and depression scale will be used to assess depression and anxiety
- Modified Fatigue Impact scale (MFIS): was developed to assess the perceived impact of fatigue on a variety of daily activities.
- 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). .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 -
结局指标
主要结局
Irritable bowel syndrome symptom severity
时间窗: (at baseline and after 8 weeks)
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
次要结局
- number of Bowel movement((at baseline and after 8 weeks))
- body weight((at baseline and after 8 weeks))
- Fatigue((at baseline and after 8 weeks))
- Anxiety and depression((at baseline and after 8 weeks))
研究者
Doaa Mohammed Mahmoud Allam
assistant lecturer
Cairo University