Calisthenics Versus Cycling Exercises on Interleukin-6 and Quality of Life in Benha University Students With Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Interleukin-6 (IL-6)
研究概览
简要总结
this study will be conducted to compare between the effect of calisthenics versus cycling exercises on interleukin-6 and quality of life in Benha University students with irritable bowel syndrome.
详细描述
Irritable bowel syndrome (IBS) is one of the most common chronic gastro-intestinal disorders affecting up to 20 % of the population all over the world and affecting approximately 9-22% of the European adult population and affecting female more than male.Irritable bowel syndrome (IBS) is one of the most common functional bowel disorders, and has substantial implications for the lives of patients, as well as a huge economic impact on society. The high prevalence of Irritable bowel syndrome (IBS) is associated with a marked reduction in health-related quality of life, higher rates of somatisation, increased likelihood of psychological comorbidity, including depression and suicidal ideation, and work impairment, as well as greater medical and prescription medicine costs per year .Students, especially those who are undergraduates, are highly liable to IBS that is linked to increased stresses as exams and because they always rely on fast foods for their diet. Similarly, dietary pattern has significant negative effect on IBS. IBS can affect the academic performance of the studying students.Physical exercises help people with IBS by increasing the motility of the stomach and encouraging regular bowel movements, lowering stress and anxiety by releasing endorphins, and strengthening the gut microbiota to reduce inflammation and improve barrier function. Additionally, using bodyweight activities can help people with IBS improve their overall quality of life by reducing bloating and improving gas evacuation
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
- Single (Outcomes Assessor)
盲法说明
opaque sealed envelope
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •females will be aged from 18 to 25 years old
- •diagnosis by Rome IV diagnostic criteria
- •BMI will be 18.5- 29.5 kg\m2
- •(Moderate-severe) severity of IBS.
排除标准
- •organic gastro -intestinal disorders
- •thyroid dysfunctions
- •concurrent cardio vascular?
- •respiratory, renal, hepatic disorders
- •neurological/musculoskeletal problems,
- •psychiatric disease,
- •hematological disease,
- •previous history of stomach or intestinal excision.
- •BMI will be >30 kg\m2
- •Participating in any other ex progrm
研究组 & 干预措施
Calisthenics exercises
Twenty patients with IBS will be trained by calisthenics exercises, 3 times per week for 2 months with diet advices.
干预措施: Calisthenics exercises (Other)
Calisthenics exercises
Twenty patients with IBS will be trained by calisthenics exercises, 3 times per week for 2 months with diet advices.
干预措施: diet advices (Other)
Cycling Exercises
Twenty patients with IBS will be trained by cycling exercises, 3 times per week for 2 months, with diet advices.
干预措施: Cycling Exercises (Other)
Cycling Exercises
Twenty patients with IBS will be trained by cycling exercises, 3 times per week for 2 months, with diet advices.
干预措施: diet advices (Other)
diet advices
Twenty patients with IBS will diet advices for 2 months
干预措施: diet advices (Other)
结局指标
主要结局
Interleukin-6 (IL-6)
时间窗: up to eight weeks
Interleukin-6 (IL-6) is measured using methods such as ELISA kits . ELISA kits are widely used, providing reliable, sensitive, and specific measurements.The normal range for Interleukin-6 (IL-6) in healthy adults is typically less than 5 to 7 picograms per milliliter (pg/mL).
Irritable Bowel Syndrome Severity
时间窗: up to eight weeks
Irritable Bowel Syndrome Severity Scoring System will be used to assess bowel severity through five clinically significant items over ten days, as follows: frequency ,severity of abdominal pain , degree of abdominal distention or tightness, dissatisfaction with bowel habits, affection of IBS on quality of life. A greater score denotes worse conditions. Each item is rated on a visual analog scale (VAS) from 0 to 100, resulting in an overall score ranging from 0 to 500. Based on the data collected, the IBS-SSS scores are divided into three categories: mild symptoms (from 75 to 174), moderate symptoms (from 175 to 299), and severe symptoms (from 300 to 500) Additionally, a 95-point reduction in total IBS-SSS scores is clinically meaningful, indicating an improvement in symptoms.
Frequency of complete spontaneous bowel movements
时间窗: up to eight weeks
Defined as a sense of complete evacuation without laxatives, enemas, or suppositories on the day of the bowel movement or the preceding day. A participant with a weekly complete spontaneous bowel movement frequency rate of three or more and an increase of one or more from baseline is considered a responder. The patients reported the number of their complete spontaneous bowel movements per week at baseline and post-intervention
life disability
时间窗: up to eight weeks
Irritable Bowel Syndrome Quality of Life (IBS-QOL) Instrument will be used to assess life disability.A 34-item, patient-reported questionnaire used to assess the health-related quality of life (HRQOL) and the impact of IBS and its treatments on patients' lives. The questionnaire covers eight domains: dysphoria, interference with activity, body image, health worry, food avoidance, social reactions, sexual concerns, and relationships. Responses are given on a 5-point Likert scale, with scores summed and transformed to a 0-100 scale, where higher scores indicate a better quality of life.
次要结局
- aerobic capacity(up to eight weeks)
- Academic achievement(up to eight weeks)
- sleep disability(up to eight weeks)
研究者
Heba Gamal Ali Ali
principle investigator : heba gamal ali ali
Cairo University