The Effects of Exercise Training on Fitness, Function and Quality of Life in Youth With Inflammatory Bowel Disease: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Changes in IBD-related symptoms: Pediatric Crohn's Disease Activity Index
研究概览
简要总结
Children and adolescents with inflammatory bowel disease (IBD) suffer from many extra-intestinal side effects, including impaired muscle strength, low aerobic fitness, low bone density, and chronic inflammation. While exercise training can help remedy these issues in adults with IBD, no studies have examined the physiological effects of a structured aerobic and resistance exercise training intervention for youth with IBD.
The aim of this pilot study is to to assess the feasibility, safety, and participant satisfaction of a structured 16-week training program for children with IBD. The secondary objectives of this study were to quantify the effects of a 16-week exercise training program on select physiological and behavioural outcomes in children with IBD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In remission (score of >10) according to the pediatric Crohn's disease activity index (PCDAI) or the ulcerative colitis activity index (PUCAI)
- •Confirmed IBD diagnosis
排除标准
- •Children who exercise train 3 times a week of more
结局指标
主要结局
Changes in IBD-related symptoms: Pediatric Crohn's Disease Activity Index
时间窗: Change from baseline at 8 weeks and 1 week post intervention
Tracking changes in IBD-related symptoms based on Pediatric Crohn's Disease Activity Index (scored 0-100, where higher score indicates more severe disease)
Recruitment
时间窗: Change from baseline at 8 weeks and 1 week post intervention
Measure of patient recruitment (number of patients approached, enrolled, refused)
Retention
时间窗: Change from baseline at 8 weeks and 1 week post intervention
Percent of patients that completed the study after enrolment
Changes in IBD-related symptoms: Pediatric Ulcerative Colitis Activity Index
时间窗: Change from baseline at 8 weeks and 1 week post intervention
Tracking changes in IBD-related symptoms based on Pediatric Ulcerative Colitis Activity Index (scored 0-85, where higher score indicates more severe disease)
Qualitative assessment of participant likes and dislikes of the training program and suggestions for improvement
时间窗: Change from baseline at 8 weeks and 1 week post intervention
Assessed by qualitative interview looking at likes and dislikes of the training program as well as suggestions for improvement
Adherence
时间窗: Change from baseline at 8 weeks and 1 week post intervention
Percent of prescribed exercise completed across sessions
Compliance
时间窗: Change from baseline at 8 weeks and 1 week post intervention
Percent of exercise sessions completed
Tracking adverse events
时间窗: During training session
Adverse events are event that occurs during the course of exercise training that cause the participant physical or psychological harm
次要结局
- Body mass composition absolute values(Change from baseline at 8 weeks and 1 week post intervention)
- Physical activity levels(Change from baseline at 8 weeks and 1 week post intervention)
- Inflammatory cytokine levels(Change from baseline at 8 weeks and 1 week post intervention)
- Aerobic fitness: maximum rate of oxygen consumption attainable during physical exertion(Change from baseline at 8 weeks and 1 week post intervention)
- Aerobic fitness: peak workload(Change from baseline at 8 weeks and 1 week post intervention)
- Aerobic fitness: peak heart rate(Change from baseline at 8 weeks and 1 week post intervention)
- Body mass composition as a percent of total body mass(Change from baseline at 8 weeks and 1 week post intervention)
- Muscle strength(Change from baseline at 8 weeks and 1 week post intervention)
- Bone mineral density(Change from baseline at 8 weeks and 1 week post intervention)
研究者
Brian Timmons
Professor
McMaster University