The IBD-FITT Study - Moderate-intensity Exercise for Patients With Inflammatory Bowel Disease With Moderate Disease Activity: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Inflammatory Bowel Disease Questionnaire (IBDQ)
研究概览
简要总结
The investigators aim to investigate whether exercise therapy during 12 weeks including a lesson on general healthy lifestyle in adult patients with a moderately active disease is more effective, compared to control patients only receiving a lesson on general healthy lifestyle recommendations. The three main categories of outcomes are 1) health-related quality of life, 2) general health status of the patients 3) explorative outcomes. The primary outcome is health-related quality of life, the secondary outcome is general health status measured by waist circumference, disease activity scores, blood pressure, and blood lipids, and the third outcome are explorative outcomes (none-disease specific quality of life scores, biomarkers of C-reactive protein, fecal calprotectin and immunology markers including interleukins).
详细描述
The investigators will apply a superior trial design in this randomized clinical trial with two arms, intervention and comparison. In both the intervention and comparison arm, the patients will receive the proper and usual medical treatment decided by their responsible physician and changes in the medical treatment is allowed at all times.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with moderately active Crohn's disease or ulcerative colitis are defined by fulfilling all the following five criteria:
- •Well-characterized Crohn's disease or ulcerative colitis (physician assessment) i. Fulfilling standard clinical, endoscopic, radiologic, and histological criteria
- •A minimum of one-year disease duration from the time of diagnosis of Crohn's disease or ulcerative colitis to inclusion into the trial
- •Any of the following pharmacological treatments in a period of three months prior to inclusion:
- •i. Usage of 5-Aminosalicylic acid (5-ASA) ii. Usage of corticosteroids iii. Immunomodulators usage: Azathioprine (AZA), 6-mercaptopurine (6-MP), Methotrexate (MTX) iv. Biologics usage: Anti-TNFα (Infliximab, Adalimumab, Golimumab), Ustekinumab or Anti-integrin (Vedolizumab)
- •Disease activity defined by clinical disease score:
- •i. Harvey Bradshaw Index (HBI) 27 > 5 ii. Simple Clinical Colitis Activity Index (SCCAI) 29 > 5
- •Marker for gastrointestinal inflammation:
- •i. Fecal calprotectin (FC) > 200 mg/g
排除标准
- •A language barrier that prohibits the exercise instructors/supervisors to give sufficient or safe instructions during the intervention or at the general health lesson.
- •Known heart condition that prevents them to actively participate safely in the exercise intervention.
- •Known pregnancy or planned pregnancy.
- •Disabling musculoskeletal injuries that prevent them to actively participate in the exercise intervention.
- •Severe disease activity manifested clinically and with the need for urgent change in treatment evaluated by the responsible physician.
研究组 & 干预措施
Exercise
In the intervention arm, a 12-week aerobic exercise program tailored to the individual patients by physiotherapists using the principles of Frequency, Intensity, Time, and, Type (FITT) aiming to increase or maintain the physical activity level to a weekly moderate activity level.
干预措施: Exercise intervention (Behavioral)
Exercise
In the intervention arm, a 12-week aerobic exercise program tailored to the individual patients by physiotherapists using the principles of Frequency, Intensity, Time, and, Type (FITT) aiming to increase or maintain the physical activity level to a weekly moderate activity level.
干预措施: Lifestyle - online lesson intervention (Behavioral)
Comparison
Comparison
干预措施: Lifestyle - online lesson intervention (Behavioral)
结局指标
主要结局
Inflammatory Bowel Disease Questionnaire (IBDQ)
时间窗: 12 weeks
Health-related quality of life
次要结局
- General health - blood pressure(12 weeks)
- General health - Clinical disease activity(12 weeks)
- General health - Lipid(12 weeks)
- General health - Waist circumference(12 weeks)
研究者
Ken Lund
Principal Investigator
University of Southern Denmark