ENERGIZE IBD - The Effect of Intensive Physical Exercise on Fatigue and Quality of Life in Patients With Quiescent Inflammatory Bowel Disease: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- Change in quality of life (IBDQ), post-intervention
研究概览
简要总结
In patients with inflammatory bowel diseases (IBD), characterized by relapsing intestinal inflammation, chronic fatigue is a burdensome and highly prevalent symptom. The aetiology is thought to be multifactorial, including complex interactions of psychological and physical factors such as immunological profiles and gut microbiota. Unfortunately, specific treatment strategies are currently lacking. Since fatigued patients have an impaired physical fitness and are less physically active than patients without fatigue, it is hypothesised that physical exercise might be an effective complementary treatment for patients with IBD suffering from fatigue. During a previous pilot cohort study, significant improvements in fatigue complaints and quality of life were observed following a personalised and intensive exercise program. In this study, a multicenter randomized controlled trial will be performed to further investigate this assumed beneficial effect of intensive physical exercise.
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
盲法说明
Multicentre parallel randomised controlled trial
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥1 year diagnosis of IBD, including Crohn's disease (CD), ulcerative colitis (UC) and IBD-unclassified (IBD-U), based on a combination of clinical, endoscopic, histologic and radiologic internationally accepted criteria;
- •Chronic fatigue complaints for at least 3 months;
- •Severe fatigue complaints as confirmed with a score of ≥11 on section I of the inflammatory bowel disease fatigue self-assessment scale (IBD-F);
- •Clinically quiescent IBD with a Harvey Bradshaw Index (HBI) <5 for Crohn's disease patients or a Simple Colitis Clinical Activity Index (SCCAI) ≤2 for patients with ulcerative colitis or IBD-unclassified;
- •Faecal calprotectin <100 μg/g;
- •Stable medication for at least 3 months before screening visit;
- •Patient is able and willing to provide written informed consent;
- •Patient is able/commitment to make a time investment to complete the intervention program (one hour training 3x/week during 12 weeks) or, after randomisation, willing to participate in the control group;
- •Patient is aged between 18 and 60 years.
排除标准
- •Performing moderate-vigorous intensity exercise (i.e. swimming, running, cycling) more than once and/or >90 minutes per week in the past 3 months;
- •Surgery within the past 6 months or planned surgery within 12 months after the screening visit;
- •Participation in another intervention study;
- •Pregnant at the moment of the screening visit or planning pregnancy within 12 months after the screening;
- •Confirmed diagnosis of other causes of fatigue complaints, such as thyroid dysfunction, liver or renal failure, anaemia, folate-, iron-, vitamin B12- or D deficiency.
- •Comorbidities that could be confounders for fatigue, such as Chronic obstructive pulmonary disease (COPD), heart failure, active malignancy, long/Post-COVID and patients under treatment for a psychiatric disorder (i.e. depression/anxiety)
- •Comorbidities that prevent safe participation in the exercise program/cardiorespiratory fitness test including;
- •Very high risk of cardiovascular disease
- •Uncontrolled diabetes mellitus with HbA1c > 65 mmol/l.
- •Cardiovascular disease (i.e. acute myocardial infarct, unstable angina, uncontrolled arrhythmias, aortic stenosis, stenotic valvular heart disease, untreated arterial hypertension (>200 mmHg systolic, >120 mmHg diastolic))
- •Acute non-cardiopulmonary disorder that may affect exercise performance or be aggravated by exercise (i.e. infection, thyrotoxicosis)
- •Uncontrolled asthma
- •Pulmonary oedema
- •Significant pulmonary hypertension
- •Acute pulmonary embolus or pulmonary infarction
- •Room air desaturation at rest <85% (exercise with supplemental O2)
- •Respiratory failure
- •Electrolyte abnormalities (sodium, potassium, calcium, magnesium)
- •Mental impairment leading to inability to cooperate
- •Orthopaedic impairment that compromise exercise performance
研究组 & 干预措施
Control group
The patients in the control group will receive usual care.
干预措施: Usual care (Other)
Intervention (exercise) group
The patients in the intervention group will follow a personalised and intensive exercise program.
干预措施: Exercise intervention (Behavioral)
结局指标
主要结局
Change in quality of life (IBDQ), post-intervention
时间窗: 3 months (post-intervention)
Mean change in quality of life, measured with the inflammatory bowel disease questionnaire (IBDQ) 32-224 with higher scores representing better quality of life, in the intervention group compared to the control group.
Change in fatigue (IBD-F), post-intervention
时间窗: 3 months (post-intervention)
Mean change in fatigue, measured with the inflammatory bowel disease fatigue self-assessment scale (IBD-F) 0-140 with higher scores indicating worse fatigue, in the intervention group compared to the control group.
次要结局
- Change in body composition (BMI)(3 months (post-intervention))
- Disease activity (exacerbation rate)(T= 3-, 6-, 9-, and 12-months)
- Long-term change in fatigue (IBD-F)(6- and 12-months)
- Long-term change in quality of life (IBDQ)(6- and 12-months)
- Change in cardiorespiratory fitness (maximum oxygen uptake)(3 months (post-intervention))
- Change in cardiorespiratory fitness (maximum power)(3 months (post-intervention))
- Change in muscular strength(3 months (post-intervention))
- Disease activity (step-up therapy)(T= 3-, 6-, 9-, and 12-months)
- Targeted cost-utility analysis(12 months)
- Change in body composition (body fat percentage)(3 months (post-intervention))
- Disease activity (FCP)(T= 3-, 6-, 9-, and 12-months)
- Change in anxiety and depression symptoms(T= 3-, 6-, 9-, and 12-months)
- Exploratory outcome measurements (biogenic amines)(3 months (post-intervention))
- Change in work absenteeism and presenteeism(T= 3-, 6-, 9-, and 12-months)
- Exploratory outcome measurements (immunological profiles)(3 months (post-intervention))
- Change in sleep quality(T= 3-, 6-, 9-, and 12-months)
- Exploratory outcome measurements (gut microbiota)(3 months (post-intervention))