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 - ENERGIZE-IBD

Rijnstate Ziekenhuis0 个研究点目标入组 100 人开始时间: 待定最近更新: 2024年7月15日

适应症

试验速览

暂无简介。

•- >= 1 year diagnosis of IBD (including Crohn*s disease, ulcerative colitis and
•IBD-unclassified) based on a combination of clinical, endoscopic, histologic
•and radiologic internationally accepted criteria;
•- Severe fatigue complaints >3 months as confirmed with a score of >=11 on
•section I of the inflammatory bowel disease fatigue self-assessment scale
•- 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);
•- Patient is aged between 18 and 67 years

•- Intensive sport activities more than once a week / >90 minutes in the past
•- Past surgery within 6 months before or planned surgery 12 months after the
•screening visit
•- Comorbidities that could be confounders for fatigue; (such as severe
•cardiorespitory disease, active malignancy, post-COVID or treatment for a
•psychiatric disorder)
•-Comorbidities that prevent safe participation in the exercise
•program/cardiorespiratory fitness test (including cardiorespitory diseases,
•BMI>=35, physical disabillities that compromise exercise performances).
•- Pregnant at the moment of the screening visit or planning pregnancy within 12
•months after the screening.
•- Participation in another medical research.

发起方

Rijnstate Ziekenhuis