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

Recruiting

Conditions: Inflammatory bowel disease (IBD) AND Crohn's disease / ulcerative colitis
10017969

Registration Number: NL-OMON51459

Lead Sponsor: Rijnstate Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

- >= 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
(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);
- Patient is aged between 18 and 67 years

Exclusion Criteria

- Intensive sport activities more than once a week / >90 minutes in the past
year.
- 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Change in fatigue and quality of life after 12-weeks physical exercise in the<br /><br>intervention group compared to the control group. (short term, after 3 months)<br /><br>Fatigue complaints will be measured with the inflammatory bowel disease fatigue<br /><br>self-assessment scale (IBD-F) and quality of life will be measured with the<br /><br>IBD-questionnaire (IBDQ). </p><br>

Secondary Outcome Measures