Intensive exercise to improve fatigue and quality of life in patients with inflammatory bowel disease

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

This study is testing whether a personalized intensive exercise program can help people with inflammatory bowel disease feel less tired and improve their quality of life.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Rijnstate Hospital (other)
• Locations: 3 sites (Arnhem, Gelderland and 2 other locations)
• Trial ID: NCT05657197 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of an intensive physical exercise program on fatigue and quality of life in patients with quiescent inflammatory bowel disease (IBD). The study aims to address the prevalent issue of chronic fatigue in IBD patients, which is often linked to impaired physical fitness. Participants will engage in a personalized exercise regimen over 12 weeks, with the goal of assessing improvements in fatigue levels and overall well-being. The trial is a multicenter randomized controlled design, building on previous pilot findings that indicated positive outcomes from exercise interventions.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with IBD for at least one year who experience chronic fatigue and have clinically quiescent disease.

Not a fit: Patients with active inflammatory bowel disease or those who do not experience chronic fatigue may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new complementary treatment approach to alleviate fatigue and enhance the quality of life for patients with IBD.

How similar studies have performed: Previous pilot studies have shown significant improvements in fatigue and quality of life with similar exercise interventions, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

* ≥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.

Exclusion Criteria:

* 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
  * BMI ≥35

Where this trial is running

Arnhem, Gelderland and 2 other locations

• Rijnstate Hospital — Arnhem, Gelderland, Netherlands (RECRUITING)
• Radboud Univeristy Medical Center — Nijmegen, Gelderland, Netherlands (RECRUITING)
• Jeroen Bosch Hospital — Den Bosch, S' Hertogenbosch, Netherlands (RECRUITING)

Study contacts

• Principal investigator: Dr. M.J.M. Groenen, MD, PhD — Gastroenterology department, Rijnstate Hospital
• Study coordinator: D Oomkens, MD MSc

Conditions: Inflammatory Bowel Diseases, Fatigue, Exercise, Quality of life, IBD