Clinical trial NCT05657197: The Effect of Intensive Physical Exercise on Fatigue and Quality of Life in Patients With Quiescent Inflammatory Bowel Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Inflammatory Bowel Diseases
Keywords: Fatigue
Exercise
Quality of life
IBD
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
Collaborators: name: Dutch Digestive Diseases Foundation
name: Sport Medisch Centrum Papendal
name: FormUpgrade, Arnhem
name: Sport Medisch Centrum, Jeroen Bosch Ziekenhuis
First posted: 2022-12-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: Change in fatigue (IBD-F), post-intervention
timeFrame: 3 months (post-intervention)
measure: Change in quality of life (IBDQ), post-intervention
timeFrame: 3 months (post-intervention)
Secondary outcomes:
measure: Long-term change in fatigue (IBD-F)
timeFrame: 6- and 12-months
measure: Long-term change in quality of life (IBDQ)
timeFrame: 6- and 12-months
measure: Change in cardiorespiratory fitness (maximum oxygen uptake)
timeFrame: 3 months (post-intervention)
measure: Change in cardiorespiratory fitness (maximum power)
timeFrame: 3 months (post-intervention)
measure: Change in muscular strength
timeFrame: 3 months (post-intervention)
measure: Change in body composition (BMI)
timeFrame: 3 months (post-intervention)
measure: Change in body composition (body fat percentage)
timeFrame: 3 months (post-intervention)
measure: Change in work absenteeism and presenteeism
timeFrame: T= 3-, 6-, 9-, and 12-months
measure: Disease activity (FCP)
timeFrame: T= 3-, 6-, 9-, and 12-months
measure: Disease activity (step-up therapy)
timeFrame: T= 3-, 6-, 9-, and 12-months
measure: Disease activity (exacerbation rate)
timeFrame: T= 3-, 6-, 9-, and 12-months
measure: Change in sleep quality
timeFrame: T= 3-, 6-, 9-, and 12-months
measure: Change in anxiety and depression symptoms
timeFrame: T= 3-, 6-, 9-, and 12-months
measure: Targeted cost-utility analysis
timeFrame: 12 months
measure: Exploratory outcome measurements (immunological profiles)
timeFrame: 3 months (post-intervention)
measure: Exploratory outcome measurements (gut microbiota)
timeFrame: 3 months (post-intervention)
measure: Exploratory outcome measurements (biogenic amines)
timeFrame: 3 months (post-intervention)
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
state: Gelderland
city: Nijmegen
country: Netherlands
facility: Radboud Univeristy Medical Center
state: Gelderland
city: Den Bosch
country: Netherlands
facility: Jeroen Bosch Hospital
state: S' Hertogenbosch
Study officials:
affiliation: Gastroenterology department, Rijnstate Hospital
name: Dr. M.J.M. Groenen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Erp LW, Roosenboom B, Komdeur P, Dijkstra-Heida W, Wisse J, Horjus Talabur Horje CS, Liem CS, van Cingel REH, Wahab PJ, Groenen MJM. Improvement of Fatigue and Quality of Life in Patients with Quiescent Inflammatory Bowel Disease Following a Personalized Exercise Program. Dig Dis Sci. 2021 Feb;66(2):597-604. doi: 10.1007/s10620-020-06222-5. Epub 2020 Apr 1.