The Effect of Intensive Physical Exercise on Fatigue and Quality of Life in Patients With Quiescent Inflammatory Bowel Disease

NCT05657197 | Recruiting

• 1 other identifier: NL81794.091.22
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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.

Conditions

Inflammatory Bowel Diseases

Keywords

Fatigue; Exercise; Quality of life; IBD

Outcome Measures

Primary Outcomes (2)

• Change in fatigue (IBD-F), 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.

  3 months (post-intervention)

• Change in quality of life (IBDQ), 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.

  3 months (post-intervention)

Secondary Outcomes (17)

• 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)

Study Arms (2)

Intervention (exercise) group

EXPERIMENTAL

The patients in the intervention group will follow a personalised and intensive exercise program.

Behavioral: Exercise intervention

Control group

OTHER

The patients in the control group will receive usual care.

Other: Usual care

Interventions

Exercise intervention BEHAVIORAL

A 12-week exercise program consisting of three times per week 1-hour sessions, including 30-minutes aerobic- and 30-minutes progressive resistance training. The intensity of training will be adjusted to each individual, based on a cardiopulmonary exercise test. Training sessions will be performed in groups of 10 participants under supervision of a sports physical therapist.

Intervention (exercise) group

Usual care OTHER

Usual care, including general advice concerning chronic fatigue.

Control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ≥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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rijnstate Hospital: lead
• Dutch Digestive Diseases Foundation: collaborator
• Sport Medisch Centrum Papendal: collaborator
• FormUpgrade, Arnhem: collaborator
• Sport Medisch Centrum, Jeroen Bosch Ziekenhuis: collaborator

Study Sites (3)

Rijnstate Hospital

Arnhem, Gelderland, 6815 AD, Netherlands

RECRUITING

Radboud Univeristy Medical Center

Nijmegen, Gelderland, 6525 GA, Netherlands

RECRUITING

Jeroen Bosch Hospital

's-Hertogenbosch, S' Hertogenbosch, 5223 GZ, Netherlands

RECRUITING

Related Publications (1)

• 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.

  PMID: 32239380 BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Fatigue; Motor Activity

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Dr. M.J.M. Groenen, MD, PhD

  Gastroenterology department, Rijnstate Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

D Oomkens, MD MSc

CONTACT

088 - 005 6800; Energize_IBD@rijnstate.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Multicentre parallel randomised controlled trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: December 20, 2022
• Study Start: January 10, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: March 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (3)