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The Effect of Intensive Physical Exercise on Fatigue and Quality of Life in Patients With Quiescent Inflammatory Bowel Disease | Clinical Trials | Clareo Health

RECRUITINGNA

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

NCT05657197•Rijnstate Hospital

View on ClinicalTrials.gov

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

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

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))
+11 more criteria

Locations (3)

Rijnstate Hospital

Arnhem, Gelderland, Netherlands

Radboud Univeristy Medical Center

Nijmegen, Gelderland, Netherlands

Jeroen Bosch Hospital

's-Hertogenbosch, S' Hertogenbosch, Netherlands

Key Dates

Start Date

January 10, 2023

Primary Completion Date

December 1, 2024

Completion Date

December 1, 2025

Last Updated

March 25, 2024

Enrollment

100

ESTIMATED participants

Conditions

Inflammatory Bowel Diseases

Interventions

Exercise intervention

BEHAVIORAL

Usual care

OTHER

Contacts

D Oomkens, MD MSc

CONTACT

088 - 005 6800 Energize_IBD@rijnstate.nl

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 25, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

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Exclusion Criteria

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