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

NCT ID: NCT05657197

Last Updated: 2024-03-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-10
• Study Completion Date: 2025-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention (exercise) group

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

Group Type: EXPERIMENTAL

Exercise intervention

Intervention Type: 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.

Control group

The patients in the control group will receive usual care.

Group Type: OTHER

Usual care

Intervention Type: OTHER

Usual care, including general advice concerning chronic fatigue.

Interventions

Exercise intervention

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 Type: BEHAVIORAL

Usual care

Usual care, including general advice concerning chronic fatigue.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dutch Digestive Diseases Foundation

OTHER

Sponsor Role: collaborator

Sport Medisch Centrum Papendal

UNKNOWN

Sponsor Role: collaborator

FormUpgrade, Arnhem

UNKNOWN

Sponsor Role: collaborator

Sport Medisch Centrum, Jeroen Bosch Ziekenhuis

UNKNOWN

Sponsor Role: collaborator

Rijnstate Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr. M.J.M. Groenen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Gastroenterology department, Rijnstate Hospital

Locations

Rijnstate Hospital

Arnhem, Gelderland, Netherlands

Site Status: RECRUITING

Radboud Univeristy Medical Center

Nijmegen, Gelderland, Netherlands

Site Status: RECRUITING

Jeroen Bosch Hospital

's-Hertogenbosch, S' Hertogenbosch, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

D Oomkens, MD MSc

Role: CONTACT

Energize_IBD@rijnstate.nl

088 - 005 6800

Facility Contacts

D Oomkens, MD MSc

Role: primary

Energize_IBD@rijnstate.nl

088 - 005 6800

D Oomkens, MD MSc

Role: primary

Energize_IBD@rijnstate.nl

06 - 50 08 45 90

D Oomkens, MD MSc

Role: primary

Energize_IBD@rijnstate.nl

06 - 50 08 45 90

References

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.

Reference Type: BACKGROUND

PMID: 32239380 (View on PubMed)

Other Identifiers

NL81794.091.22

Identifier Type: -

Identifier Source: org_study_id