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

NCT05657197 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-03-25

No results posted yet for this study

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

Interventions

BEHAVIORAL

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.

OTHER

Usual care

Usual care, including general advice concerning chronic fatigue.

Sponsors & Collaborators

  • Dutch Digestive Diseases Foundation

    collaborator OTHER

  • Sport Medisch Centrum Papendal

    collaborator UNKNOWN

  • FormUpgrade, Arnhem

    collaborator UNKNOWN

  • Sport Medisch Centrum, Jeroen Bosch Ziekenhuis

    collaborator UNKNOWN

  • Rijnstate Hospital

    lead OTHER

Principal Investigators

  • Dr. M.J.M. Groenen, MD, PhD · Gastroenterology department, Rijnstate Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-10
Primary Completion
2024-12-31
Completion
2025-12-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05657197 on ClinicalTrials.gov