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The IBD-FITT Study - Moderate-intensity Exercise for IBD Patients With Moderate Disease Activity

NCT04816812 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2023-12-04

No results posted yet for this study

Summary

The investigators aim to investigate whether exercise therapy during 12 weeks including a lesson on general healthy lifestyle in adult patients with a moderately active disease is more effective, compared to control patients only receiving a lesson on general healthy lifestyle recommendations. The three main categories of outcomes are 1) health-related quality of life, 2) general health status of the patients 3) explorative outcomes. The primary outcome is health-related quality of life, the secondary outcome is general health status measured by waist circumference, disease activity scores, blood pressure, and blood lipids, and the third outcome are explorative outcomes (none-disease specific quality of life scores, biomarkers of C-reactive protein, fecal calprotectin and immunology markers including interleukins).

Conditions

  • Inflammatory Bowel Diseases

Interventions

BEHAVIORAL

Exercise intervention

A 12-week aerobic exercise program tailored to the individual patients by physiotherapists using the principles of Frequency, Intensity, Time, and, Type (FITT) aiming to increase or maintain the physical activity level to a weekly moderate activity level. This includes two supervised exercise sessions of 60 minutes per week, combined with one weekly home training session. The type of exercise is planned by a physiotherapist to fit each patient during sessions. We monitor the intervention by training diaries including frequency, intensity, time, and type of exercise (FITT) and the verbal BORG 15-point scale and heart rate monitors. We will also monitor the overall seven days' physical activity level by accelerometry using the AX3 device from the company Axivity at weeks 0 and 12.

BEHAVIORAL

Lifestyle - online lesson intervention

The investigators offer one online lesson of 15-25 minutes on lifestyle guidance including general advice on healthy living.

Sponsors & Collaborators

  • University of Southern Denmark

    lead OTHER

Principal Investigators

  • Ken Lund, PhD · Odense University Hospital & University of Southern Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-11-15
Primary Completion
2023-05-31
Completion
2023-05-31

Countries

  • Denmark

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 NCT04816812 on ClinicalTrials.gov