Response To Medical Therapy in Inflammatory Bowel Disease Patients Carrying-out a Prescribed Exercise Programme

Royal College of Surgeons, Ireland

Status: Unknown

Conditions: Inflammatory Bowel Diseases

Treatments: Behavioral: Physician-prescribed Exercise Programme; Drug: Best Medical Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05174754

21-048

Details and patient eligibility

About

The investigators propose the use of a 20 week physician-derived exercise programme will lead to an improvement in physical fitness which will in turn lead to an increase in muscle mass, a reduction in visceral obesity resulting in an improvement in biologic response, disease biomarkers (including a reduction in circulating pro-inflammatory cytokines), fatigue scores and quality of life.

Full description

After completion, the investigators expect to describe the significant impact that exercise has on IBD disease control, response to biologics, modification of pro-inflammatory cytokine levels, quality of life and fatigue scores.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 years of age or above.
• Confirmed moderate to severe inflammatory bowel disease based on endoscopic evaluation, clinical scoring tools and faecal calprotectin.
• Be able to provide written informed consent.
• Stable dose of steroids.
• Physically able to complete an exercise programme.
• Healthy controls.

Exclusion criteria

• Inability to participate in the exercise program (unable to perform 6MWT, unable to attend for assessment of parameters at any time point).
• An uncontrolled cardiovascular condition such as unstable angina, uncontrolled cardiac arrhythmias, uncontrolled symptomatic heart failure or symptomatic severe aortic stenosis.
• A significant musculoskeletal condition, neurological condition, mental illness or intellectual disability that restricts participation in a physical exercise program.
• Pregnancy.
• Healthy controls with underlying inflammatory conditions.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 3 patient groups

Inflammatory Bowel Disease Exercise Group

Experimental group

Description:

The exercise group will be randomized to a 20-week physician-prescribed exercise programme following the principles of Frequency, Intensity, Time, and Type (FITT) in addition to best medical therapy with the aim of increasing physical fitness levels, inflammatory response, quality of life/fatigue improvements and favorable body composition changes.

Treatment:

Drug: Best Medical Therapy

Behavioral: Physician-prescribed Exercise Programme

Inflammatory Bowel Disease Control Group

Other group

Description:

The IBD control group will be randomized to best medical therapy alone.

Treatment:

Drug: Best Medical Therapy

Healthy Control Group

No Intervention group

Description:

A group of healthy controls without inflammatory bowel disease will be included in the study for comparison of inflammatory markers including cytokine analysis and body composition.