Clinical trial NCT05174754: Response To Medical Therapy in Inflammatory Bowel Disease Patients Carrying-out a Prescribed Exercise Programme
Official title: The Impact Of A Physician-led Exercise Programme On Quality Of Life, Muscle Mass And Clinical Response In Inflammatory Bowel Disease Patients During Induction With Medical Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inflammatory Bowel Diseases
Lead sponsor: Royal College of Surgeons, Ireland
Sponsor class: OTHER
First posted: 2022-01-03
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The recruitment rates in both IBD arms.
timeFrame: 26 weeks
measure: The retention rate in both IBD arms.
timeFrame: 26 weeks
measure: The adherence rate in both IBD arms.
timeFrame: 26 weeks
Secondary outcomes:
measure: Change in muscle mass measured by ultrasound
timeFrame: 26 weeks
measure: Change in muscle mass measured by bioelectrical impedance analysis
timeFrame: 26 weeks
measure: Change in visceral fat measured by bioelectrical impedance analysis
timeFrame: 26 weeks
measure: Clinical remission in response to exercise intervention
timeFrame: 12 and 26 weeks
measure: Change in fatigue score between the IBD groups in response to exercise
timeFrame: 12 and 26 weeks
measure: Change in Quality of Life in response to exercise
timeFrame: 12 and 26 weeks
measure: Change in endoscopic disease activity between IBD groups
timeFrame: 26 weeks
measure: Inflammatory response between IBD groups measured using C-Reactive protein
timeFrame: 12 and 26 weeks
measure: Inflammatory response between IBD groups measured using faecal calprotectin
timeFrame: 12 and 26 weeks
measure: Inflammatory response between IBD groups measured using pro-inflammatory cytokines
timeFrame: 12 and 26 weeks
measure: Change in handgrip strength
timeFrame: 12 and 26 weeks
measure: A change in physical fitness between the IBD patient arms
timeFrame: 26 weeks
Other outcomes:
measure: Measurement of metabolic markers in response to exercise
timeFrame: 12 and 26 weeks
measure: Adverse events
timeFrame: 26 weeks
Locations:
city: Dublin
country: Ireland
facility: Beaumont Hospital
Study officials:
affiliation: Royal College of Surgeons, Ireland and Beaumont Hospital, Dublin, Ireland.
name: Karen Boland, PhD
role: PRINCIPAL_INVESTIGATOR
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