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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Inflammatory Bowel Diseases

Intervention / Treatment
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* Behavioral: Physician-prescribed Exercise Programme
* Drug: Best Medical Therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inflammatory Bowel Disease Exercise Group<br>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. | Behavioral: Physician-prescribed Exercise Programme<br>* A 20-week structured exercise programme derived and supervised by a Sports Medicine Physician following the FITT Principles<br>Drug: Best Medical Therapy<br>* Best medical therapy with biologic agent or small-molecule therapy<br>|
| Other: Inflammatory Bowel Disease Control Group<br>The IBD control group will be randomized to best medical therapy alone. | Drug: Best Medical Therapy<br>* Best medical therapy with biologic agent or small-molecule therapy<br>|
| No Intervention: Healthy Control Group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The recruitment rates in both IBD arms. | A calculation of the percentage of people approached who participate in the intervention (recruitment). | 26 weeks | 
| The retention rate in both IBD arms. | A calculation of the percentage of people approached who complete the intervention. | 26 weeks | 
| The adherence rate in both IBD arms. | A calculation of the percentage of people approached who adhered to the intervention. | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in muscle mass measured by ultrasound | Ultrasound of thigh muscle mass (vastus intermedius and rectus femoris-measured in mm, subcutaneous adiposity measured in mm) | 26 weeks | 
| Change in muscle mass measured by bioelectrical impedance analysis | Bioelectrical impedance analysis (muscle mass in Kg) | 26 weeks | 
| Change in visceral fat measured by bioelectrical impedance analysis | Bioelectrical impedance analysis (visceral fat in Kg) | 26 weeks | 
| Clinical remission in response to exercise intervention | Harvey Bradshaw Index 2 or lower in Crohn's disease patients or partial Mayo score 0-1in ulcerative colitis | 12 and 26 weeks | 
| Change in fatigue score between the IBD groups in response to exercise | Measured using the Fatigue Severity Scale which comprises nine statements, describing the severity and impact of fatigue, with a scale of possible responses ranging from 1 (strongly disagree) to 7 (strongly agree). | 12 and 26 weeks | 
| Change in Quality of Life in response to exercise | Measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)- a ten item questionnaire, with 1 to 7 points for each item and higher scores indicating higher quality of life. | 12 and 26 weeks | 
| Change in endoscopic disease activity between IBD groups | A change in endoscopic appearance of Crohn's using Simple endoscopic score for Crohn's disease (SES CD) (inactive when SES-CD was 0-2; mild when 3-6; moderate 7-15; and severe >16) or Mayo score for ulcerative colitis (Score 0-3, Mayo 3 indicating severe disease, 2 moderate disease, 1 mild disease and 0 inactive). | 26 weeks | 
| Inflammatory response between IBD groups measured using C-Reactive protein | Change in C-Reactive Protein (mg/L) | 12 and 26 weeks | 
| Inflammatory response between IBD groups measured using faecal calprotectin | Change in faecal calprotectin (ug/g) | 12 and 26 weeks | 
| Inflammatory response between IBD groups measured using pro-inflammatory cytokines | Change in circulating pro-inflammatory cytokines (pg/mL) | 12 and 26 weeks | 
| Change in handgrip strength | Use of Jamar dynamometer to measure handgrip strength in kPa | 12 and 26 weeks | 
| A change in physical fitness between the IBD patient arms | 15% difference in 6-minute walk test (6MWT) distance between the two groups | 26 weeks |