Inflammatory Bowel Diseases
Conditions
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.
Interventions
BEHAVIORALPhysician-prescribed Exercise Programme
A 20-week structured exercise programme derived and supervised by a Sports Medicine Physician following the FITT Principles
Best medical therapy with biologic agent or small-molecule therapy
Sponsors
Royal College of Surgeons, Ireland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The retention rate in both IBD arms. | 26 weeks | A calculation of the percentage of people approached who complete the intervention. |
| The adherence rate in both IBD arms. | 26 weeks | A calculation of the percentage of people approached who adhered to the intervention. |
| The recruitment rates in both IBD arms. | 26 weeks | A calculation of the percentage of people approached who participate in the intervention (recruitment). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in muscle mass measured by bioelectrical impedance analysis | 26 weeks | Bioelectrical impedance analysis (muscle mass in Kg) |
| Change in visceral fat measured by bioelectrical impedance analysis | 26 weeks | Bioelectrical impedance analysis (visceral fat in Kg) |
| Change in fatigue score between the IBD groups in response to exercise | 12 and 26 weeks | 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). |
| Change in Quality of Life in response to exercise | 12 and 26 weeks | 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. |
| Inflammatory response between IBD groups measured using C-Reactive protein | 12 and 26 weeks | Change in C-Reactive Protein (mg/L) |
| Inflammatory response between IBD groups measured using faecal calprotectin | 12 and 26 weeks | Change in faecal calprotectin (ug/g) |
| Inflammatory response between IBD groups measured using pro-inflammatory cytokines | 12 and 26 weeks | Change in circulating pro-inflammatory cytokines (pg/mL) |
| Change in handgrip strength | 12 and 26 weeks | Use of Jamar dynamometer to measure handgrip strength in kPa |
| A change in physical fitness between the IBD patient arms | 26 weeks | 15% difference in 6-minute walk test (6MWT) distance between the two groups |
| Change in endoscopic disease activity between IBD groups | 26 weeks | 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). |
| Clinical remission in response to exercise intervention | 12 and 26 weeks | Harvey Bradshaw Index 2 or lower in Crohn's disease patients or partial Mayo score 0-1in ulcerative colitis |
| Change in muscle mass measured by ultrasound | 26 weeks | Ultrasound of thigh muscle mass (vastus intermedius and rectus femoris-measured in mm, subcutaneous adiposity measured in mm) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Measurement of metabolic markers in response to exercise | 12 and 26 weeks | Analysis of key immunometabolic pathways including flow cytometry of peripheral T-cells |
| Adverse events | 26 weeks | The frequency and nature of adverse events will be recorded (number, percentage and type). |
Countries
Ireland
Contacts
Primary ContactKaren Boland, PhD
Backup ContactNeasa Mc Gettigan, MB BCh, MSc
Outcome results
None listed