Response To Medical Therapy in Inflammatory Bowel Disease Patients Carrying-out a Prescribed Exercise Programme
- Conditions
- Inflammatory Bowel Diseases
- Interventions
- Behavioral: Physician-prescribed Exercise ProgrammeDrug: Best Medical Therapy
- Registration Number
- NCT05174754
- Lead Sponsor
- Royal College of Surgeons, Ireland
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 70
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Inflammatory Bowel Disease Exercise Group Best Medical Therapy 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. Inflammatory Bowel Disease Exercise Group Physician-prescribed Exercise Programme 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. Inflammatory Bowel Disease Control Group Best Medical Therapy The IBD control group will be randomized to best medical therapy alone.
- Primary Outcome Measures
Name Time Method The recruitment rates in both IBD arms. 26 weeks A calculation of the percentage of people approached who participate in the intervention (recruitment).
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.
- Secondary Outcome Measures
Name Time Method Change in muscle mass measured by bioelectrical impedance analysis 26 weeks Bioelectrical impedance analysis (muscle mass in Kg)
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)
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").
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 pro-inflammatory cytokines 12 and 26 weeks Change in circulating pro-inflammatory cytokines (pg/mL)
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 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.
Change in handgrip strength 12 and 26 weeks Use of Jamar dynamometer to measure handgrip strength in kPa
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).
Inflammatory response between IBD groups measured using faecal calprotectin 12 and 26 weeks Change in faecal calprotectin (ug/g)
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
Trial Locations
- Locations (1)
Beaumont Hospital
🇮🇪Dublin, Ireland