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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
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
Beaumont Hospital
Dublin, Ireland
RECRUITINGThe recruitment rates in both IBD arms.
A calculation of the percentage of people approached who participate in the intervention (recruitment).
Time frame: 26 weeks
The retention rate in both IBD arms.
A calculation of the percentage of people approached who complete the intervention.
Time frame: 26 weeks
The adherence rate in both IBD arms.
A calculation of the percentage of people approached who adhered to the intervention.
Time frame: 26 weeks
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)
Time frame: 26 weeks
Change in muscle mass measured by bioelectrical impedance analysis
Bioelectrical impedance analysis (muscle mass in Kg)
Time frame: 26 weeks
Change in visceral fat measured by bioelectrical impedance analysis
Bioelectrical impedance analysis (visceral fat in Kg)
Time frame: 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
Time frame: 12 and 26 weeks
Change in fatigue score between the IBD groups in response to exercise
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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").
Time frame: 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.
Time frame: 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).
Time frame: 26 weeks
Inflammatory response between IBD groups measured using C-Reactive protein
Change in C-Reactive Protein (mg/L)
Time frame: 12 and 26 weeks
Inflammatory response between IBD groups measured using faecal calprotectin
Change in faecal calprotectin (ug/g)
Time frame: 12 and 26 weeks
Inflammatory response between IBD groups measured using pro-inflammatory cytokines
Change in circulating pro-inflammatory cytokines (pg/mL)
Time frame: 12 and 26 weeks
Change in handgrip strength
Use of Jamar dynamometer to measure handgrip strength in kPa
Time frame: 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
Time frame: 26 weeks