A Trial to Determine the Effects of Exercise in Inflammatory Bowel Disease and Rheumatoid Arthritis (ExMET-IBD)
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|ClinicalTrials.gov Identifier: NCT02463916|
Recruitment Status : Unknown
Verified June 2015 by Professor Fergus Shanahan, University College Cork.
Recruitment status was: Recruiting
First Posted : June 4, 2015
Last Update Posted : June 4, 2015
|Condition or disease||Intervention/treatment||Phase|
|Inflammatory Bowel Disease Rheumatoid Arthritis||Other: Exercise||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||The ExMET-IBD Study: A Randomized Control Trial to Determine the Effects of Exercise on Intestinal Microbiota and Immunological Markers in Patients With Inflammatory Bowel Disease and Rheumatoid Arthritis|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||June 2016|
Active Comparator: Immediate exercise
This group will immediately commence an 8 week exercise programme.
8 week structured exercise programme
Active Comparator: Delayed exercise
This group will continue regular activities for 8 weeks and then commence 8 week exercise programme.
8 week structured exercise programme
- Body composition alterations in patients with exercise. [ Time Frame: 8 weeks ]To determine the metabolic and body composition alterations that occur in these patients with exercise as measured by changes in body fat composition measured using DEXA imaging and relate these changes to microbiota change
- Changes in fecal bile acids [ Time Frame: 8 weeks ]Patinets fecal bile acids will be measured pre and post intervention
- Changes in markers of intestinal inflammation (faecal calprotectin) that occur with exercise [ Time Frame: 8 weeks ]Changes in markers of intestinal inflammation (faecal calprotectin) that occur with exercise will be measured
- Alterations in gut microbiota [ Time Frame: 8 weeks ]To compare alterations in gut microbiota following similar levels of exercise to previously recruited and exercised controls (The ExMET study)
- Impact of medium-term moderate intensity exercise on resting inflammatory profiles (cytokines) in these patients. [ Time Frame: 8 weeks ]
- Changes in Harvey Bradshaw index in subjects with Crohn's disease [ Time Frame: 8 weeks ]In subjects with Crohn's disease we will determine if exercise leads to changes in disease activity as determined by the Harvey Bradshaw disease activity score.
- Changes in Powell tuck score in subjects with ulcerative colitis [ Time Frame: 8 weeks ]In subjects with ulcerative colitis we will determine if exercise leads to changes in disease activity score as determined by the Powell tuck score
- Changes in DAS-28 CRP score in subjects with rheumatoid arthritis [ Time Frame: 8 weeks ]In subjects with rheumatoid arthritis we will determine if exercise leads to changes in disease activity scores as determined by the DAS-28 CRP score.
- Changes in Predicted VO2 max via 1-mile walk test (Rockport test) [ Time Frame: 8 weeks ]Changes in physical fitness as determined using predicted VO2 max via 1-mile walk test (Rockport test) resulting from the intervion will be measured.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02463916
|Contact: Owen Cronin, MB BAO BCHfirstname.lastname@example.org|
|Contact: Donal Sheehan, MB BAO BCHemail@example.com|
|Alimentary Pharmabiotic Centre, University College Cork||Recruiting|
|Contact: Susan Rafferty - McArdle, PhD firstname.lastname@example.org|
|Principal Investigator:||Fergus Shanahan, MD, DSc.||Professor and Chair Dept. of Medicine, University College Cork|