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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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29 June 2015 |
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Main ID: |
NCT02463916 |
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Date of registration:
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10/03/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Trial to Determine the Effects of Exercise in Inflammatory Bowel Disease and Rheumatoid Arthritis
ExMET-IBD |
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Scientific title:
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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 |
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Date of first enrolment:
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March 2015 |
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Target sample size:
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60 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02463916 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Ireland
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Contacts
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Name:
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Owen Cronin, MB BAO BCH |
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Address:
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Telephone:
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Email:
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owen.cronin@hotmail.com |
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Affiliation:
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Name:
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Susan Rafferty - McArdle, PhD |
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Address:
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Telephone:
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Email:
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s.rafferty@ucc.ie |
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Affiliation:
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Name:
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Fergus Shanahan, MD, DSc. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Professor and Chair Dept. of Medicine, University College Cork |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 18 - 40 year-old male and females
- BMI between 22 and 35
- Confirmed diagnosis of Crohn's Disease, Ulcerative Colitis or Rheumatoid Arthritis
- Currently inactive i.e. No involvement in regular organized physical activity and
with low weekly physical activity levels - as defined by the International Physical
Activity Questionnaire (IPAQ)
- No regular organized physical activity in the last month
- Subject is willing to comply thoroughly with the basic, standard requirements of the
training program
- Subject is willing to refrain from taking any unspecified dietary, probiotics,
multivitamin or herbal supplements (14-day washout period pre-commencement of
exercise program)
- Participant is happy to confine their formal exercise to within the Mardyke Arena
- Deemed to be fit to participate in exercise program for 8 weeks by the study
investigators
Exclusion Criteria:
- History of coronary artery disease, congenital heart disease or any cardiovascular
disease, including a family history of coronary artery disease before 45 years of
age
- Uncontrolled hypertension (>140/90mmHg) (not white coat)
- Course of antibiotics or bowel preparation for endoscopy one month prior to the
commencement of the exercise program
- Psychiatric disorders
- Any medical condition deemed exclusionary by the Principle Investigator
- A history of substance abuse
- History of total colectomy
- Currently treated with high dose corticosteroids or disease flare within 2 weeks of
starting exercise program
- Pregnant
- History of faecal incontinence
- Have a malignant disease or any concomitant end stage organ disease
- Patients may not be receiving any experimental drug or have been involved in a
recent experimental trial in the last 30 days
Age minimum:
18 Years
Age maximum:
40 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Inflammatory Bowel Disease
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Intervention(s)
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Other: Exercise
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Primary Outcome(s)
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Body composition alterations in patients with exercise.
[Time Frame: 8 weeks]
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Secondary Outcome(s)
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Changes in Harvey Bradshaw index in subjects with Crohn's disease
[Time Frame: 8 weeks]
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Changes in DAS-28 CRP score in subjects with rheumatoid arthritis
[Time Frame: 8 weeks]
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Changes in markers of intestinal inflammation (faecal calprotectin) that occur with exercise
[Time Frame: 8 weeks]
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Changes in fecal bile acids
[Time Frame: 8 weeks]
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Impact of medium-term moderate intensity exercise on resting inflammatory profiles (cytokines) in these patients.
[Time Frame: 8 weeks]
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Changes in Predicted VO2 max via 1-mile walk test (Rockport test)
[Time Frame: 8 weeks]
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Alterations in gut microbiota
[Time Frame: 8 weeks]
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Changes in Powell tuck score in subjects with ulcerative colitis
[Time Frame: 8 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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