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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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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
Sponsor:
Information provided by (Responsible Party):
Professor Fergus Shanahan, University College Cork

Brief Summary:
The purpose of this study is too determine the effects of exercise on the gut microbiota and immunological markers in patients with inflammatory bowel disease and rheumatoid arthritis.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Disease Rheumatoid Arthritis Other: Exercise Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Immediate exercise
This group will immediately commence an 8 week exercise programme.
Other: Exercise
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.
Other: Exercise
8 week structured exercise programme




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Changes in fecal bile acids [ Time Frame: 8 weeks ]
    Patinets fecal bile acids will be measured pre and post intervention

  2. 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

  3. 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)

  4. Impact of medium-term moderate intensity exercise on resting inflammatory profiles (cytokines) in these patients. [ Time Frame: 8 weeks ]
  5. 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.

  6. 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

  7. 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.

  8. 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.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Owen Cronin, MB BAO BCH owen.cronin@hotmail.com
Contact: Donal Sheehan, MB BAO BCH donal.sheehan@ucc.ie

Locations
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Ireland
Alimentary Pharmabiotic Centre, University College Cork Recruiting
Cork, Ireland
Contact: Susan Rafferty - McArdle, PhD       s.rafferty@ucc.ie   
Sponsors and Collaborators
University College Cork
Investigators
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Principal Investigator: Fergus Shanahan, MD, DSc. Professor and Chair Dept. of Medicine, University College Cork

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Professor Fergus Shanahan, Professor and Chair Department of Medicine and Director Alimentary Pharmabiotic Centre, University College Cork, University College Cork
ClinicalTrials.gov Identifier: NCT02463916     History of Changes
Other Study ID Numbers: APC056
First Posted: June 4, 2015    Key Record Dates
Last Update Posted: June 4, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Intestinal Diseases
Inflammatory Bowel Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis