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Exercise and Nutrition in IBD & Preconception (IBDPreconcep)

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ClinicalTrials.gov Identifier: NCT02945488
Recruitment Status : Terminated
First Posted : October 26, 2016
Last Update Posted : June 13, 2018
Sponsor:
Collaborators:
Saskatchewan Health Research Foundation
Crohn's and Colitis Canada
Information provided by (Responsible Party):
Sharyle Fowler, University of Saskatchewan

Brief Summary:
The objectives are to: 1) Assess the independent and synergistic efficacy of exercise and nutrition interventions to manage major symptomatic concerns of inflammatory bowel diseases (IBD), 2) Assess the independent and synergistic efficacy of exercise and nutrition to mitigate inflammation in IBD, and 3) Assess the feasibility of such an intervention in preconception women with IBD. The investigators hypothesize that the combination of anti-inflammatory exercise and nutritional interventions will have a synergistic effect on managing major symptomatic concerns associated with IBD, reducing inflammation, and improving fertility status in preconception women with IBD, as compared to either intervention independently.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Diseases Other: Exercise Other: Dietary plan Other: Stretching Not Applicable

Detailed Description:
Potential participants will be recruited from the Preconception and Pregnancy Clinic recently established within the Saskatchewan Multidisciplinary Inflammatory Bowel Disease Clinic [MDIBDC]. Eligible participants will be randomized [stratified] to one of four groups: 1) Exercise and dietary plan, 2) Exercise and no dietary plan, 3) Stretching [placebo exercise] and dietary plan, 4) Stretching and no dietary plan. Participants will be assessed at baseline, midway [3 months], and post-intervention [6 months] for indications of disease activity, quality of life, fertility status, and bone health.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exercise and Nutrition as Treatment Alternatives in Women With Inflammatory Bowel Disease During Preconception: Saskatchewan Multidisciplinary Inflammatory Bowel Diseases Clinic (MDIBDC)
Actual Study Start Date : August 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise and dietary plan
Combination cardiovascular and resistance training and Mediterranean dietary plan
Other: Exercise
Exercise intervention will entail 30 minutes of moderate intensity cardiovascular training 3 days/week and full body resistance training 2 days/week (supervised). Cardiovascular training will entail any weight-bearing activity that would achieve target heart rate, such as walking, jogging, stair climbing, dancing, etc. Resistance training will entail 2-3 sets of 8-12 repetitions of exercises targeting all major muscle groups with an external load applied, such as a dumbbell, barbell, medicine ball, etc.

Other: Dietary plan
Mediterranean dietary plan, which contains foods, such as fish, vegetables, nuts, and oils, which are anti-inflammatory in nature.

Experimental: Exercise and no dietary plan
Combination cardiovascular and resistance training and participants regular diet (control diet)
Other: Exercise
Exercise intervention will entail 30 minutes of moderate intensity cardiovascular training 3 days/week and full body resistance training 2 days/week (supervised). Cardiovascular training will entail any weight-bearing activity that would achieve target heart rate, such as walking, jogging, stair climbing, dancing, etc. Resistance training will entail 2-3 sets of 8-12 repetitions of exercises targeting all major muscle groups with an external load applied, such as a dumbbell, barbell, medicine ball, etc.

Experimental: Stretching and dietary plan
Flexibility training (control exercise) and Mediterranean dietary plan
Other: Dietary plan
Mediterranean dietary plan, which contains foods, such as fish, vegetables, nuts, and oils, which are anti-inflammatory in nature.

Other: Stretching
Stretching intervention will entail 30 minutes of flexibility training 3 days/week of stretches targeting all major muscle groups held for 20-30 seconds.

Active Comparator: Stretching and no dietary plan
Flexibility training (control exercise) and participants regular diet (control diet)
Other: Stretching
Stretching intervention will entail 30 minutes of flexibility training 3 days/week of stretches targeting all major muscle groups held for 20-30 seconds.




Primary Outcome Measures :
  1. Change from Baseline Inflammatory Bowel Disease Questionnaire score [ Time Frame: Baseline, 3 months, and 6 months ]
    Inflammatory Bowel Disease Questionnaire (score on a scale); measures quality of life


Secondary Outcome Measures :
  1. Change from Baseline Interleukin-6 [ Time Frame: Baseline, 3 months, and 6 months ]
    Serum Interleukin-6 (pg/mL); measures inflammation

  2. Change from Baseline in Follicle Stimulating Hormone [ Time Frame: Baseline, 3 months, and 6 months ]
    Serum Follicle Stimulating Hormone (mIU/ml); measures fertility status

  3. Change from Baseline in Leisure Time Physical Activity Questionnaire score [ Time Frame: Baseline, 3 months, and 6 months ]
    Leisure Time Physical Activity Questionnaire (arbitrary score); measures physical activity levels outside intervention

  4. Change from Baseline in Estradiol [ Time Frame: Baseline, 3 months, and 6 months ]
    Serum estradiol (pg/mL); measures fertility status

  5. Change from Baseline in Total Body Lean Mass [ Time Frame: Baseline, 3 months, and 6 months ]
    Total body lean mass (grams) via dual energy x-ray absorptiometry scan; measures body composition

  6. Change from Baseline in Total Body Fat Mass [ Time Frame: Baseline, 3 months, and 6 months ]
    Total body fat mass (grams) via dual energy x-ray absorptiometry scan; measures body composition

  7. Change from Baseline in Body Composition [ Time Frame: Baseline, 3 months, and 6 months ]
    Body fat percentage (%) via dual energy x-ray absorptiometry scan; measures body composition

  8. Change from Baseline in Femoral Neck Bone Mineral Density [ Time Frame: Baseline, 3 months, and 6 months ]
    Femoral neck bone mineral density (g/cm^2) via dual energy x-ray absorptiometry scan; measures bone health

  9. Change from Baseline in Total Body Bone Mineral Density [ Time Frame: Baseline, 3 months, and 6 months ]
    Total body bone mineral density (g/cm^2) via dual energy x-ray absorptiometry scan; measure bone health

  10. Change from Baseline in Harvey Bradshaw Index [ Time Frame: Baseline, 3 months, and 6 months ]
    Harvey Bradshaw Index for Crohn's disease (score on a scale); measures clinical disease activity

  11. Change from Baseline in partial Mayo Score [ Time Frame: Baseline, 3 months, and 6 months ]
    Partial Mayo Score for ulcerative colitis (score on a scale); measures clinical disease activity

  12. Change from Baseline Fecal Calprotectin [ Time Frame: Baseline, 3 months, and 6 months ]
    Fecal calprotectin (mg/kg); measures clinical disease activity

  13. Change from Baseline Protein Consumption [ Time Frame: Baseline, 3 months, and 6 months ]
    Food Frequency Questionnaire average protein consumption per day (grams); measures nutritional status

  14. Change from Baseline Carbohydrate Consumption [ Time Frame: Baseline, 3 months, and 6 months ]
    Food Frequency Questionnaire average carbohydrate consumption per day (grams); measures nutritional status

  15. Change from Baseline Fat Consumption [ Time Frame: Baseline, 3 months, and 6 months ]
    Food Frequency Questionnaire average fat consumption per day (grams); measures nutritional status

  16. Change from Baseline EuroQol Five Dimensions Questionnaire (EQ-5D) score [ Time Frame: Baseline, 3 months, and 6 months ]
    The EQ-5D (score on a scale); measures quality of life



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female
  • Confirmed diagnosis of Inflammatory Bowel Disease
  • Child-bearing age

Exclusion Criteria:

  • Currently following a Mediterranean diet
  • Currently performing resistance training on a regular basis (within the past 6 months)
  • Failed Physical Activity Readiness Questionnaire-Plus (PAR-Q+).
  • Past ileal pouch anal anastomosis
  • Unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise subject safety

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): NCT02945488


Locations
Canada, Saskatchewan
Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8
Sponsors and Collaborators
University of Saskatchewan
Saskatchewan Health Research Foundation
Crohn's and Colitis Canada
Investigators
Principal Investigator: Sharyle Fowler, MD University of Saskatchewan

Responsible Party: Sharyle Fowler, M.D., University of Saskatchewan
ClinicalTrials.gov Identifier: NCT02945488     History of Changes
Other Study ID Numbers: 16-132
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis