Exercise and Nutrition in IBD & Preconception
- Conditions
- Inflammatory Bowel Diseases
- Interventions
- Other: ExerciseOther: StretchingOther: Dietary plan
- Registration Number
- NCT02945488
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 3
- Female
- Confirmed diagnosis of Inflammatory Bowel Disease
- Child-bearing age
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exercise and dietary plan Exercise Combination cardiovascular and resistance training and Mediterranean dietary plan Exercise and dietary plan Dietary plan Combination cardiovascular and resistance training and Mediterranean dietary plan Stretching and no dietary plan Stretching Flexibility training (control exercise) and participants regular diet (control diet) Exercise and no dietary plan Exercise Combination cardiovascular and resistance training and participants regular diet (control diet) Stretching and dietary plan Dietary plan Flexibility training (control exercise) and Mediterranean dietary plan Stretching and dietary plan Stretching Flexibility training (control exercise) and Mediterranean dietary plan
- Primary Outcome Measures
Name Time Method Change from Baseline Inflammatory Bowel Disease Questionnaire score Baseline, 3 months, and 6 months Inflammatory Bowel Disease Questionnaire (score on a scale); measures quality of life
- Secondary Outcome Measures
Name Time Method Change from Baseline in Body Composition Baseline, 3 months, and 6 months Body fat percentage (%) via dual energy x-ray absorptiometry scan; measures body composition
Change from Baseline in Femoral Neck Bone Mineral Density Baseline, 3 months, and 6 months Femoral neck bone mineral density (g/cm\^2) via dual energy x-ray absorptiometry scan; measures bone health
Change from Baseline Protein Consumption Baseline, 3 months, and 6 months Food Frequency Questionnaire average protein consumption per day (grams); measures nutritional status
Change from Baseline in Estradiol Baseline, 3 months, and 6 months Serum estradiol (pg/mL); measures fertility status
Change from Baseline in Harvey Bradshaw Index Baseline, 3 months, and 6 months Harvey Bradshaw Index for Crohn's disease (score on a scale); measures clinical disease activity
Change from Baseline Fat Consumption Baseline, 3 months, and 6 months Food Frequency Questionnaire average fat consumption per day (grams); measures nutritional status
Change from Baseline in Total Body Bone Mineral Density Baseline, 3 months, and 6 months Total body bone mineral density (g/cm\^2) via dual energy x-ray absorptiometry scan; measure bone health
Change from Baseline Interleukin-6 Baseline, 3 months, and 6 months Serum Interleukin-6 (pg/mL); measures inflammation
Change from Baseline in Follicle Stimulating Hormone Baseline, 3 months, and 6 months Serum Follicle Stimulating Hormone (mIU/ml); measures fertility status
Change from Baseline in Leisure Time Physical Activity Questionnaire score Baseline, 3 months, and 6 months Leisure Time Physical Activity Questionnaire (arbitrary score); measures physical activity levels outside intervention
Change from Baseline in Total Body Lean Mass Baseline, 3 months, and 6 months Total body lean mass (grams) via dual energy x-ray absorptiometry scan; measures body composition
Change from Baseline in Total Body Fat Mass Baseline, 3 months, and 6 months Total body fat mass (grams) via dual energy x-ray absorptiometry scan; measures body composition
Change from Baseline Fecal Calprotectin Baseline, 3 months, and 6 months Fecal calprotectin (mg/kg); measures clinical disease activity
Change from Baseline Carbohydrate Consumption Baseline, 3 months, and 6 months Food Frequency Questionnaire average carbohydrate consumption per day (grams); measures nutritional status
Change from Baseline EuroQol Five Dimensions Questionnaire (EQ-5D) score Baseline, 3 months, and 6 months The EQ-5D (score on a scale); measures quality of life
Change from Baseline in partial Mayo Score Baseline, 3 months, and 6 months Partial Mayo Score for ulcerative colitis (score on a scale); measures clinical disease activity
Trial Locations
- Locations (1)
Royal University Hospital
🇨🇦Saskatoon, Saskatchewan, Canada