Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Saskatchewan Health Research Foundation | OTHER |
| Crohn's and Colitis Canada | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise and dietary plan | Experimental | Combination cardiovascular and resistance training and Mediterranean dietary plan |
|
| Exercise and no dietary plan | Experimental | Combination cardiovascular and resistance training and participants regular diet (control diet) |
|
| Stretching and dietary plan | Experimental | Flexibility training (control exercise) and Mediterranean dietary plan |
|
| Stretching and no dietary plan | Active Comparator | Flexibility training (control exercise) and participants regular diet (control diet) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Inflammatory Bowel Disease Questionnaire score | Inflammatory Bowel Disease Questionnaire (score on a scale); measures quality of life | Baseline, 3 months, and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Interleukin-6 | Serum Interleukin-6 (pg/mL); measures inflammation | Baseline, 3 months, and 6 months |
| Change from Baseline in Follicle Stimulating Hormone | Serum Follicle Stimulating Hormone (mIU/ml); measures fertility status |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sharyle Fowler, MD | University of Saskatchewan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal University Hospital | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Dietary plan | Other | Mediterranean dietary plan, which contains foods, such as fish, vegetables, nuts, and oils, which are anti-inflammatory in nature. |
|
| Stretching | Other | Stretching intervention will entail 30 minutes of flexibility training 3 days/week of stretches targeting all major muscle groups held for 20-30 seconds. |
|
| Baseline, 3 months, and 6 months |
| Change from Baseline in Leisure Time Physical Activity Questionnaire score | Leisure Time Physical Activity Questionnaire (arbitrary score); measures physical activity levels outside intervention | Baseline, 3 months, and 6 months |
| Change from Baseline in Estradiol | Serum estradiol (pg/mL); measures fertility status | Baseline, 3 months, and 6 months |
| Change from Baseline in Total Body Lean Mass | Total body lean mass (grams) via dual energy x-ray absorptiometry scan; measures body composition | Baseline, 3 months, and 6 months |
| Change from Baseline in Total Body Fat Mass | Total body fat mass (grams) via dual energy x-ray absorptiometry scan; measures body composition | Baseline, 3 months, and 6 months |
| Change from Baseline in Body Composition | Body fat percentage (%) via dual energy x-ray absorptiometry scan; measures body composition | Baseline, 3 months, and 6 months |
| Change from Baseline in Femoral Neck Bone Mineral Density | Femoral neck bone mineral density (g/cm^2) via dual energy x-ray absorptiometry scan; measures bone health | Baseline, 3 months, and 6 months |
| Change from Baseline in Total Body Bone Mineral Density | Total body bone mineral density (g/cm^2) via dual energy x-ray absorptiometry scan; measure bone health | Baseline, 3 months, and 6 months |
| Change from Baseline in Harvey Bradshaw Index | Harvey Bradshaw Index for Crohn's disease (score on a scale); measures clinical disease activity | Baseline, 3 months, and 6 months |
| Change from Baseline in partial Mayo Score | Partial Mayo Score for ulcerative colitis (score on a scale); measures clinical disease activity | Baseline, 3 months, and 6 months |
| Change from Baseline Fecal Calprotectin | Fecal calprotectin (mg/kg); measures clinical disease activity | Baseline, 3 months, and 6 months |
| Change from Baseline Protein Consumption | Food Frequency Questionnaire average protein consumption per day (grams); measures nutritional status | Baseline, 3 months, and 6 months |
| Change from Baseline Carbohydrate Consumption | Food Frequency Questionnaire average carbohydrate consumption per day (grams); measures nutritional status | Baseline, 3 months, and 6 months |
| Change from Baseline Fat Consumption | Food Frequency Questionnaire average fat consumption per day (grams); measures nutritional status | Baseline, 3 months, and 6 months |
| Change from Baseline EuroQol Five Dimensions Questionnaire (EQ-5D) score | The EQ-5D (score on a scale); measures quality of life | Baseline, 3 months, and 6 months |