Trials / Terminated
TerminatedNCT02945488
Exercise and Nutrition in IBD & Preconception
Exercise and Nutrition as Treatment Alternatives in Women With Inflammatory Bowel Disease During Preconception: Saskatchewan Multidisciplinary Inflammatory Bowel Diseases Clinic (MDIBDC)
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 3 (actual)
- Sponsor
- University of Saskatchewan · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| 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. |
Timeline
- Start date
- 2016-08-01
- Primary completion
- 2017-09-01
- Completion
- 2017-09-01
- First posted
- 2016-10-26
- Last updated
- 2018-06-13
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT02945488. Inclusion in this directory is not an endorsement.