Clinical Trials Directory

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

TypeNameDescription
OTHERExerciseExercise 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.
OTHERDietary planMediterranean dietary plan, which contains foods, such as fish, vegetables, nuts, and oils, which are anti-inflammatory in nature.
OTHERStretchingStretching 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.