Exercise and Nutrition in IBD & Preconception

NCT ID: NCT02945488

Last Updated: 2018-06-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2017-09-30

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.

Conditions

Inflammatory Bowel Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exercise and dietary plan

Combination cardiovascular and resistance training and Mediterranean dietary plan

Group Type: EXPERIMENTAL

Exercise

Intervention Type: 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.

Dietary plan

Intervention Type: OTHER

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

Exercise and no dietary plan

Combination cardiovascular and resistance training and participants regular diet (control diet)

Group Type: EXPERIMENTAL

Exercise

Intervention Type: 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.

Stretching and dietary plan

Flexibility training (control exercise) and Mediterranean dietary plan

Group Type: EXPERIMENTAL

Dietary plan

Intervention Type: OTHER

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

Stretching

Intervention Type: 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.

Stretching and no dietary plan

Flexibility training (control exercise) and participants regular diet (control diet)

Group Type: ACTIVE_COMPARATOR

Stretching

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Dietary plan

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

Intervention Type: 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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Saskatchewan Health Research Foundation

OTHER

Sponsor Role: collaborator

Crohn's and Colitis Canada

OTHER

Sponsor Role: collaborator

University of Saskatchewan

OTHER

Sponsor Role: lead

Responsible Party

Sharyle Fowler

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sharyle Fowler, MD

Role: PRINCIPAL_INVESTIGATOR

University of Saskatchewan

Locations

Royal University Hospital

Saskatoon, Saskatchewan, Canada

Countries

Canada

Other Identifiers

16-132

Identifier Type: -

Identifier Source: org_study_id