Exercise and Nutrition in IBD & Preconception (IBDPreconcep)

University of Saskatchewan

Status: Terminated

Conditions: Inflammatory Bowel Diseases

Treatments: Other: Stretching; Other: Exercise; Other: Dietary plan

Study type: Interventional

Funder types: Other

Identifiers

NCT02945488

16-132

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 4 patient groups

Exercise and dietary plan

Experimental group

Description:

Combination cardiovascular and resistance training and Mediterranean dietary plan

Treatment:

Other: Exercise

Other: Dietary plan

Exercise and no dietary plan

Experimental group

Description:

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

Treatment:

Other: Exercise

Stretching and dietary plan

Experimental group

Description:

Flexibility training (control exercise) and Mediterranean dietary plan

Treatment:

Other: Stretching

Other: Dietary plan

Stretching and no dietary plan

Active Comparator group

Description:

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

Treatment:

Other: Stretching