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Clinical Trials/NCT02945488
NCT02945488TerminatedNot Applicable

Exercise and Nutrition as Treatment Alternatives in Women With Inflammatory Bowel Disease During Preconception: Saskatchewan Multidisciplinary Inflammatory Bowel Diseases Clinic (MDIBDC)

University of Saskatchewan2 sites in 1 country3 target enrollmentStarted: August 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
3
Locations
2
Primary Endpoint
Change from Baseline Inflammatory Bowel Disease Questionnaire score

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Arms & Interventions

Exercise and dietary plan

Experimental

Combination cardiovascular and resistance training and Mediterranean dietary plan

Intervention: Exercise (Other)

Exercise and dietary plan

Experimental

Combination cardiovascular and resistance training and Mediterranean dietary plan

Intervention: Dietary plan (Other)

Exercise and no dietary plan

Experimental

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

Intervention: Exercise (Other)

Stretching and dietary plan

Experimental

Flexibility training (control exercise) and Mediterranean dietary plan

Intervention: Dietary plan (Other)

Stretching and dietary plan

Experimental

Flexibility training (control exercise) and Mediterranean dietary plan

Intervention: Stretching (Other)

Stretching and no dietary plan

Active Comparator

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

Intervention: Stretching (Other)

Outcomes

Primary Outcomes

Change from Baseline Inflammatory Bowel Disease Questionnaire score

Time Frame: Baseline, 3 months, and 6 months

Inflammatory Bowel Disease Questionnaire (score on a scale); measures quality of life

Secondary Outcomes

  • Change from Baseline in Body Composition(Baseline, 3 months, and 6 months)
  • Change from Baseline in Femoral Neck Bone Mineral Density(Baseline, 3 months, and 6 months)
  • Change from Baseline Protein Consumption(Baseline, 3 months, and 6 months)
  • Change from Baseline in Estradiol(Baseline, 3 months, and 6 months)
  • Change from Baseline in Harvey Bradshaw Index(Baseline, 3 months, and 6 months)
  • Change from Baseline Fat Consumption(Baseline, 3 months, and 6 months)
  • Change from Baseline Interleukin-6(Baseline, 3 months, and 6 months)
  • Change from Baseline in Follicle Stimulating Hormone(Baseline, 3 months, and 6 months)
  • Change from Baseline in Leisure Time Physical Activity Questionnaire score(Baseline, 3 months, and 6 months)
  • Change from Baseline in Total Body Lean Mass(Baseline, 3 months, and 6 months)
  • Change from Baseline in Total Body Fat Mass(Baseline, 3 months, and 6 months)
  • Change from Baseline Fecal Calprotectin(Baseline, 3 months, and 6 months)
  • Change from Baseline Carbohydrate Consumption(Baseline, 3 months, and 6 months)
  • Change from Baseline EuroQol Five Dimensions Questionnaire (EQ-5D) score(Baseline, 3 months, and 6 months)
  • Change from Baseline in Total Body Bone Mineral Density(Baseline, 3 months, and 6 months)
  • Change from Baseline in partial Mayo Score(Baseline, 3 months, and 6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sharyle Fowler

M.D.

University of Saskatchewan

Study Sites (2)

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