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Exercise and Nutrition in IBD & Preconception (IBDPreconcep)

Primary Purpose

Inflammatory Bowel Diseases

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Exercise
Dietary plan
Stretching
Sponsored by
University of Saskatchewan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Bowel Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Royal University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Exercise and dietary plan

Exercise and no dietary plan

Stretching and dietary plan

Stretching and no dietary plan

Arm Description

Combination cardiovascular and resistance training and Mediterranean dietary plan

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

Flexibility training (control exercise) and Mediterranean dietary plan

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from Baseline Interleukin-6
Serum Interleukin-6 (pg/mL); measures inflammation
Change from Baseline in Follicle Stimulating Hormone
Serum Follicle Stimulating Hormone (mIU/ml); measures fertility status
Change from Baseline in Leisure Time Physical Activity Questionnaire score
Leisure Time Physical Activity Questionnaire (arbitrary score); measures physical activity levels outside intervention
Change from Baseline in Estradiol
Serum estradiol (pg/mL); measures fertility status
Change from Baseline in Total Body Lean Mass
Total body lean mass (grams) via dual energy x-ray absorptiometry scan; measures body composition
Change from Baseline in Total Body Fat Mass
Total body fat mass (grams) via dual energy x-ray absorptiometry scan; measures body composition
Change from Baseline in Body Composition
Body fat percentage (%) via dual energy x-ray absorptiometry scan; measures body composition
Change from Baseline in Femoral Neck Bone Mineral Density
Femoral neck bone mineral density (g/cm^2) via dual energy x-ray absorptiometry scan; measures bone health
Change from Baseline in Total Body Bone Mineral Density
Total body bone mineral density (g/cm^2) via dual energy x-ray absorptiometry scan; measure bone health
Change from Baseline in Harvey Bradshaw Index
Harvey Bradshaw Index for Crohn's disease (score on a scale); measures clinical disease activity
Change from Baseline in partial Mayo Score
Partial Mayo Score for ulcerative colitis (score on a scale); measures clinical disease activity
Change from Baseline Fecal Calprotectin
Fecal calprotectin (mg/kg); measures clinical disease activity
Change from Baseline Protein Consumption
Food Frequency Questionnaire average protein consumption per day (grams); measures nutritional status
Change from Baseline Carbohydrate Consumption
Food Frequency Questionnaire average carbohydrate consumption per day (grams); measures nutritional status
Change from Baseline Fat Consumption
Food Frequency Questionnaire average fat consumption per day (grams); measures nutritional status
Change from Baseline EuroQol Five Dimensions Questionnaire (EQ-5D) score
The EQ-5D (score on a scale); measures quality of life

Full Information

First Posted
September 27, 2016
Last Updated
June 11, 2018
Sponsor
University of Saskatchewan
Collaborators
Saskatchewan Health Research Foundation, Crohn's and Colitis Canada
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1. Study Identification

Unique Protocol Identification Number
NCT02945488
Brief Title
Exercise and Nutrition in IBD & Preconception
Acronym
IBDPreconcep
Official Title
Exercise and Nutrition as Treatment Alternatives in Women With Inflammatory Bowel Disease During Preconception: Saskatchewan Multidisciplinary Inflammatory Bowel Diseases Clinic (MDIBDC)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Terminated
Study Start Date
August 2016 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Saskatchewan
Collaborators
Saskatchewan Health Research Foundation, Crohn's and Colitis Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise and dietary plan
Arm Type
Experimental
Arm Description
Combination cardiovascular and resistance training and Mediterranean dietary plan
Arm Title
Exercise and no dietary plan
Arm Type
Experimental
Arm Description
Combination cardiovascular and resistance training and participants regular diet (control diet)
Arm Title
Stretching and dietary plan
Arm Type
Experimental
Arm Description
Flexibility training (control exercise) and Mediterranean dietary plan
Arm Title
Stretching and no dietary plan
Arm Type
Active Comparator
Arm Description
Flexibility training (control exercise) and participants regular diet (control diet)
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
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
Intervention Name(s)
Dietary plan
Intervention Description
Mediterranean dietary plan, which contains foods, such as fish, vegetables, nuts, and oils, which are anti-inflammatory in nature.
Intervention Type
Other
Intervention Name(s)
Stretching
Intervention Description
Stretching intervention will entail 30 minutes of flexibility training 3 days/week of stretches targeting all major muscle groups held for 20-30 seconds.
Primary Outcome Measure Information:
Title
Change from Baseline Inflammatory Bowel Disease Questionnaire score
Description
Inflammatory Bowel Disease Questionnaire (score on a scale); measures quality of life
Time Frame
Baseline, 3 months, and 6 months
Secondary Outcome Measure Information:
Title
Change from Baseline Interleukin-6
Description
Serum Interleukin-6 (pg/mL); measures inflammation
Time Frame
Baseline, 3 months, and 6 months
Title
Change from Baseline in Follicle Stimulating Hormone
Description
Serum Follicle Stimulating Hormone (mIU/ml); measures fertility status
Time Frame
Baseline, 3 months, and 6 months
Title
Change from Baseline in Leisure Time Physical Activity Questionnaire score
Description
Leisure Time Physical Activity Questionnaire (arbitrary score); measures physical activity levels outside intervention
Time Frame
Baseline, 3 months, and 6 months
Title
Change from Baseline in Estradiol
Description
Serum estradiol (pg/mL); measures fertility status
Time Frame
Baseline, 3 months, and 6 months
Title
Change from Baseline in Total Body Lean Mass
Description
Total body lean mass (grams) via dual energy x-ray absorptiometry scan; measures body composition
Time Frame
Baseline, 3 months, and 6 months
Title
Change from Baseline in Total Body Fat Mass
Description
Total body fat mass (grams) via dual energy x-ray absorptiometry scan; measures body composition
Time Frame
Baseline, 3 months, and 6 months
Title
Change from Baseline in Body Composition
Description
Body fat percentage (%) via dual energy x-ray absorptiometry scan; measures body composition
Time Frame
Baseline, 3 months, and 6 months
Title
Change from Baseline in Femoral Neck Bone Mineral Density
Description
Femoral neck bone mineral density (g/cm^2) via dual energy x-ray absorptiometry scan; measures bone health
Time Frame
Baseline, 3 months, and 6 months
Title
Change from Baseline in Total Body Bone Mineral Density
Description
Total body bone mineral density (g/cm^2) via dual energy x-ray absorptiometry scan; measure bone health
Time Frame
Baseline, 3 months, and 6 months
Title
Change from Baseline in Harvey Bradshaw Index
Description
Harvey Bradshaw Index for Crohn's disease (score on a scale); measures clinical disease activity
Time Frame
Baseline, 3 months, and 6 months
Title
Change from Baseline in partial Mayo Score
Description
Partial Mayo Score for ulcerative colitis (score on a scale); measures clinical disease activity
Time Frame
Baseline, 3 months, and 6 months
Title
Change from Baseline Fecal Calprotectin
Description
Fecal calprotectin (mg/kg); measures clinical disease activity
Time Frame
Baseline, 3 months, and 6 months
Title
Change from Baseline Protein Consumption
Description
Food Frequency Questionnaire average protein consumption per day (grams); measures nutritional status
Time Frame
Baseline, 3 months, and 6 months
Title
Change from Baseline Carbohydrate Consumption
Description
Food Frequency Questionnaire average carbohydrate consumption per day (grams); measures nutritional status
Time Frame
Baseline, 3 months, and 6 months
Title
Change from Baseline Fat Consumption
Description
Food Frequency Questionnaire average fat consumption per day (grams); measures nutritional status
Time Frame
Baseline, 3 months, and 6 months
Title
Change from Baseline EuroQol Five Dimensions Questionnaire (EQ-5D) score
Description
The EQ-5D (score on a scale); measures quality of life
Time Frame
Baseline, 3 months, and 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharyle Fowler, MD
Organizational Affiliation
University of Saskatchewan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal University Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Exercise and Nutrition in IBD & Preconception

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