Exercise and Nutrition in IBD & Preconception

NCT02945488 | Terminated

• 1 other identifier: 16-132
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Inflammatory Bowel Disease Questionnaire score

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

  Baseline, 3 months, and 6 months

Secondary Outcomes (16)

• 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 Estradiol

  Baseline, 3 months, and 6 months

• Change from Baseline in Total Body Lean Mass

  Baseline, 3 months, and 6 months

Study Arms (4)

Exercise and dietary plan

EXPERIMENTAL

Combination cardiovascular and resistance training and Mediterranean dietary plan

Other: Exercise; Other: Dietary plan

Exercise and no dietary plan

EXPERIMENTAL

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

Other: Exercise

Stretching and dietary plan

EXPERIMENTAL

Flexibility training (control exercise) and Mediterranean dietary plan

Other: Dietary plan; Other: Stretching

Stretching and no dietary plan

ACTIVE COMPARATOR

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

Other: Stretching

Interventions

Exercise 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.

Exercise and dietary plan; Exercise and no dietary plan

Dietary plan OTHER

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

Exercise and dietary plan; Stretching and dietary plan

Stretching 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 dietary plan; Stretching and no dietary plan

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• Confirmed diagnosis of Inflammatory Bowel Disease
• Child-bearing age

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Saskatchewan: lead
• Saskatchewan Health Research Foundation: collaborator
• Crohn's and Colitis Canada: collaborator

Study Sites (1)

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Sharyle Fowler, MD

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: September 27, 2016
• First Posted: October 26, 2016
• Study Start: August 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: June 13, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)