Inflammatory Bowel DiseasesIBDPreconcepNCT02945488
Exercise and Nutrition in IBD & Preconception
A study testing Exercise, Dietary plan and Stretching in people with Inflammatory Bowel Diseases, run by University of Saskatchewan at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Exercise, Dietary plan and Stretching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2016to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Confirmed diagnosis of Inflammatory Bowel Disease
- Child-bearing age
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Exercise and Nutrition as Treatment Alternatives in Women With Inflammatory Bowel Disease During Preconception: Saskatchewan Multidisciplinary Inflammatory Bowel Diseases Clinic (MDIBDC)
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.
Read the 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
- Being tested
- Exercise, Dietary plan, Stretching
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
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 planOther
Mediterranean dietary plan, which contains foods, such as fish, vegetables, nuts, and oils, which are anti-inflammatory in nature.
StretchingOther
Stretching intervention will entail 30 minutes of flexibility training 3 days/week of stretches targeting all major muscle groups held for 20-30 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Exercise and dietary plan | Experimental | Combination cardiovascular and resistance training and Mediterranean dietary plan Receives: Other: Exercise; Other: Dietary plan |
| Exercise and no dietary plan | Experimental | Combination cardiovascular and resistance training and participants regular diet (control diet) Receives: Other: Exercise |
| Stretching and dietary plan | Experimental | Flexibility training (control exercise) and Mediterranean dietary plan Receives: Other: Dietary plan; Other: Stretching |
| Stretching and no dietary plan | Active comparator | Flexibility training (control exercise) and participants regular diet (control diet) Receives: Other: Stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Inflammatory Bowel Disease Questionnaire score
Inflammatory Bowel Disease Questionnaire (score on a scale); measures quality of life
Measured: Baseline, 3 months, and 6 months
Secondary outcomes (16)
Change from Baseline Interleukin-6
Serum Interleukin-6 (pg/mL); measures inflammation
Measured: Baseline, 3 months, and 6 months
Change from Baseline in Follicle Stimulating Hormone
Serum Follicle Stimulating Hormone (mIU/ml); measures fertility status
Measured: Baseline, 3 months, and 6 months
Change from Baseline in Leisure Time Physical Activity Questionnaire score
Leisure Time Physical Activity Questionnaire (arbitrary score); measures physical activity levels outside intervention
Measured: Baseline, 3 months, and 6 months
Change from Baseline in Estradiol
Serum estradiol (pg/mL); measures fertility status
Measured: Baseline, 3 months, and 6 months
Change from Baseline in Total Body Lean Mass
Total body lean mass (grams) via dual energy x-ray absorptiometry scan; measures body composition
Measured: Baseline, 3 months, and 6 months
Change from Baseline in Total Body Fat Mass
Total body fat mass (grams) via dual energy x-ray absorptiometry scan; measures body composition
Measured: Baseline, 3 months, and 6 months
Change from Baseline in Body Composition
Body fat percentage (%) via dual energy x-ray absorptiometry scan; measures body composition
Measured: Baseline, 3 months, and 6 months
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
Measured: Baseline, 3 months, and 6 months
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
Measured: Baseline, 3 months, and 6 months
Change from Baseline in Harvey Bradshaw Index
Harvey Bradshaw Index for Crohn's disease (score on a scale); measures clinical disease activity
Measured: Baseline, 3 months, and 6 months
Change from Baseline in partial Mayo Score
Partial Mayo Score for ulcerative colitis (score on a scale); measures clinical disease activity
Measured: Baseline, 3 months, and 6 months
Change from Baseline Fecal Calprotectin
Fecal calprotectin (mg/kg); measures clinical disease activity
Measured: Baseline, 3 months, and 6 months
Change from Baseline Protein Consumption
Food Frequency Questionnaire average protein consumption per day (grams); measures nutritional status
Measured: Baseline, 3 months, and 6 months
Change from Baseline Carbohydrate Consumption
Food Frequency Questionnaire average carbohydrate consumption per day (grams); measures nutritional status
Measured: Baseline, 3 months, and 6 months
Change from Baseline Fat Consumption
Food Frequency Questionnaire average fat consumption per day (grams); measures nutritional status
Measured: Baseline, 3 months, and 6 months
Change from Baseline EuroQol Five Dimensions Questionnaire (EQ-5D) score
The EQ-5D (score on a scale); measures quality of life
Measured: Baseline, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study startAug 2016
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Saskatchewan Health Research Foundation, Crohn's and Colitis Canada
- Responsible party
- Principal investigator, Sharyle Fowler, University of Saskatchewan
- Investigators
- Sharyle Fowler, MD, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02945488
- Sponsor's protocol ID
- 16-132
- Acronym
- IBDPreconcep
- Status last verified
- Jun 2018
- First submitted
- 27 Sep 2016
- Last updated
- 13 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise and Nutrition as Treatment Alternatives in Women With Inflammatory Bowel Disease During Preconception: Saskatchewan Multidisciplinary Inflammatory Bowel Diseases Clinic (MDIBDC)
- ClinicalTrials.gov ID
- NCT02945488
- Acronym / sponsor ID
- IBDPreconcep / 16-132
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Saskatchewan Health Research Foundation, Crohn's and Colitis Canada
- Study start
- Aug 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 26 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Exercise and dietary plan | Experimental | Other: Exercise, Other: Dietary planCombination cardiovascular and resistance training and Mediterranean dietary plan |
| Exercise and no dietary plan | Experimental | Other: ExerciseCombination cardiovascular and resistance training and participants regular diet (control diet) |
| Stretching and dietary plan | Experimental | Other: Dietary plan, Other: StretchingFlexibility training (control exercise) and Mediterranean dietary plan |
| Stretching and no dietary plan | Active comparator | Other: StretchingFlexibility training (control exercise) and participants regular diet (control diet) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female
- Confirmed diagnosis of Inflammatory Bowel Disease
- Child-bearing age
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseExercise 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. | Other | Exercise and dietary plan, Exercise and no dietary plan |
| Dietary planMediterranean dietary plan, which contains foods, such as fish, vegetables, nuts, and oils, which are anti-inflammatory in nature. | Other | Exercise and dietary plan, Stretching and dietary plan |
| StretchingStretching intervention will entail 30 minutes of flexibility training 3 days/week of stretches targeting all major muscle groups held for 20-30 seconds. | Other | Stretching and dietary plan, Stretching and no dietary plan |
Primary outcome
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
16 secondary outcomes
Change from Baseline Interleukin-6
Time frame: Baseline, 3 months, and 6 months
Change from Baseline in Follicle Stimulating Hormone
Time frame: Baseline, 3 months, and 6 months
Change from Baseline in Leisure Time Physical Activity Questionnaire score
Time frame: Baseline, 3 months, and 6 months
Change from Baseline in Estradiol
Time frame: Baseline, 3 months, and 6 months
Change from Baseline in Total Body Lean Mass
Time frame: Baseline, 3 months, and 6 months
Change from Baseline in Total Body Fat Mass
Time frame: Baseline, 3 months, and 6 months
Change from Baseline in Body Composition
Time frame: Baseline, 3 months, and 6 months
Change from Baseline in Femoral Neck Bone Mineral Density
Time frame: Baseline, 3 months, and 6 months
Change from Baseline in Total Body Bone Mineral Density
Time frame: Baseline, 3 months, and 6 months
Change from Baseline in Harvey Bradshaw Index
Time frame: Baseline, 3 months, and 6 months
Change from Baseline in partial Mayo Score
Time frame: Baseline, 3 months, and 6 months
Change from Baseline Fecal Calprotectin
Time frame: Baseline, 3 months, and 6 months
Change from Baseline Protein Consumption
Time frame: Baseline, 3 months, and 6 months
Change from Baseline Carbohydrate Consumption
Time frame: Baseline, 3 months, and 6 months
Change from Baseline Fat Consumption
Time frame: Baseline, 3 months, and 6 months
Change from Baseline EuroQol Five Dimensions Questionnaire (EQ-5D) score
Time frame: Baseline, 3 months, and 6 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharyle Fowler, MD principal investigator
University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise, Dietary plan and Stretching in people with Inflammatory Bowel Diseases, run by University of Saskatchewan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Inflammatory Bowel Disease Questionnaire score (time frame: Baseline, 3 months, and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2018.