- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02628275
Impact of Mild or Moderate Physical Activity and Progression of Subclinical Atherosclerosis (MoMA)
Will Mild vs. Moderate Physical Activity Suffice to Abate the Progression of Subclinical Atherosclerosis in Sedentary Adults?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Cardiovascular disease (CVD) remains rampant in developed regions, topping the list of causes of mortality leading to 29% of all deaths. In addition to mortality, the economic impact of morbidity and hospitalization related to CVD costs Canadians over $22.2 billion every year. By far the leading cause of CVD is atherosclerosis defined as a thickening of the arterial wall with fatty deposits. Therefore, atherosclerosis is the underlying mechanism behind the #1 cause of mortality and morbidity in developed regions. Autopsy studies performed in healthy casualties of the Korean, Vietnam, Iraq and Afghanistan Wars revealed that atherosclerosis is present in up to 78% of young men before their 30th birthday, even in the absence of traditional risk factors (high blood pressure, dyslipidemia, obesity). Prevention of atherosclerosis and its silent progression towards clinical events decades later should therefore become a priority in all young adults. A potentially powerful avenue of cardiovascular prevention lies in the reduction of subclinical atherosclerosis progression in younger adults through physical activity. Unfortunately, only 15% of Canadians meet the current recommendations for 150min/week of moderate- to vigorous-intensity physical activity (MVPA). In response to the observation that Canadians simply don't find time for/or do not appear to value current recommendations, it was suggested that even light-intensity physical activity (LPA) might improve biomarker levels compared to a sedentary lifestyle. It appears that in the face of failed attempts to convince Canadians to perform 150min/week of MVPA, expectations towards LPA have been lowered despite the absence of convincing data.
MoMA is a randomized controlled trial to study the effects of two doses of physical activity on subclinical atherosclerosis burden progression; 270 inactive men and women aged 18-40 years without CVD or risk factors will be enrolled. At baseline, risk factors, physical activity level and nutritional habits will be measured through validated questionnaires; blood work and anthropometric parameters measurements will be performed (markers of cardiometabolic risk); fitness level will be assessed through treadmill test and accelerometer; magnetic resonance imaging of carotid atherosclerosis, liver and adipose tissue will be performed.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Johanne Marin
- Phone Number: 3286 418-656-8711
- Email: johanne.marin@criucpq.ulaval.ca
Study Locations
-
-
-
Québec, Canada, G1V 4G5
- Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Inactivity during leisure time as assessed through the long version of the International Physical Activity Questionnaire;
- Apparent health defined as 1) no known CVD (coronary, cerebrovascular or peripheral vascular disease), and 2) no known cardiovascular risk factors or cardiovascular medications (hypertension, dyslipidemia, diabetes, active smoking within past year, or clinical obesity defined as body mass index (BMI) ≥ 30kg/m2);
- Signed consent form.
Exclusion Criteria:
- Known dyslipidemia (participants receiving lipid-lowering medication, or in the absence of such medication, having: a fasting total plasma cholesterol level > 6.2 mmol/L, a triglyceride level ≥ 1.7 mmol/L, and/or HDL-cholesterol level < 1.0 mmol/L in men and < 1.3 mmol/L in women);
- Hypertension (participants receiving antihypertensive medications or having blood pressure ≥ 135/85 mmHg);
- Diabetes (participants taking diabetes medication or having plasma HbA1c ≥ 6.5%);
- Postmenopausal women;
- Pregnancy or nursing in the past year or expected in the next two years;
- Contraindications to MRI, as per the standardized IUCPQ MRI screening form;
- Participation in another research study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Continued inactivity
|
|
Active Comparator: Moderate to vigorous physical activity
MVPA (55-90% of maximum heart rate) for 150 min/week (current recommendations)
|
55-90% maximum heart rate for 150min/week (current recommendations)
|
Active Comparator: Light physical activity
LPA (40-55% of maximum heart rate) for 150 min/week
|
40-55% maximum heart rate for 150min/week
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in carotid vessel wall volume measured by magnetic resonance imaging (MRI)
Time Frame: Baseline, 1 year, 2 years
|
Baseline, 1 year, 2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in waist circumference
Time Frame: Baseline, 1 year, 2 years
|
Baseline, 1 year, 2 years
|
Change in hip circumference
Time Frame: Baseline, 1 year, 2 years
|
Baseline, 1 year, 2 years
|
Change in BMI
Time Frame: Baseline, 1 year, 2 years
|
Baseline, 1 year, 2 years
|
Change in abdominal visceral adipose tissue
Time Frame: Baseline, 1 year, 2 years
|
Baseline, 1 year, 2 years
|
Change in abdominal subcutaneous adipose tissue
Time Frame: Baseline, 1 year, 2 years
|
Baseline, 1 year, 2 years
|
Change in thoracic visceral adipose tissue
Time Frame: Baseline, 1 year, 2 years
|
Baseline, 1 year, 2 years
|
Change in hepatic fat fraction
Time Frame: Baseline, 1 year, 2 years
|
Baseline, 1 year, 2 years
|
Change in blood pressure
Time Frame: Baseline, 1 year, 2 years
|
Baseline, 1 year, 2 years
|
Change in standard plasma lipid fractions
Time Frame: Baseline, 1 year, 2 years
|
Baseline, 1 year, 2 years
|
Change in plasma apolipoprotein A1
Time Frame: Baseline, 1 year, 2 years
|
Baseline, 1 year, 2 years
|
Change in plasma apolipoprotein B
Time Frame: Baseline, 1 year, 2 years
|
Baseline, 1 year, 2 years
|
Change in plasma lipid particle size
Time Frame: Baseline, 1 year, 2 years
|
Baseline, 1 year, 2 years
|
Change in blood glucose
Time Frame: Baseline, 1 year, 2 years
|
Baseline, 1 year, 2 years
|
Change in blood insulin
Time Frame: Baseline, 1 year, 2 years
|
Baseline, 1 year, 2 years
|
Change in blood HbA1c
Time Frame: Baseline, 1 year, 2 years
|
Baseline, 1 year, 2 years
|
Change in adiponectin
Time Frame: Baseline, 1 year, 2 years
|
Baseline, 1 year, 2 years
|
Change in IL-6
Time Frame: Baseline, 1 year, 2 years
|
Baseline, 1 year, 2 years
|
Change in TNF-alpha
Time Frame: Baseline, 1 year, 2 years
|
Baseline, 1 year, 2 years
|
Change in CRP
Time Frame: Baseline, 1 year, 2 years
|
Baseline, 1 year, 2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Eric Larose, DVM, MD, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIHR MOP-137079
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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