Impact of Mild or Moderate Physical Activity and Progression of Subclinical Atherosclerosis (MoMA)

October 2, 2023 updated by: Eric Larose, DVM, MD, FRCPC, FCCS, FAHA, Laval University

Will Mild vs. Moderate Physical Activity Suffice to Abate the Progression of Subclinical Atherosclerosis in Sedentary Adults?

Subclinical atherosclerosis is identified in roughly 2/3rd of otherwise healthy young adults. How much physical activity is required to prevent progression of subclinical atherosclerosis? In the 85% of healthy younger Canadian men and women who do NOT perform the recommended 150 min/week of moderate- to vigorous-intensity physical activity (MVPA) as recommended, is it reasonable to aim for a lower regimen of light physical activity (LPA) despite the absence of supporting literature, or to the contrary should the investigators insist on achieving MVPA? In this perspective, MoMA provides a unique opportunity to determine whether LPA vs. MVPA is necessary to limit subclinical atherosclerosis progression in inactive otherwise healthy adults. Resolving such unknowns should inform strategies to prevent decades of silent disease progression leading to future morbidity and mortality.

Study Overview

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

Interventional

Enrollment (Actual)

129

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Québec, Canada, G1V 4G5
        • Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Eric Larose, DVM, MD, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2015

Primary Completion (Actual)

October 1, 2022

Study Completion (Actual)

October 1, 2022

Study Registration Dates

First Submitted

November 26, 2015

First Submitted That Met QC Criteria

December 8, 2015

First Posted (Estimated)

December 11, 2015

Study Record Updates

Last Update Posted (Actual)

October 4, 2023

Last Update Submitted That Met QC Criteria

October 2, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

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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