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CompletedNCT02628275MoMAUpdated Oct 4, 2023

Impact of Mild or Moderate Physical Activity and Progression of Subclinical Atherosclerosis

An interventional study of Moderate to vigorous physical activity and Light physical activity in Atherosclerosis, sponsored by Laval University. Completed at 1 site in Canada. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-04.

Sponsored by Laval University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Aug 2015, registered Nov 2015).
Phase
Not applicable
Study type
Interventional
Enrollment
129
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Atherosclerosis

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03

In context

Atherosclerosis

1,596 studies on the registry are indexed under Atherosclerosis; 262 are open to participants now.

This study's enrollment of 129 is above the median of 105 across 898 interventional studies indexed under Atherosclerosis.

Browse Atherosclerosis studies →

Lead sponsor

Laval University is the lead sponsor of 380 studies on the registry; 70 are open to participants now.

Browse Laval University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
129 participants (actual)

Study arms

  • 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)

    Behavioral: Moderate to vigorous physical activity

  • Active comparator
    Light physical activity

    LPA (40-55% of maximum heart rate) for 150 min/week

    Behavioral: Light physical activity

Interventions

  • BehavioralModerate to vigorous physical activity

    55-90% maximum heart rate for 150min/week (current recommendations)

  • BehavioralLight physical activity

    40-55% maximum heart rate for 150min/week

06

What researchers measure

Primary outcomes

  1. Change in carotid vessel wall volume measured by magnetic resonance imaging (MRI)

    Time frame: Baseline, 1 year, 2 years

Secondary outcomes

  1. Change in waist circumference

    Time frame: Baseline, 1 year, 2 years

  2. Change in hip circumference

    Time frame: Baseline, 1 year, 2 years

  3. Change in BMI

    Time frame: Baseline, 1 year, 2 years

  4. Change in abdominal visceral adipose tissue

    Time frame: Baseline, 1 year, 2 years

  5. Change in abdominal subcutaneous adipose tissue

    Time frame: Baseline, 1 year, 2 years

  6. Change in thoracic visceral adipose tissue

    Time frame: Baseline, 1 year, 2 years

  7. Change in hepatic fat fraction

    Time frame: Baseline, 1 year, 2 years

  8. Change in blood pressure

    Time frame: Baseline, 1 year, 2 years

  9. Change in standard plasma lipid fractions

    Time frame: Baseline, 1 year, 2 years

  10. Change in plasma apolipoprotein A1

    Time frame: Baseline, 1 year, 2 years

  11. Change in plasma apolipoprotein B

    Time frame: Baseline, 1 year, 2 years

  12. Change in plasma lipid particle size

    Time frame: Baseline, 1 year, 2 years

  13. Change in blood glucose

    Time frame: Baseline, 1 year, 2 years

  14. Change in blood insulin

    Time frame: Baseline, 1 year, 2 years

  15. Change in blood HbA1c

    Time frame: Baseline, 1 year, 2 years

  16. Change in adiponectin

    Time frame: Baseline, 1 year, 2 years

  17. Change in IL-6

    Time frame: Baseline, 1 year, 2 years

  18. Change in TNF-alpha

    Time frame: Baseline, 1 year, 2 years

  19. Change in CRP

    Time frame: Baseline, 1 year, 2 years

07

Study locations

1 site
  • Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
    Québec, G1V 4G5, Canada
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2015 to primary completion in Oct 2022, 86 months.

Of 187 non-industry interventional studies with no phase under Atherosclerosis, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 55. This study's 86 months is above that.

Counting every sponsor, half of 209 studies reached it within 27 months; a quarter within 16 and three quarters within 56.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 26, 2015
First posted
Dec 11, 2015
StartActual
Aug 2015
Primary completionActual
Oct 2022
CompletionActual
Oct 2022
Last update
Oct 4, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 4, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02628275
Lead sponsor
Laval University
Collaborators
Canadian Institutes of Health Research (CIHR)
Responsible party
Eric Larose, DVM, MD, FRCPC, FCCS, FAHA (Full Professor, Faculty of Medicine, Laval University) — Principal investigator
First posted
Dec 11, 2015
Start date
Aug 2015
Primary completion
Oct 2022
Completion
Oct 2022
Last update
Oct 4, 2023

Study contacts

Eric Larose, DVM, MD
principal investigator · Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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