AtherosclerosisMoMANCT02628275
Impact of Mild or Moderate Physical Activity and Progression of Subclinical Atherosclerosis
A study testing Moderate to vigorous physical activity and Light physical activity in people with Atherosclerosis, run by Laval University at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- Moderate to vigorous physical activity and Light physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2015to Oct 2022
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
Québec, G1V 4G5
About this study
Official title: 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.
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.
- Conditions
- Atherosclerosis
- Being tested
- Moderate to vigorous physical activity, Light physical activity
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate to vigorous physical activityBehavioural
55-90% maximum heart rate for 150min/week (current recommendations)
Light physical activityBehavioural
40-55% maximum heart rate for 150min/week
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Continued inactivity |
| Moderate to vigorous physical activity | Active comparator | MVPA (55-90% of maximum heart rate) for 150 min/week (current recommendations) Receives: Behavioral: Moderate to vigorous physical activity |
| Light physical activity | Active comparator | LPA (40-55% of maximum heart rate) for 150 min/week Receives: Behavioral: Light physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in carotid vessel wall volume measured by magnetic resonance imaging (MRI)
Measured: Baseline, 1 year, 2 years
Secondary outcomes (19)
Change in waist circumference
Measured: Baseline, 1 year, 2 years
Change in hip circumference
Measured: Baseline, 1 year, 2 years
Change in BMI
Measured: Baseline, 1 year, 2 years
Change in abdominal visceral adipose tissue
Measured: Baseline, 1 year, 2 years
Change in abdominal subcutaneous adipose tissue
Measured: Baseline, 1 year, 2 years
Change in thoracic visceral adipose tissue
Measured: Baseline, 1 year, 2 years
Change in hepatic fat fraction
Measured: Baseline, 1 year, 2 years
Change in blood pressure
Measured: Baseline, 1 year, 2 years
Change in standard plasma lipid fractions
Measured: Baseline, 1 year, 2 years
Change in plasma apolipoprotein A1
Measured: Baseline, 1 year, 2 years
Change in plasma apolipoprotein B
Measured: Baseline, 1 year, 2 years
Change in plasma lipid particle size
Measured: Baseline, 1 year, 2 years
Change in blood glucose
Measured: Baseline, 1 year, 2 years
Change in blood insulin
Measured: Baseline, 1 year, 2 years
Change in blood HbA1c
Measured: Baseline, 1 year, 2 years
Change in adiponectin
Measured: Baseline, 1 year, 2 years
Change in IL-6
Measured: Baseline, 1 year, 2 years
Change in TNF-alpha
Measured: Baseline, 1 year, 2 years
Change in CRP
Measured: Baseline, 1 year, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study startAug 2015
- Primary completionOct 2022
- Study completionOct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Eric Larose, DVM, MD, FRCPC, FCCS, FAHA, Laval University
- Investigators
- Eric Larose, DVM, MD, Principal investigator, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02628275
- Sponsor's protocol ID
- CIHR MOP-137079
- Acronym
- MoMA
- Status last verified
- Oct 2023
- First submitted
- 26 Nov 2015
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Will Mild vs. Moderate Physical Activity Suffice to Abate the Progression of Subclinical Atherosclerosis in Sedentary Adults?
- ClinicalTrials.gov ID
- NCT02628275
- Acronym / sponsor ID
- MoMA / CIHR MOP-137079
- Conditions
- Atherosclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Aug 2015 (actual)
- Primary completion
- Oct 2022 (actual)
- Study completion
- Oct 2022 (actual)
- First posted
- 11 Dec 2015 (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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Continued inactivity |
| Moderate to vigorous physical activity | Active comparator | Behavioral: Moderate to vigorous physical activityMVPA (55-90% of maximum heart rate) for 150 min/week (current recommendations) |
| Light physical activity | Active comparator | Behavioral: Light physical activityLPA (40-55% of maximum heart rate) for 150 min/week |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
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 |
|---|---|---|
| Moderate to vigorous physical activity55-90% maximum heart rate for 150min/week (current recommendations) | Behavioural | Moderate to vigorous physical activity |
| Light physical activity40-55% maximum heart rate for 150min/week | Behavioural | Light physical activity |
Primary outcome
Change in carotid vessel wall volume measured by magnetic resonance imaging (MRI)
Time frame: Baseline, 1 year, 2 years
19 secondary outcomes
Change in waist circumference
Time frame: Baseline, 1 year, 2 years
Change in hip circumference
Time frame: Baseline, 1 year, 2 years
Change in BMI
Time frame: Baseline, 1 year, 2 years
Change in abdominal visceral adipose tissue
Time frame: Baseline, 1 year, 2 years
Change in abdominal subcutaneous adipose tissue
Time frame: Baseline, 1 year, 2 years
Change in thoracic visceral adipose tissue
Time frame: Baseline, 1 year, 2 years
Change in hepatic fat fraction
Time frame: Baseline, 1 year, 2 years
Change in blood pressure
Time frame: Baseline, 1 year, 2 years
Change in standard plasma lipid fractions
Time frame: Baseline, 1 year, 2 years
Change in plasma apolipoprotein A1
Time frame: Baseline, 1 year, 2 years
Change in plasma apolipoprotein B
Time frame: Baseline, 1 year, 2 years
Change in plasma lipid particle size
Time frame: Baseline, 1 year, 2 years
Change in blood glucose
Time frame: Baseline, 1 year, 2 years
Change in blood insulin
Time frame: Baseline, 1 year, 2 years
Change in blood HbA1c
Time frame: Baseline, 1 year, 2 years
Change in adiponectin
Time frame: Baseline, 1 year, 2 years
Change in IL-6
Time frame: Baseline, 1 year, 2 years
Change in TNF-alpha
Time frame: Baseline, 1 year, 2 years
Change in CRP
Time frame: Baseline, 1 year, 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
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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.
Eric Larose, DVM, MD principal investigator
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate to vigorous physical activity and Light physical activity in people with Atherosclerosis, run by Laval University 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 7 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: finished, as of the sponsor's last update on 4 Oct 2023. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 in carotid vessel wall volume measured by magnetic resonance imaging (MRI) (time frame: Baseline, 1 year, 2 years). 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 4 Oct 2023.