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

NCT02628275 | Completed

• 1 other identifier: CIHR MOP-137079
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atherosclerosis

Outcome Measures

Primary Outcomes (1)

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

  Baseline, 1 year, 2 years

Secondary Outcomes (19)

• Change in waist circumference

  Baseline, 1 year, 2 years

• Change in hip circumference

  Baseline, 1 year, 2 years

• Change in BMI

  Baseline, 1 year, 2 years

• Change in abdominal visceral adipose tissue

  Baseline, 1 year, 2 years

• Change in abdominal subcutaneous adipose tissue

  Baseline, 1 year, 2 years

Study Arms (3)

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)

Behavioral: Moderate to vigorous physical activity

Light physical activity

ACTIVE COMPARATOR

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

Behavioral: Light physical activity

Interventions

Moderate to vigorous physical activity BEHAVIORAL

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

Moderate to vigorous physical activity

Light physical activity BEHAVIORAL

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

Light physical activity

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laval University: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval

Québec, G1V 4G5, Canada

Location

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Eric Larose, DVM, MD

  Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor, Faculty of Medicine

Study Record Dates

• First Submitted: November 26, 2015
• First Posted: December 11, 2015
• Study Start: August 1, 2015
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: October 4, 2023

Record last verified: 2023-10

Locations

CA (1)