Dose-Response to Resistance Exercise on Cardiovascular Health
DoReps
2 other identifiers
interventional
240
1 country
1
Brief Summary
A large body of evidence indicates numerous health benefits of physical activity, including prevention of cardiovascular disease (CVD), the leading cause of death in the US. This evidence has led to US Physical Activity Guidelines that recommend ≥150 min/week of moderate or ≥75 min/week of vigorous aerobic exercise (AE), plus resistance exercise (RE; such as weight lifting) on ≥2 days/week. To date, current research has mostly focused on AE, and we know a great deal about the dose-response relation between AE and health, resulting in clear and practical guidance to the public on the recommended "dose" in min/week. However, currently far less is known about the dose-response for RE: ≥2 days/week are recommended, but with no duration specified. Thus, this project aims to provide clarity on the dose relationship between RE and health. This project will significantly contribute to developing more effective CVD prevention approaches, advancing prescriptive intervention guidelines, by helping to fill the important gaps in knowledge on effective minimum dose, beneficial optimal dose, and safe maximum dose of RE for CVD prevention. Thus, advancing prescriptive intervention guidelines, and provide important insights for future science of physical activity and health.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2024
CompletedFirst Posted
Study publicly available on registry
October 1, 2024
CompletedStudy Start
First participant enrolled
December 3, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
August 12, 2025
August 1, 2025
2.5 years
September 26, 2024
August 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in composite cardiovascular risk score at 6 months
The primary outcome will be change from baseline to 6 months in the average composite cardiovascular disease (CVD) risk z-score comprising systolic Blood pressure (SBP), Low-Density lipoprotein cholesterol (LDL-C), fasting glucose, and percent body fat; lower scores indicate better overall CVD risk profile. Each CVD risk factor at baseline and 6 months will be individually standardized to sex-specific z -scores with a mean of 0 and standard deviation (SD) of 1 based on the formula (observed value-mean)/SD for each participant, using the baseline means and SDs from the entire sample.
Baseline and 6 months
Secondary Outcomes (2)
Change from baseline in arterial stiffness at 6 months
Baseline and 6 months
Change from baseline in inflammatory markers at 6 months
Baseline and 6 months
Other Outcomes (1)
Adherence to resistance exercise associated with dose prescription at 12 months
6 months and 12 months
Study Arms (4)
Aerobic Exercise (AE) only
EXPERIMENTALAerobic exercise (AE) training will consist of 60 min of treadmill, elliptical, or bike exercise at a moderate to vigorous (50-80% of heart rate reserve). Intensity of the exercise sessions will be built of gradually. Sessions will occur 2 times per week for the duration of the year.
30 min of resistance exercise (RE)
EXPERIMENTAL30 min of resistance exercise (RE) will consist of 30 total minutes of resistance exercise each week (15 min each session) in addition to 60 min of aerobic exercise (AE) each week (30 min each session). Each 15 min session of RE will consist of 2 sets of 8-15 repetitions at 50-80% of 1-rep max of 4 exercises. AE will consist of treadmill, elliptical, or bike exercise at moderate to vigorous intensity (50-80% of heart rate reserve). Intensity of the exercise sessions will be increased gradually. With 1 min rest between sets, this plan is estimated to take approximately 45 min per session. Sessions will occur 2 times per week for the duration of 1 year.
60 min of resistance exercise (RE)
EXPERIMENTAL60 min of resistance exercise (RE) will consist of 60 total minutes of resistance exercise each week (30 min each session) in addition to 60 min of aerobic exercise each week (30 min each session). Each 30 min session of resistance exercise will consist of 2 sets of 8-15 repetitions at 50-80% of 1-rep max of 8 exercises. Aerobic exercise will consist of treadmill, elliptical, or bike exercise at moderate to vigorous intensity (50-80% of heart rate reserve). Intensity of the exercise sessions will be increased gradually. With 1 min rest between sets, this plan is estimated to take approximately 60 min per session. Sessions will occur 2 times per week for the duration of 1 year.
120 min of resistance exercise (RE)
EXPERIMENTAL120 min of resistance exercise (RE) will consist of 120 total minutes of resistance exercise each week (60 min each session) in addition to 60 min of aerobic exercise each week (30 min each session). Each 60 min session of resistance exercise will consist of 3 sets of 8-15 repetitions at 50-80% of 1-rep max of 10 exercises. Aerobic exercise will consist of treadmill, elliptical, or bike exercise at moderate to vigorous intensity (50-80% of heart rate reserve). Intensity of the exercise sessions will be increased gradually. With 1 min rest between sets, this plan is estimated to take approximately 90 min per session. Sessions will occur 2 times per week for the duration of 1 year.
Interventions
Aerobic exercise training will consist of 60 min of treadmill, elliptical, or bike exercise at a moderate to vigorous (50-80% of heart rate reserve). Intensity of the exercise sessions will be built of gradually. Sessions will occur 2 times per week for the duration of the year trial
30 min of resistance exercise (RE) will consist of 30 total minutes of resistance exercise each week (15 min each session) in addition to 60 min of aerobic exercise each week (30 min each session). Each 15 min session of resistance exercise will consist of 2 sets of 8-15 repetitions at 50-80% of 1-rep max of 4 exercises. Aerobic exercise will consist of treadmill, elliptical, or bike exercise at moderate to vigorous intensity (50-80% of heart rate reserve). Intensity of the exercise sessions will be increased gradually. With 1 min rest between sets, this plan is estimated to take approximately 45 min per session. Sessions will occur 2 times per week for the duration of 1 year.
60 min of resistance exercise (RE) will consist of 60 total minutes of resistance exercise each week (30 min each session) in addition to 60 min of aerobic exercise each week (30 min each session). Each 30 min session of resistance exercise will consist of 2 sets of 8-15 repetitions at 50-80% of 1-rep max of 8 exercises. Aerobic exercise will consist of treadmill, elliptical, or bike exercise at moderate to vigorous intensity (50-80% of heart rate reserve). Intensity of the exercise sessions will be increased gradually. With 1 min rest between sets, this plan is estimated to take approximately 60 min per session. Sessions will occur 2 times per week for the duration of 1 year.
120 min of resistance exercise (RE) will consist of 120 total minutes of resistance exercise each week (60 min each session) in addition to 60 min of aerobic exercise each week (30 min each session). Each 60 min session of resistance exercise will consist of 3 sets of 8-15 repetitions at 50-80% of 1-rep max of 10 exercises. Aerobic exercise will consist of treadmill, elliptical, or bike exercise at moderate to vigorous intensity (50-80% of heart rate reserve). Intensity of the exercise sessions will be increased gradually. With 1 min rest between sets, this plan is estimated to take approximately 90 min per session. Sessions will occur 2 times per week for the duration of 1 year.
Eligibility Criteria
You may qualify if:
- Non-Smoker
- Overweight or Obese: Body Mass Index 25-43 kg/m2
- Inactive: not meeting the US resistance and aerobic exercise guidelines over the last 6 months
- Walking \<7,000 steps/day at baseline
- Capable of performing the required exercise training
You may not qualify if:
- Absolute
- Unstable coronary heart disease or heart failure
- Uncontrolled arrhythmias or severe aortic stenosis
- Acute myocarditis, endocarditis, or pericarditis
- Cancer, requiring treatment in the past 5 years
- Autoimmune diseases, affecting immune system
- Plans to be away ≥4 weeks in the next 1 year
- Pregnancy/anticipated pregnancy during the study
- Other medical condition that is life-threatening or can interfere with or be aggravated by the exercise training
- Uncontrolled Diabetes (HbA1c ≥8.0),
- Hypertensive Blood Pressure ≥160 mm Hg Systolic and/or 100 mm Hg Diastolic,
- Relative (should consult a physician)
- Major risk factors for coronary heart disease
- Uncontrolled diabetes or musculoskeletal limitations
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pittsburghlead
- University of California, Riversidecollaborator
- Iowa State Universitycollaborator
- Harvard School of Public Health (HSPH)collaborator
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
Study Sites (1)
Physical Activity Research Center (PARC)
Pittsburgh, Pennsylvania, 15219, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Duck-chul Lee, PhD
University of Pittsburgh
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Physical Activity Research Center
Study Record Dates
First Submitted
September 26, 2024
First Posted
October 1, 2024
Study Start
December 3, 2024
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
August 12, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- ICF
Datasets will be available to outside researchers and public health professionals through the web sites of the ClinicalTrials.gov and The Physical Activity Research Center (PARC) at the University of Pittsburgh. Outside researchers can learn what data are available and request a de-identified dataset (stripped of all personal health identifiers). All outside investigators must pass an NIH-approved equivalent course on the Protection of Human Subjects. All data requests will be discussed with the research team and approval will be obtained from the institutional review board overseeing the proposal of the data analysis project. Findings from the proposed study will also be disseminated at national and international meetings and publish the findings in peer-reviewed journals. The investigators seek to maximize the knowledge discovered from this study by sharing data to expedite the translation of research into practice to improve cardiovascular health.