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Cardiovascular RiskDoRepsNCT06619444

Dose-Response to Resistance Exercise on Cardiovascular Health

A study testing Aerobic exercise only, 30 min of resistance exercise and 60 min of resistance exercise in people with Cardiovascular Risk, run by University of Pittsburgh at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Cardiovascular Risk
What is being tested?
Aerobic exercise only, 30 min of resistance exercise and 60 min of resistance exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
1 siteUnited States
Study dates
3 Dec 2024to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Duck-chul Lee, PhD contact

412-383-4004

dclee@pitt.edu

United States1 site, 1 recruiting
  • Physical Activity Research Center (PARC)

    Pittsburgh, Pennsylvania, 15219

    Duck-chul Lee, PhD, 412-383-4004, dclee@pitt.edu

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

Participants will be randomly assigned to 1 of four research conditions at varying dosage of resistance exercise (RE) for the duration of 1 year, either 0 min, 30 min, 60 min or 120 min of weekly RE in addition to 60 min of weekly aerobic exercise (AE). Total exercise duration will be split between 2 weekly sessions. Participants in all four groups will receive healthy lifestyle education sessions, and will track daily steps, food intake and activity levels throughout the 1-year intervention. Participants will also complete baseline, 6-month, and 12-month physical examinations, which will include assessments of blood pressure, blood lipids, body composition, and aerobic and muscular fitness. During the first 6 months of intervention will occur in a supervised lab-based setting. Changes in Cardiovascular disease (CVD) risk factors, as well as potential mechanisms (arterial stiffness and inflammatory markers) that might explain a J-shaped dose-response, from baseline to 6 months will be assessed in each of the 4 groups. The second 6 months will follow the same exercise intervention as the first 6 months. However, all participants will be provided with a free health club membership. The second 6 months will be used to investigate the RE dose associated with best adherence in a free-living environment during the second 6 months. In addition, all measures taken at 6 months will also be assessed again at 12 months to examine the long-term effects of different doses of RE as secondary outcomes, given that compliance will not be tightly "enforced" by staff in this unsupervised free-living condition. In this case, the investigators will further carefully consider exercise adherence in data analysis.

Being tested
Aerobic exercise only, 30 min of resistance exercise, 60 min of resistance exercise, 120 min of resistance exercise
Keywords
Exercise
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aerobic exercise onlyBehavioural

    Also called Aerobic Exercise

    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 exerciseBehavioural

    Also called resistance training

    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 exerciseBehavioural

    Also called resistance training

    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 exerciseBehavioural

    Also called resistance training

    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.

Study groups in NCT06619444
Study groupRoleWhat they receive
Aerobic Exercise (AE) onlyExperimentalAerobic 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.
Receives: Behavioral: Aerobic exercise only
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.
Receives: Behavioral: 30 min of resistance exercise
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.
Receives: Behavioral: 60 min of resistance exercise
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.
Receives: Behavioral: 120 min of resistance exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and 6 months

Secondary outcomes (2)
  1. Change from baseline in arterial stiffness at 6 months

    Primary outcome will assess changes in all 4 groups from baseline to 6 months on aortic arterial stiffness (purse wave velocity).

    Measured: Baseline and 6 months

  2. Change from baseline in inflammatory markers at 6 months

    Outcome will assess changes in all 4 groups from baseline to 6 months inflammatory markers (e.g., C-reactive protein, Interleukin 6, Tumor Necrosis Factor alpha).

    Measured: Baseline and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2024
  2. Study start3 Dec 2024
  3. Primary completionJun 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06619444
Sponsor's protocol ID
STUDY24070155
Other IDs
R01HL171098
Acronym
DoReps
Status last verified
Jul 2026
First submitted
26 Sep 2024
Last updated
7 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Aerobic exercise only, 30 min of resistance exercise and 60 min of resistance exercise in people with Cardiovascular Risk, run by University of Pittsburgh at 1 site in United States.

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 5 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 7 Jul 2026. 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 United States. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Duck-chul Lee, PhD (412-383-4004, dclee@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in composite cardiovascular risk score at 6 months (time frame: Baseline and 6 months). 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 7 Jul 2026.

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