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NCT Number: NCT06619444

Dose-Response to Resistance Exercise on Cardiovascular Health

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.

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Key information

Conditions

Cardiovascular Risk Behavior Motor Activity

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physical Activity Research Center (PARC)

Pittsburgh, Pennsylvania, 15219, United States

Location status: Recruiting

Location contact

Duck-chul Lee, PhD

CONTACT

[email protected]

412-383-4004

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Aerobic exercise only

Behavioral

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

Other names: Aerobic Exercise

30 min of resistance exercise

Behavioral

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.

Other names: resistance training

60 min of resistance exercise

Behavioral

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.

Other names: resistance training

120 min of resistance exercise

Behavioral

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.

Other names: resistance training

Primary outcomes

  1. Change from baseline in composite cardiovascular risk score at 6 months

    Time frame: Baseline and 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.

Secondary outcomes

  1. Change from baseline in arterial stiffness at 6 months

    Time frame: Baseline and 6 months

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

  2. Change from baseline in inflammatory markers at 6 months

    Time frame: Baseline and 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).

Other outcomes

  1. Adherence to resistance exercise associated with dose prescription at 12 months

    Time frame: 6 months and 12 months

    This secondary outcome seeks to assess the resistance exercise dose associated with the best adherence to the resistance exercise training prescription during the self-maintenance period of months 6 to 12.

Study contacts

Contact information is provided by the study sponsor or research team.

Duck-chul Lee, PhD

CONTACT

[email protected]

412-383-4004

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Harvard School of Public Health (HSPH)
  • Iowa State University
  • National Heart, Lung, and Blood Institute (NHLBI)
  • University of California, Riverside

Registry information

Acronym: DoReps

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 1, 2024
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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