Recruiting

Resistance Exercise

Sponsor:

University of Pittsburgh

Code:

NCT06619444

Conditions

Cardiovascular Risk

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Aerobic exercise only

30 min of resistance exercise

60 min of resistance exercise

120 min of resistance exercise

Study Details

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.

Conditions

Cardiovascular Risk

Study ID

NCT06619444

Start date

Dec 3, 2024

Status verified date

Jul, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Aerobic Exercise (AE) only

Aerobic 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.

experimental: 30 min of resistance exercise (RE)

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 (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.

experimental: 60 min of resistance exercise (RE)

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.

experimental: 120 min of resistance exercise (RE)

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.

Interventions

Aerobic exercise only

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

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

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

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.

Primary outcome measure

  • Change from baseline in composite cardiovascular risk score at 6 months [ Time Frame: Baseline and 6 months ]

Central Contacts and Locations

Central contacts

Duck-chul Lee, PhD

412-383-4004dclee@pitt.edu

Locations

Physical Activity Research Center (PARC)

Recruiting

Pittsburgh, Pennsylvania, United States, 15219

Contacts

Duck-chul Lee, PhD

412-383-4004dclee@pitt.edu

More Information

Sponsor

University of Pittsburgh

Last update posted

Jul 7, 2026

Last verified

Jul, 2026

Keywords

  • Exercise

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-07-07.