Dose-Response to Resistance Exercise on Cardiovascular Health
ConditionCardiovascular Risk
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorUniversity of Pittsburgh
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Aerobic exercise only
BehavioralAerobic 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
Behavioral30 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
Behavioral60 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
Behavioral120 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.
Treatment groups
240 Participants
are divided into 4 treatment groupsGroup A: Aerobic Exercise (AE) onlyExperimental treatment 1 intervention
Group B: 30 min of resistance exercise (RE)Experimental treatment 1 intervention
Group C: 60 min of resistance exercise (RE)Experimental treatment 1 intervention
Group D: 120 min of resistance exercise (RE)Experimental treatment 1 intervention
Trial outcomes
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.
Time frame
Baseline and 6 monthsSecondary outcomes
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).
Time frame
Baseline and 6 months2
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).
Time frame
Baseline and 6 monthsOther outcomes
1
Adherence to resistance exercise associated with dose prescription at 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.
Time frame
6 months and 12 monthsSponsors and contacts
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University of Pittsburgh
Lead sponsor
University of California, Riverside
Collaborator
Iowa State University
Collaborator
Harvard School of Public Health (HSPH)
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov