Resistance Exercise for Cardiovascular Risk

(DoReps Trial)

Overseen By Duck-chul Lee, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Heart disease, Cancer, Autoimmune, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 12 months

240 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to consult with the trial coordinators or your doctor for guidance.

What data supports the effectiveness of the treatment Resistance Exercise for reducing cardiovascular risk?

Research shows that resistance exercise can improve cardiovascular health by enhancing muscle strength and endurance, and positively influencing cardiovascular risk factors, metabolism, and quality of life. It is particularly beneficial for patients with coronary heart disease and can be safely included in cardiac rehabilitation programs for those with good cardiac performance capacity. ^{1 2 3 4 5}

Is resistance exercise generally safe for humans?

Resistance exercise is generally considered safe for humans, including those with cardiovascular conditions, as it can improve muscle strength and cardiovascular health without reported risks in studies. However, caution is advised for individuals with specific heart conditions due to potential blood pressure responses. ^{2 6 7 8 9}

How does resistance exercise differ from other treatments for cardiovascular risk?

Resistance exercise, unlike many traditional cardiovascular treatments, focuses on building muscle strength and endurance, which can improve heart health and reduce risk factors. It is unique because it can be combined with aerobic exercise for enhanced benefits and is tailored to individual capabilities, making it a versatile option for improving cardiovascular health. ^{1 5 7 8 10}

What is the purpose of 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.

Research Team

Duck-chul Lee, PhD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for individuals at risk of cardiovascular disease who are interested in understanding how different amounts of resistance exercise can impact their heart health. There's no specific duration mentioned, but participants should be willing to engage in either aerobic or resistance exercises as per the study requirements.

Inclusion Criteria

Inactive: not meeting the US resistance and aerobic exercise guidelines over the last 6 months

Non-Smoker

Overweight or Obese: Body Mass Index 25-43 kg/m2

Exclusion Criteria

I have a serious health condition that could worsen with exercise.

My heart condition is stable.

Pregnancy/anticipated pregnancy during the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to varying dosages of resistance exercise for 1 year, with baseline, 6-month, and 12-month physical examinations

12 months

Baseline, 6-month, and 12-month visits

Supervised Exercise

First 6 months of intervention in a supervised lab-based setting, assessing changes in CVD risk factors

6 months

Unsupervised Exercise

Second 6 months in a free-living environment with a health club membership, focusing on adherence

6 months

Follow-up

Participants are monitored for long-term effects and adherence to exercise regimen

4 weeks

Treatment Details

Interventions

• Resistance Exercise

Trial Overview The study is testing four different exercise regimens: 30 minutes, 60 minutes, and 120 minutes of resistance training, compared with aerobic exercise only. The goal is to determine how each amount affects cardiovascular health and establish guidelines for effective exercise doses.

Participant Groups

Group I: Aerobic Exercise (AE) only Experimental Treatment 1 Intervention

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.

Group II: 60 min of resistance exercise (RE) Experimental Treatment 1 Intervention

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.

Group III: 30 min of resistance exercise (RE) Experimental Treatment 1 Intervention

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.

Group IV: 120 min of resistance exercise (RE) Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Harvard School of Public Health (HSPH)

Collaborator

Trials

283

Recruited

17,030,000+

Iowa State University

Collaborator

Trials

63

Recruited

145,000+

University of California, Riverside

Collaborator

Trials

33

Recruited

14,400+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Findings from Research

Resistance training has been shown to significantly improve survival rates in patients with coronary heart disease, highlighting its importance in secondary prevention of cardiovascular disease.

The review outlines safe practices and specific guidelines for prescribing resistance exercise to cardiac patients, ensuring that the benefits can be maximized while minimizing risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resistance exercise in cardiac rehabilitation. Wise, FM., Patrick, JM.[2011]

Resistance exercise (RE) can significantly reduce the risk of cardiovascular disease (CVD) events and all-cause mortality, with even just one session per week or less than an hour of exercise showing a 40%-70% decrease in risk compared to no RE.

The benefits of RE on CVD risk are mediated by reductions in body mass index (BMI), indicating that maintaining a healthy weight may enhance the protective effects of resistance exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations of Resistance Exercise with Cardiovascular Disease Morbidity and Mortality. Liu, Y., Lee, DC., Li, Y., et al.[2020]

Elderly patients with cardiovascular disease can benefit from cardiac rehabilitation programs just as much as younger patients, despite concerns about their fragility and health risks.

Incorporating resistance exercise training into cardiac rehabilitation is essential for maximizing functional improvements in older patients, highlighting the need for tailored exercise prescriptions to ensure safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resistance Exercise in the Elderly Person with Cardiovascular Disease. Braith, RW., Vincent, KR.[2019]

Resistance exercise (RE) is recommended in cardiac rehabilitation (CR) due to the high prevalence of lean mass abnormalities like dynapenia and sarcopenia in patients with cardiovascular disease (CVD).

Current evidence suggests that RE can improve exercise capacity, muscle strength, body composition, cardiovascular health, and quality of life in CR patients, highlighting the need for personalized exercise prescriptions tailored to individual health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resistance exercise for cardiac rehabilitation. Kirkman, DL., Lee, DC., Carbone, S.[2023]

Dynamic resistance training can be safely included in cardiac rehabilitation for selected patients, as it does not pose a higher risk than aerobic training when properly supervised and tailored to individual needs.

Low-intensity resistance training (40-60% of maximum voluntary contraction) with controlled repetitions leads to only modest increases in blood pressure, similar to moderate endurance training, making it a viable option for improving muscle strength and cardiovascular health in patients with good cardiac function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recommendations for resistance exercise in cardiac rehabilitation. Recommendations of the German Federation for Cardiovascular Prevention and Rehabilitation. Bjarnason-Wehrens, B., Mayer-Berger, W., Meister, ER., et al.[2019]

A study involving 36 participants (12 healthy volunteers, 12 with stable coronary artery disease, and 12 with stable congestive heart failure) found that left ventricular function remained stable during moderate-intensity resistance exercises, such as leg presses and shoulder presses.

Despite increases in blood pressure during resistance training, there was no significant deterioration in heart function, indicating that resistance training can be safely included in cardiac rehabilitation programs for patients with congestive heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hemodynamic responses during aerobic and resistance exercise. Karlsdottir, AE., Foster, C., Porcari, JP., et al.[2019]

Regular weight-training can lead to positive adaptations in cardiovascular health, including decreased heart rate during maximal work and improved myocardial structure, which may help reduce the risk of cardiovascular disease.

Resistance training can also enhance aerobic capacity and improve metabolic health markers like glucose tolerance and insulin sensitivity, although caution is advised for individuals with existing cardiovascular conditions due to potential blood pressure responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health- and performance-related potential of resistance training. Stone, MH., Fleck, SJ., Triplett, NT., et al.[2022]

Resistance training is a safe and effective method for improving cardiovascular health in both healthy adults and those with cardiovascular disease, as highlighted in this updated American Heart Association statement.

The statement emphasizes the importance of incorporating resistance training, alongside aerobic exercises, to enhance cardiovascular health and provides practical strategies to encourage more adults to engage in this type of exercise, as less than one-third currently meet the recommended guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resistance Exercise Training in Individuals With and Without Cardiovascular Disease: 2023 Update: A Scientific Statement From the American Heart Association. Paluch, AE., Boyer, WR., Franklin, BA., et al.[2023]

Resistance exercises are safe and effective for patients with coronary artery disease (CAD), post-myocardial infarction (MI), and those who have undergone coronary artery bypass grafting (CABG), as shown in a review of 11 studies from 1997 to 2007.

The benefits of resistance training include improved muscular strength, increased physical capacity, and enhanced emotional well-being and quality of life, with no reported risks associated with the exercises.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resistance exercises for health promotion in coronary patients: evidence of benefits and risks. Oliveira, JL., Galvão, CM., Rocha, SM.[2011]

A 6-week resistance training program in 30 young healthy males showed that both moderate and high-intensity exercises significantly reduced levels of LDL cholesterol and improved the cholesterol/HDL ratio compared to a control group.

High-intensity resistance training was particularly effective, leading to a decrease in plasma fibrinogen and an increase in HDL levels, indicating better cardiovascular health outcomes compared to moderate intensity training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in cardiovascular risk factors and inflammatory markers of young, healthy, men after six weeks of moderate or high intensity resistance training. Sheikholeslami Vatani, D., Ahmadi, S., Ahmadi Dehrashid, K., et al.[2017]

References

1. England pubmed.ncbi.nlm.nih.gov

Resistance exercise in cardiac rehabilitation. [2011]

2. United States pubmed.ncbi.nlm.nih.gov

Associations of Resistance Exercise with Cardiovascular Disease Morbidity and Mortality. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Resistance Exercise in the Elderly Person with Cardiovascular Disease. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Resistance exercise for cardiac rehabilitation. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Recommendations for resistance exercise in cardiac rehabilitation. Recommendations of the German Federation for Cardiovascular Prevention and Rehabilitation. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Hemodynamic responses during aerobic and resistance exercise. [2019]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Health- and performance-related potential of resistance training. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Resistance Exercise Training in Individuals With and Without Cardiovascular Disease: 2023 Update: A Scientific Statement From the American Heart Association. [2023]

9. Australia pubmed.ncbi.nlm.nih.gov

Resistance exercises for health promotion in coronary patients: evidence of benefits and risks. [2011]

10. Italy pubmed.ncbi.nlm.nih.gov

Changes in cardiovascular risk factors and inflammatory markers of young, healthy, men after six weeks of moderate or high intensity resistance training. [2017]