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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how varying amounts of resistance exercise, such as weight lifting, can help prevent heart disease. It will compare three groups engaging in different exercise amounts to identify the most effective regimen. The goal is to provide better guidance on the necessary amount of resistance exercise for maintaining heart health. Individuals who are overweight or obese, do not smoke, and have not been exercising regularly may be suitable candidates for this trial. Participants must be able to perform the exercise routines planned for the study. As an unphased trial, this study offers participants the chance to contribute to significant research that could enhance heart health recommendations for everyone.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that resistance exercise, such as weight lifting, is generally safe and beneficial for heart health. Studies have found that it can lower the risk of heart disease, reduce blood pressure, and aid in weight management. Adults, whether or not they have heart disease, usually tolerate resistance exercise well.

The available data report no major safety concerns, indicating that resistance exercise is safe for most people when performed correctly. To avoid injury, start slowly and gradually increase intensity. Those with specific health conditions should consult a doctor before beginning any new exercise routine. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different types of exercise can impact cardiovascular risk, a key factor in heart health. Unlike traditional treatments that rely on medication to manage cardiovascular risk, this study looks at varying amounts of resistance exercise combined with aerobic workouts to see how they can improve heart health. The trial compares different doses of resistance exercise, from 30 to 120 minutes per week, coupled with aerobic activities, and contrasts them with aerobic exercise alone. This approach is unique because it examines the potential benefits of integrating resistance exercises, which are often overlooked, into heart health strategies. Researchers hope to find out whether resistance training can provide an effective, non-medication-based option for reducing cardiovascular risk.

What evidence suggests that this trial's treatments could be effective for cardiovascular disease prevention?

Research has shown that strength training can significantly reduce the risk of heart disease. Studies have found that adults who engage in strength exercises have about a 17% lower chance of developing heart problems compared to those who do not. This trial will compare different durations of resistance exercise, with some participants engaging in 30, 60, or 120 minutes of resistance exercise per week, each combined with aerobic exercise. Another group will perform only aerobic exercise. Combining strength and aerobic exercises appears to enhance heart health further. Other research suggests that activities like strength training can lower the risk of dying from any cause by up to 17%. While aerobic exercise is already known to benefit heart health, adding strength exercises could amplify these benefits. ^{3 4 6 7 8}

Who Is on the Research Team?

Duck-chul Lee, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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) 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]

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) 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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10959113/

Resistance Training in Cardiovascular Diseases: A Review on ... This review aims to describe the effects of RT on CVD risk factors based on studies retrieved from PubMed and Google Scholar databases.

2. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001189

Resistance Exercise Training in Individuals With and ... Adults who participate in RT have ≈15% lower risk of all-cause mortality and 17% lower risk of CVD, compared with adults who report no RT.

3. academic.oup.com academic.oup.com/ehjopen/article/5/5/oeaf093/8231441

The effect of different resistance exercise training intensities ... A 0.01 increase in WHR has been associated with a 5% increase in risk of cardiovascular disease. Resistance training has been recommended as an effective ...

4. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0210292

Comparative effectiveness of aerobic, resistance, and ... Cumulatively our data suggest that concurrent aerobic and resistance training may be a more potent means to improve CVD risk factor burden among ...

5. bjsm.bmj.com bjsm.bmj.com/content/56/13/755

a systematic review and meta-analysis of cohort studies Muscle-strengthening activities were associated with a 10–17% lower risk of all-cause mortality, cardiovascular disease (CVD), total cancer, diabetes and lung ...

6. acc.org acc.org/Latest-in-Cardiology/ten-points-to-remember/2023/12/19/15/33/resistance-exercise-training

AHA Update on Resistance Exercise Training: Key Points Accumulating evidence suggests resistance training is a safe and effective approach for improving cardiovascular (CV) health in adults with and ...

7. frontiersin.org frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2021.754794/full

Efficacy and Safety of Resistance Training for Coronary ... At present, studies have found that RT reduces cardiovascular mortality, prevents obesity, reduces blood pressure, and improves insulin ...

8. academic.oup.com academic.oup.com/eurheartj/article/45/13/1127/7513891

Aerobic, resistance, or combined exercise training and ... Aerobic exercise alone or combined aerobic plus resistance exercise, but not resistance exercise alone, improved CVD risk profile (composite Z- ...