Exercise Training Modalities for Cardiovascular Disease

Overseen By Sean Heffron, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Atherosclerotic CVD, Serious medical conditions, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests various aerobic exercise methods to help reduce heart disease risk. It compares in-person workouts with remote exercise training options, such as app-based and live-streamed sessions, to determine the most effective and user-friendly approach. The study welcomes participants who haven't met heart health activity guidelines and have risk factors like high blood pressure, high cholesterol, Type 2 diabetes, smoking, obesity, or a family history of early heart disease. Participants will engage in one exercise method for 12 weeks and provide feedback on its effectiveness and ease of use. As an unphased trial, this study offers a unique opportunity to explore innovative exercise methods that could enhance heart health and overall well-being.

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 seems likely that you can continue your medications, especially since the trial includes people using anti-hypertensive and diabetes medications.

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

Research has shown that remote exercise programs are generally safe for individuals at risk of heart disease. These programs include online and app-based workouts. Studies have found that participants in home-based heart rehab programs express high satisfaction and adhere well to their exercise plans.

In the Asynchronous Remote Aerobic Exercise Intervention, research found that remote exercises are safe and effective. Participants managed their workouts with occasional feedback from trainers.

For the Remote MyZone Aerobic Exercise Intervention, studies indicate that heart rate-monitored exercises are safe when properly supervised. This method uses an app to provide real-time feedback and motivation, helping participants safely adjust their workout intensity.

The Remote Synchronous Aerobic Exercise Intervention, involving live-streamed sessions, has also proven safe. Participants in remote exercise programs reported better access to health care and found them easy to use.

Overall, these remote training methods are not only safe but also user-friendly, making them a promising option for those seeking to improve heart health without visiting a gym. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these exercise training modalities for cardiovascular disease because they offer innovative, flexible ways to engage patients. Traditional cardiac rehab often requires in-person sessions, but these new methods include remote options that provide real-time feedback and allow patients to exercise at home. The Remote MyZone Aerobic Exercise Intervention, for example, uses a heart rate monitor and app for instant intensity guidance and motivation through social features. Meanwhile, the Remote Synchronous Aerobic Exercise Intervention offers live-streamed sessions with immediate trainer feedback, making it feel like a live class from the comfort of your home. These advancements aim to make cardiac rehabilitation more accessible, convenient, and engaging for patients.

What evidence suggests that this trial's exercise training modalities could be effective for cardiovascular disease?

Studies have shown that exercise-based cardiac rehabilitation (CR) can reduce the risk of dying from heart disease. This trial compares different exercise training modalities for cardiovascular disease. Research indicates that remote exercise programs, such as those using apps and heart rate monitors, are as effective as in-person sessions. In this trial, participants in the Remote MyZone Aerobic Exercise Intervention (RMZAEI) will use the Myzone program, which offers personalized feedback and social features to motivate individuals, leading to better exercise habits and fitness levels. Participants in the Remote Synchronous Aerobic Exercise Intervention (RSAEI) will join live virtual sessions with real-time guidance, which have been shown to improve exercise capacity. These programs are safe for people with heart disease and can enhance heart health when used regularly. ^{1 2 3 4 6}

Who Is on the Research Team?

Sean P. Heffron, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for individuals at risk for Cardiovascular Disease who are not currently meeting the American Heart Association guidelines for physical activity. Participants will be randomly assigned to one of four exercise training modalities and must undergo Cardiopulmonary Exercise Testing before and after the 12-week program.

Inclusion Criteria

Not meeting AHA physical activity guidelines for at least 3 months prior to screening

I am older than 45 years.

I am at risk for heart disease due to factors like high blood pressure, high cholesterol, diabetes, smoking, obesity, or family history.

Exclusion Criteria

Presence of any serious medical conditions that would not allow safe participation in exercise according to ACSM and AHA guidelines

Pregnant or anticipating pregnancy

Presence of any biopsychosocial factors that the principal investigator deems as having significant potential to interfere with effective study participation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 12 weeks of aerobic training using one of four modalities: In-Person Supervised, Asynchronous Remote, Remote MyZone, or Remote Synchronous.

12 weeks

Regular virtual or in-person sessions depending on the modality

Follow-up

Participants are monitored for changes in physical activity, cardiovascular fitness, and CVD risk, and respond to questions regarding acceptability of the interventions.

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Remote Exercise Training Modalities

Trial Overview

The study tests the acceptability and effectiveness of different aerobic training methods: a smart-device app (MyZone), asynchronous virtual classes, synchronous virtual classes, in-person sessions, using Myzone heart rate monitors or Map My Fitness app over a period of 12 weeks.

How Is the Trial Designed?

Group I: Remote Synchronous Aerobic Exercise Intervention (RSAEI) Experimental Treatment 2 Interventions

Participants join live-streamed exercise sessions led by a virtual trainer. Real-time heart rate monitoring via an app allows the trainer to provide immediate feedback and adjust exercise intensity as needed.

Group II: Remote MyZone Aerobic Exercise Intervention (RMZAEI) Experimental Treatment 2 Interventions

Participants use the Myzone heart rate monitor and app to receive real-time feedback on their exercise intensity. The Myzone platform provides automated guidance on intensity adjustments, goal setting, and motivational support through features like challenges and social connectivity.

Group III: Asynchronous Remote Aerobic Exercise Intervention (RASAEI) Experimental Treatment 2 Interventions

Participants exercise independently while monitoring their heart rate in real time using the Map My Fitness app. They adjust their intensity based on personal targets and receive periodic feedback from a trainer during scheduled check-ins.

Group IV: In-Person Supervised Aerobic Exercise Intervention (IPSAEI) Active Control 2 Interventions

Participants engage in supervised exercise sessions at a facility, where trainers use centralized telemetry to monitor heart rates and provide immediate feedback and adjustments to exercise intensity.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

Cardiac telerehabilitation significantly improves long-term cardiopulmonary fitness in patients with coronary artery disease (CAD), showing a mean difference of 1.61 in peak oxygen uptake compared to traditional center-based rehabilitation.

Patients participating in cardiac telerehabilitation also experience an improvement in quality of life, with a mean difference of 0.92, while maintaining a high completion rate of 80% and a low incidence of adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longer-Term Effects of Cardiac Telerehabilitation on Patients With Coronary Artery Disease: Systematic Review and Meta-Analysis. Zhong, W., Liu, R., Cheng, H., et al.[2023]

A smartphone-guided training system (GEX) for cardiac rehabilitation (CR) was found to be feasible and safe, with no training-related complications reported during the study involving 118 patients with coronary artery disease.

Patients using the GEX system showed a significant improvement in exercise capacity (peak VO2) compared to those receiving conventional CR, indicating that remote monitoring can enhance rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-based training of coronary artery patients: the Heart Cycle Trial. Skobel, E., Knackstedt, C., Martinez-Romero, A., et al.[2022]

Cardiac rehabilitation (CR) programs significantly reduce future cardiac events and mortality, but only about 10% of eligible patients participate due to geographical barriers.

The development of virtual CR programs, utilizing technologies like the Internet and smartphones, shows promise in improving patient access and has demonstrated positive effects on clinical outcomes in small randomized trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Delivery of Cardiac Rehabilitation Using Communications Technologies: The "Virtual" Cardiac Rehabilitation Program. Lear, SA.[2019]

A pilot study involving 15 patients showed that an Internet-based virtual cardiac rehabilitation program (vCRP) is safe and feasible, with no adverse events reported during the 12-week study.

Participants in the vCRP significantly improved key health metrics, including cholesterol levels and exercise capacity, achieving results comparable to traditional cardiac rehabilitation programs, indicating its potential as an effective alternative for patients unable to attend in-person sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilization of the internet to deliver cardiac rehabilitation at a distance: a pilot study. Zutz, A., Ignaszewski, A., Bates, J., et al.[2022]

Regular exercise training is highly recommended for heart failure patients, supported by strong evidence, yet many patients remain inactive due to various barriers.

Home telerehabilitation is proposed as an effective solution to encourage physical activity among heart failure patients, addressing the limitations of traditional outpatient rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to do: telerehabilitation in heart failure patients. Piotrowicz, E.[2019]

Remote cardiac rehabilitation using technology can effectively improve cardiovascular fitness, as shown in a systematic review of 12 randomized trials involving 1588 participants.

However, the reporting quality of these interventions is inadequate, with no trial fully meeting the TIDieR checklist, which raises concerns about the ability to replicate these studies in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Completeness of intervention reporting in randomised trials of technology-enabled remote or hybrid exercise-based cardiac rehabilitation: a systematic review using the TIDieR framework. McGrath, A., McHale, S., Hanson, CL., et al.[2023]

Citations

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This study aims to assess the feasibility and effectiveness of a 12-week asynchronous remotely supervised exercise and patient education program

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This study aims to investigate the impact of remote exercise rehabilitation on time investment and related cognitive levels in homebound patients with CHD.

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Exercise Training Modalities for Cardiovascular Disease

Research shows that exercise training, including remote and virtual programs, is generally safe for people with cardiovascular disease when properly monitored.

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