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

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

What data supports the effectiveness of the treatment Remote Exercise Training Modalities for cardiovascular disease?

Research shows that remote exercise training, like telerehabilitation, can improve exercise capacity and quality of life for heart patients, similar to traditional in-person programs. It is especially helpful for those who can't attend center-based programs, making it a promising option for increasing access to cardiac rehabilitation. ^{1 2 3 4 5}

Is exercise training safe for people with cardiovascular disease?

Research shows that exercise training, including remote and virtual programs, is generally safe for people with cardiovascular disease when properly monitored. Studies have found no adverse events in participants, even among high-risk patients, as long as there is adequate medical supervision. ^{6 7 8 9 10}

How does remote exercise training differ from other treatments for cardiovascular disease?

Remote exercise training is unique because it allows patients to participate in cardiac rehabilitation from their homes using technology like smartphones and the internet, making it more accessible for those who cannot attend traditional in-person programs. This approach uses tools like heart rate monitors to track progress and provide feedback, potentially improving exercise capacity and adherence to the program. ^{3 5 10 11 12}

What is the purpose of this trial?

This study will investigate the acceptability and efficacy of 12 weeks of: Smart-device app-based (MyZone) Asynchronous Virtual, Synchronous Virtual, and in-person aerobic training in individuals at risk for Cardiovascular Disease (CVD) who do are not meeting American Heart Association (AHA) guidelines for physical activity. The study aims to 1) Assess the effect of several approaches to remote aerobic training on measures of physical activity, cardiovascular fitness and CVD risk, and 2) Quantitatively and qualitatively evaluate exercise training program fidelity, implementation, effectiveness, and remaining barriers to acceptance. Participants will be asked to undergo Cardiopulmonary Exercise Testing (CPET) before and after 12-weeks of training via one of the 4 modalities (random assignment) listed above. They will respond to questions regarding acceptability of the interventions.

Research Team

Sean P. Heffron, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. Poland pubmed.ncbi.nlm.nih.gov

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

2. England pubmed.ncbi.nlm.nih.gov

Effects and costs of home-based training with telemonitoring guidance in low to moderate risk patients entering cardiac rehabilitation: The FIT@Home study. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Cardiac telerehabilitation: current situation and future challenges. [2013]

4. England 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. [2023]

5. Japan pubmed.ncbi.nlm.nih.gov

Internet-based training of coronary artery patients: the Heart Cycle Trial. [2022]

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

Assessment of ECG during hybrid comprehensive telerehabilitation in heart failure patients-Subanalysis of the Telerehabilitation in Heart Failure Patients (TELEREH-HF) randomized clinical trial. [2021]

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

Utilization of the internet to deliver cardiac rehabilitation at a distance: a pilot study. [2022]

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

Exercise Prescription in Patients with Different Combinations of Cardiovascular Disease Risk Factors: A Consensus Statement from the EXPERT Working Group. [2021]

9. Sweden pubmed.ncbi.nlm.nih.gov

Can high-risk patients after myocardial infarction participate in comprehensive cardiac rehabilitation? [2022]

10. England pubmed.ncbi.nlm.nih.gov

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

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

Effect of home-based high-intensity interval training using telerehabilitation among coronary heart disease patients. [2022]

12. Canada pubmed.ncbi.nlm.nih.gov

Longer-Term Effects of Cardiac Telerehabilitation on Patients With Coronary Artery Disease: Systematic Review and Meta-Analysis. [2023]