Cardiac Rehabilitation Maintenance Programs for Cardiovascular Disease

(EMPOWER ME Trial)

Overseen By Kristen Walaska, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Miriam Hospital

Disqualifiers: Heart failure, Heart transplant, Dialysis, others

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

Compensation: Varies

Number of Visits: Unknown

400 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 discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Fully Automated Online Program, High Intensity Cardiac Rehabilitation Maintenance Program, Low-Intensity Cardiac Rehabilitation Maintenance Program, Text Messaging for Cardiovascular Disease?

Research shows that cardiac rehabilitation programs, which include exercise and lifestyle changes, can improve heart health and reduce the risk of future heart problems. Activity-monitoring devices and mobile apps can help patients stay active and improve health outcomes, suggesting that online and text-based programs might also be effective. ^{1 2 3 4 5}

Is cardiac rehabilitation safe for humans?

Cardiac rehabilitation programs, which include exercise and other supportive activities, are generally considered safe and beneficial for people with heart disease. They have been shown to reduce the risk of future heart problems and improve overall health, with no significant safety concerns reported in the studies reviewed. ^{6 7 8 9 10}

How is the cardiac rehabilitation maintenance program treatment different from other treatments for cardiovascular disease?

Cardiac rehabilitation maintenance programs are unique because they focus on long-term physical activity and lifestyle changes to maintain health after initial rehabilitation, unlike other treatments that may focus solely on medication or short-term interventions. These programs integrate physical activity with education and risk factor modification to reduce cardiovascular risk and improve quality of life. ^{10 11 12 13 14}

What is the purpose of this trial?

The study is sponsored by the National Heart, Lung, and Blood Institute, which is part of the National Institutes of Health. We expect to enroll 400 subjects into this study. We will be recruiting research participants that are finishing or will finish cardiac rehabilitation soon. Participants belong to one or more groups of people who are less often studied in cardiac rehabilitation research, may have less access to a formal cardiac rehabilitation maintenance program, or they may especially benefit from additional support after cardiac rehabilitation ends. The main purposes of this study are to evaluate which treatments work the best after cardiac rehabilitation, which order to deliver the treatments in, and which treatments are as minimally burdensome as possible while still working well. This study will make two comparisons (one comparison between a set of low-intensity interventions and another between a set of higher-intensity interventions) to determine which produces the best behavioral adherence immediately after Phase II (outpatient) cardiac rehabilitation

Eligibility Criteria

This trial is for individuals finishing or soon to finish cardiac rehabilitation, particularly those from underrepresented groups in cardiac rehab research, with limited access to maintenance programs, or who may benefit from extra support post-rehab. Participants must meet certain health criteria.

Inclusion Criteria

BMI ≥27

Own an internet-connected device

English proficiency

Exclusion Criteria

Current pregnancy

I have had a left ventricular assist device installed in the last 4 months.

Report of conditions that the investigators believe would render them potentially unlikely to follow the protocol including terminal illness, active substance dependence, or other significant psychiatric problems that require inpatient hospitalization

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Intervention

Participants receive either a low-intensity text messaging intervention or a fully automated online program for 2 months

8 weeks

Remote interactions

Second Intervention

Non-responders to the initial intervention receive either low-intensity or high-intensity home-based cardiac rehabilitation for 3 months

12 weeks

Remote interactions with optional virtual meetings

Follow-up

Participants are monitored for adherence to cardioprotective behaviors and other outcomes

6 months

Remote monitoring

Treatment Details

Interventions

• Fully Automated Online Program
• High Intensity Cardiac Rehabilitation Maintenance Program
• Low-Intensity Cardiac Rehabilitation Maintenance Program
• Text Messaging

Trial Overview The study compares low-intensity vs. high-intensity cardiac rehabilitation maintenance programs after outpatient rehab ends. It also tests text messaging and a fully automated online program to see which approach best maintains health improvements with minimal burden.

Participant Groups

Group I: First Intervention: Text Messaging, Second Intervention: Low-Intensity Cardiac Rehabilitation Experimental Treatment 2 Interventions

Participants receive the text messaging intervention for 2 months. Following their mid-intervention assessment, they are randomized to receive the low-intensity cardiac rehabilitation maintenance program. Patients are instructed to log in 3 times weekly to view lessons, sync their Fitbit data, and complete a home-based workout video. They track weight, PA, and medication adherence daily. Patients have access to an extensive CR resource library made and curated by the platform provider plus resources on maintaining heart healthy behaviors during Phase III created by the research team. They are reminded to log in if they log in less than twice weekly.

Group II: First Intervention: Text Messaging, Second Intervention: High-Intensity Cardiac Rehabilitation Experimental Treatment 2 Interventions

Participants receive the text messaging intervention for 2 months. Following their mid-intervention assessment, they are randomized to receive the high-intensity cardiac rehabilitation maintenance program. Patients are instructed to log in 3 times weekly to view lessons, sync their Fitbit data, and complete a home-based workout video. They track weight, PA, and medication adherence daily and attend a once weekly virtual meeting with a CR case manager. Meetings are modeled after Phase II and focus on tailored exercise prescription, addressing cognitive, behavioral, and environmental adherence barriers, and support. Patients have access to an extensive CR resource library made and curated by the platform provider plus resources on maintaining heart healthy behaviors during Phase III created by the research team. They are reminded to log in if they log in less than twice weekly.

Group III: First Intervention: Text Messaging, Second Intervention: Continued Text Messaging Experimental Treatment 1 Intervention

Participants are first randomized to the low-intensity text messaging intervention. On 3 days/week they receive a text about 1 of the 3 behaviors (weight maintenance or loss, physical activity, and medication adherence) in randomized order with guidance for maintaining or improving these behaviors to reach program-provided goals. The system compares their last week's adherence to the responder criteria. They receive feedback praising adherence and instructions for a theory-driven behavioral strategy (e.g., stimulus control) to increase adherence. Feedback is tailored to the patient's adherence or existence of self-monitoring data. Participants meeting responder criteria after 2 months will continue to receive the text messaging intervention for the next 3 months.

Group IV: First Intervention: Fully Automated Online Program (FAOP), Second Intervention: Continued FAOP Experimental Treatment 1 Intervention

Patients receiving the fully automated online program will select a weight loss or a weight maintenance curriculum based on their goals. Patients will receive 8 weeks of fully automated lessons covering the 3 key behaviors: weight (management or loss), physical activity, and medication adherence. All 3 behaviors are discussed weekly, but the lessons first prioritize PA, then weight management, and then medication adherence to mimic the emphasis in Phase II. Total weekly lesson time is 20-30 minutes. Patients retain access to lessons. They self-monitor calories, weight, moderate-to-vigorous physical activity, and medication adherence. Tracking data are seamlessly integrated into the system. They manually enter their medication adherence data and receive encouraging feedback on each of the behaviors the next week. Participants meeting responder criteria after 2 months will continue to receive the fully automated online program.

Group V: First Intervention: FAOP, Second Intervention: Low-Intensity Cardiac Rehabilitation Experimental Treatment 2 Interventions

Participants receive the fully automated online program for 2 months. Following their mid-intervention assessment, they are randomized to receive the low-intensity cardiac rehabilitation maintenance program. Patients are instructed to log in 3 times weekly to view lessons, sync their Fitbit data, and complete a home-based workout video. They track weight, PA, and medication adherence daily. Patients have access to an extensive CR resource library made and curated by the platform provider plus resources on maintaining heart healthy behaviors during Phase III created by the research team. They are reminded to log in if they log in less than twice weekly.

Group VI: First Intervention: FAOP, Second Intervention: High-Intensity Cardiac Rehabilitation Experimental Treatment 2 Interventions

Participants receive the fully automated online program intervention for 2 months. Following their mid-intervention assessment, they are randomized to receive the high-intensity cardiac rehabilitation maintenance program. Patients are instructed to log in 3 times weekly to view lessons, sync their Fitbit data, and complete a home-based workout video. They track weight, PA, and medication adherence daily and attend a once weekly virtual meeting with a CR case manager. Meetings are modeled after Phase II and focus on tailored exercise prescription, addressing cognitive, behavioral, and environmental adherence barriers, and support. Patients have access to an extensive CR resource library made and curated by the platform provider plus resources on maintaining heart healthy behaviors during Phase III created by the research team. They are reminded to log in (after they miss a login) if they log in less than twice weekly.

Who Is Running the Clinical Trial?

The Miriam Hospital

Lead Sponsor

Trials

252

Recruited

39,200+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Office of the Director, National Institutes of Health (OD)

Collaborator

Trials

2

Recruited

400+

Findings from Research

This review aims to evaluate how effective activity-monitoring devices and mobile applications are in improving physical activity and health outcomes for patients with cardiovascular disease undergoing cardiac rehabilitation, highlighting their potential role in supporting long-term exercise habits.

The review will analyze systematic reviews and meta-analyses of randomized controlled trials, ensuring a comprehensive assessment of the impact of these technologies on patient outcomes, with a focus on varying effectiveness based on patient characteristics and rehabilitation stages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of activity-monitoring devices in patients with cardiovascular disease participating in cardiac rehabilitation programs: an umbrella review protocol. Dafny, HA., Champion, S., Gebremichael, LG., et al.[2023]

Cardiac rehabilitation (CR) programs lead to improvements in fitness for patients after heart events, with a mean age of participants being 59.5 years, but younger individuals and women are underrepresented in these studies.

The study suggests that a more tailored 'Precision Medicine' approach to CR could enhance benefits for all patient subgroups, as current programs may not fully address the diverse needs of participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fit, Female or Fifty-Is Cardiac Rehabilitation "Fit" for Purpose for All? A Systematic Review and Meta-Analysis With Meta-Regression. Smith, M., Orchard, J., La Gerche, A., et al.[2022]

Cardiac rehabilitation, particularly exercise-based programs, has been shown to improve outcomes for patients who have experienced a myocardial infarction, enhancing functional capacity, psychosocial well-being, and health knowledge.

These rehabilitation programs are generally safe, especially when monitored with telemetry, and the review also highlights the potential benefits for patients beyond those with a history of myocardial infarction, including home-based rehabilitation options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of cardiac rehabilitation services. With emphasis on patients after myocardial infarction. Greenland, P., Chu, JS.[2019]

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 rehabilitation, which includes exercise training and potentially other interventions, is effective for patients with coronary heart disease, leading to significant reductions in all-cause and cardiac mortality, nonfatal reinfarction, and hospitalization rates, based on a review of 71 trials involving 13,824 patients.

Despite its effectiveness, certain groups such as the elderly, women, and those with comorbidities are underrepresented in clinical trials, highlighting the need for broader inclusion in future research and the promotion of cardiac rehabilitation by healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise-based cardiac rehabilitation in patients with coronary heart disease: meta-analysis outcomes revisited. Oldridge, N.[2022]

A standardized program content for phase II cardiac rehabilitation in Australia was developed through a comprehensive literature review and a modified Delphi process involving 16 multidisciplinary experts, resulting in 49 best practice statements.

Out of these, 29 statements were deemed essential for effective cardiac rehabilitation, ensuring that the program is evidence-based and can be reliably implemented by CR coordinators.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of standardised programme content for phase II cardiac rehabilitation programmes in Australia using a modified Delphi process. Cartledge, S., Thomas, E., Hollier, K., et al.[2020]

Cardiac rehabilitation is essential for cardiovascular care, emphasizing the need for adequate funding and evidence showing its benefits on quality of life and cost-effectiveness.

Physical activity is a key component of cardiac rehabilitation, but it should be combined with programs that modify other risk factors for optimal patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The challenge of cardiac rehabilitation. Dafoe, W.[2016]

A study of 256 patients with coronary disease showed that a 12-month exercise-based cardiac rehabilitation program significantly improved various cardiovascular risk factors, including lipid profiles and blood pressure, with these improvements maintained over time.

Despite initial improvements, body mass index changes lost statistical significance by the 6-month follow-up, indicating the need for ongoing strategies to sustain weight management in cardiac rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Long-term effects of a cardiac rehabilitation program in the control of cardiovascular risk factors]. Magalhães, S., Viamonte, S., Miguel Ribeiro, M., et al.[2013]

References

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

Effectiveness of activity-monitoring devices in patients with cardiovascular disease participating in cardiac rehabilitation programs: an umbrella review protocol. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Fit, Female or Fifty-Is Cardiac Rehabilitation "Fit" for Purpose for All? A Systematic Review and Meta-Analysis With Meta-Regression. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

[Individualization of exercise load control for inpatient cardiac rehabilitation. Development and evaluation of a HRV-based intervention program for patients with ischemic heart failure]. [2021]

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

Efficacy of cardiac rehabilitation services. With emphasis on patients after myocardial infarction. [2019]

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

First report of the International Council of Cardiovascular Prevention and Rehabilitation's Registry (ICRR). [2023]

6. England pubmed.ncbi.nlm.nih.gov

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

7. England pubmed.ncbi.nlm.nih.gov

Exercise-based cardiac rehabilitation in patients with coronary heart disease: meta-analysis outcomes revisited. [2022]

8. Australia pubmed.ncbi.nlm.nih.gov

A National Survey of Patient Data Capture, Management, Reporting Practice in Australian Cardiac Rehabilitation Programs. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Development of standardised programme content for phase II cardiac rehabilitation programmes in Australia using a modified Delphi process. [2020]

10. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Modern strategies for cardiac rehabilitation after myocardial infarction and percutaneous coronary intervention]. [2020]

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

The challenge of cardiac rehabilitation. [2016]

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

Long-term Cardiac Maintenance Programming: A SINGLE-SITE ANALYSIS OF MORE THAN 200 PARTICIPANTS. [2021]

13. Portugal pubmed.ncbi.nlm.nih.gov

[Long-term effects of a cardiac rehabilitation program in the control of cardiovascular risk factors]. [2013]

14. Australia pubmed.ncbi.nlm.nih.gov

Community-Based Cardiac Rehabilitation Maintenance Programs: Use and Effects. [2015]