Remote Cardiac Rehabilitation for Congenital Heart Disease

(Remote-CaRe Trial)

Overseen By David Cloutier, MS, MBA

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Mercy Hospital Kansas City

Must not be taking: Milrinone

Disqualifiers: Pregnancy, Cardiac dysfunction, Asthma, others

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

Compensation: Varies

Number of Visits: 36

Duration: 10 weeks

74 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this randomized controlled trial is to evaluate the effectiveness of video conferencing for the delivery of live-supervised, real-time cardiac rehabilitation (CR) exercise training to groups of adolescents with congenital heart disease (CHD) in their homes. Participants will be randomized to either the remote cardiac rehab (RCR) group or active control group. The RCR group will participate in live, group-based exercise training (3-5 participants per exercise session), in their homes 3 days per week for 45 minutes over 12-weeks. Exercise sessions will be led and supervised by a live health coach via telehealth video technology. The active control group will be provided informational handouts on health exercise for their cardiac diagnosis. The primary aim is to compare between group changes (0-12-weeks) in cardiorespiratory fitness (VO2peak). Secondary aims are to compare between group changes (0-12-weeks) in cardiac function (echocardiography), lean body mass, and physical frailty. Exploratory aims will compare between group changes (0-12-weeks) in physical function, quality of life, skeletal muscle function, and physical activity self-efficacy. Additionally, exploratory aims will explore the impact of demographic characteristics, program participation, program satisfaction, and daily physical activity on changes in cardiorespiratory fitness.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude participants who are prescribed milrinone. If you are taking this medication, you would not be eligible to participate.

Is remote cardiac rehabilitation safe for humans?

Research shows that remote cardiac rehabilitation, including telehealth and home-based programs, is generally safe for people with heart conditions. Studies have evaluated its safety and feasibility, indicating it can be a safe alternative to traditional in-person programs. ^{1 2 3 4 5}

How is the Remote Cardiac Rehabilitation treatment for Congenital Heart Disease different from other treatments?

Remote Cardiac Rehabilitation is unique because it allows patients to participate in cardiac rehab from home using telemedicine, which can be more convenient and accessible than traditional in-person programs. This approach is particularly beneficial during situations like the COVID-19 pandemic, where attending in-person sessions may be challenging. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Remote Cardiac Rehabilitation for Congenital Heart Disease?

Research shows that remote cardiac rehabilitation, which includes exercise and digital support, is as effective as in-person programs for improving health outcomes in heart patients. It helps increase physical activity and quality of life, and can be especially beneficial for those who face barriers to attending traditional rehab programs. ^{5 10 11 12 13}

Who Is on the Research Team?

David A White, PhD

Principal Investigator

Children's Mercy Kansas City

Are You a Good Fit for This Trial?

Adolescents aged 12-19 with specific congenital heart diseases, internet access at home, and cleared for exercise by their cardiologist. They must be available for in-home exercises during weekdays and not have conditions like uncontrolled asthma or reliance on a pacemaker.

Inclusion Criteria

Internet access in their homes

I am between 12 and 19 years old.

Clearance for exercise from their primary cardiologist

Exclusion Criteria

I am shorter than 132cm.

You have passed at least one exercise test before starting the study.

You cannot reach the required level of breathing during exercise testing.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Ramp-up

Participants engage in a 2-week ramp-up period with live health coach sessions

2 weeks

6 sessions (virtual)

Treatment

Participants receive live-supervised, group-based exercise training via telehealth

10 weeks

30 sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term Monitoring

Participants are encouraged to wear a physical activity monitor for a minimum of 6 months

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Active Control
• Remote Cardiac Rehab

Trial Overview The trial tests if remote cardiac rehab via video conferencing is effective for adolescents with CHD. It compares live-supervised home exercise to an active control group receiving health handouts, measuring changes in fitness, heart function, body mass, and frailty over 12 weeks.

How Is the Trial Designed?

Group I: Remote Cardiac Rehabilitation Experimental Treatment 1 Intervention

Following a 2-week ramp-up period, participants will attend group exercise sessions, remotely delivered in their homes, 3 days per week for 45-minutes over 12-weeks led by a live-interactive health coach. There are 4 exercise session types with different modalities: Session A: 75% aerobic, 25% resistance; Session B: 25% aerobic, 75% resistance; Session C: 50% aerobic, 50% resistance; and Session D: Exercise games (mix of modalities). Each participant will rotate through a 5-week set of exercise sessions (20 sessions) twice over the 10-weeks of group exercise period.

Group II: Active Control Active Control 1 Intervention

Participants will receive a handout describing physical activities appropriate for their congenital heart disease diagnosis and providing recommendations consistent with the physical activity recommendations for children and adolescents.

Who Is Running the Clinical Trial?

Children's Mercy Hospital Kansas City

Lead Sponsor

Trials

261

Recruited

941,000+

Children's Hospital of Philadelphia

Collaborator

Trials

749

Recruited

11,400,000+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

University of Kansas

Collaborator

Trials

157

Recruited

332,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

A remote cardiac rehabilitation program (RCRP) involving 306 patients with coronary heart disease over 6 months led to significant improvements in exercise capacity, with metabolic equivalents increasing from 9.5 to 11.4 (p < 0.001).

Key factors for success in the RCRP included older age and the amount of aerobic exercise completed in the first month, indicating that early engagement in the program is crucial for achieving long-term goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Israel's first national remote cardiac rehabilitation program: A retrospective analysis. Nabutovsky, I., Breitner, D., Heller, A., et al.[2023]

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]

This study is evaluating the effects of cardiac telerehabilitation (CTR) combined with remote patient management (RPM) on physical functional capacity in 64 patients with chronic heart failure (CHF) after hospital admission, aiming to improve outcomes compared to RPM alone.

The CTR program includes an 18-week multidisciplinary approach with exercise training, dietary intervention, and mental health support, which is expected to enhance physical capacity and reduce hospital readmissions for CHF patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telerehabilitation in patients with recent hospitalisation due to acute decompensated heart failure: protocol for the Tele-ADHF randomised controlled trial. van Leunen, MMCJ., de Lathauwer, ILJ., Verstappen, CCAG., et al.[2023]

A randomized controlled trial will evaluate the effectiveness of a home-based walking exercise program enhanced by digital technologies, involving 100 cardiac patients, to see if it increases their daily steps and physical fitness compared to a non-digital version of the program.

The study aims to address the gap in support for patients after cardiac interventions, potentially improving their physical activity levels and self-efficacy before they enter formal cardiac rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting Physical Activity With Self-Tracking and Mobile-Based Coaching for Cardiac Surgery Patients During the Discharge-Rehabilitation Gap: Protocol for a Randomized Controlled Trial. Zhang, C., Soliman-Hamad, M., Robijns, R., et al.[2020]

Patients with coronary artery disease (CAD) have significant information and support needs after hospital discharge, particularly regarding their condition, treatment procedures, medication, physical activity, and psychological distress, as identified through interviews and literature review involving 55 participants.

A remote coaching program was developed to address these needs, focusing on educating patients about CAD, medication adherence, safe physical activities, and understanding psychosocial impacts, thereby facilitating a smoother transition from hospital discharge to cardiac rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design of a Remote Coaching Program to Bridge the Gap From Hospital Discharge to Cardiac Rehabilitation: Intervention Mapping Study. Keessen, P., van Duijvenbode, IC., Latour, CH., et al.[2022]

The pilot study involving nine patients with cardiovascular disease demonstrated that tele-cardiac rehabilitation (tele-CR) using a remote biological signal monitoring system is safe, with no instances of monitoring failures during exercise therapy.

Participants showed significant improvements in exercise capacity after three months of tele-CR, indicating that this remote approach can effectively enhance rehabilitation outcomes for patients with cardiovascular disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Feasibility of Tele-Cardiac Rehabilitation Using Remote Biological Signal Monitoring System: A Pilot Study. Nishitani-Yokoyama, M., Shimada, K., Fujiwara, K., et al.[2023]

A remote telephone-based cardiac rehabilitation (CR) program was well-received by older Veterans, with a high satisfaction rate and an 89% completion rate compared to 73% for the face-to-face program, indicating its effectiveness in engaging patients.

Both remote and face-to-face CR programs had similar costs, suggesting that remote CR can be a cost-effective alternative to traditional on-site services, especially for patients facing barriers to access.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and effectiveness of remote, telephone-based delivery of cardiac rehabilitation. Wakefield, B., Drwal, K., Scherubel, M., et al.[2021]

Using the Active+me platform alongside standard cardiac rehabilitation (CR) led to a significant increase in patient activation measures (PAM), indicating improved patient confidence and knowledge in managing their health, particularly among high-risk patients.

Participants also experienced reductions in resting blood pressure and waist circumference, along with a notable increase in self-reported physical activity levels, suggesting that Active+me effectively supports lifestyle changes in cardiac rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in patient activation following cardiac rehabilitation using the Active+me digital healthcare platform during the COVID-19 pandemic: a cohort evaluation. Frith, G., Carver, K., Curry, S., et al.[2021]

The Internet-based cardiac rehabilitation program 'Activate Your Heart' showed significant improvements in exercise capacity and quality of life among 41 participants with coronary heart disease, with notable increases in walking distance and dietary habits after 8 weeks.

Participants reported better dietary habits, with a rise in those consuming recommended amounts of fruits, vegetables, and oily fish, suggesting that the program may effectively promote healthier lifestyle choices alongside physical improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the interactive web-based program, activate your heart, for cardiac rehabilitation patients: a pilot study. Brough, C., Boyce, S., Houchen-Wolloff, L., et al.[2021]

Cardiac Rehabilitation programs are effective in improving patient outcomes, but the COVID-19 pandemic has created challenges for their implementation.

Tele Cardiac Rehabilitation and remote patient monitoring offer a practical and effective alternative to traditional in-person programs, helping to overcome barriers posed by the pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac rehabilitation using telemedicine: the need for tele cardiac rehabilitation. Thamman, R., Janardhanan, R.[2021]

In a study of 306 patients post-myocardial infarction participating in a 6-month remote cardiac rehabilitation program, older adults (average age 70) showed better compliance and achieved program goals more effectively than younger patients.

Despite the common belief that older patients struggle with technology, the results indicated that they improved their functional capacity significantly and had similar physical activity levels compared to younger patients, suggesting that age may not be a barrier to successful participation in remote rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The First National Program of Remote Cardiac Rehabilitation in Israel-Goal Achievements, Adherence, and Responsiveness in Older Adult Patients: Retrospective Analysis. Nabutovsky, I., Breitner, D., Heller, A., et al.[2022]

The COVID-19 pandemic has halted many cardiac rehabilitation (CR) programs, which are crucial for patient health, highlighting the urgent need for remote home-based CR solutions.

There is a growing body of literature supporting remote home-based CR programs, and the current health crisis presents a unique opportunity to leverage telemedicine and technology to enhance access to CR for individuals with cardiac disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac Rehabilitation During Quarantine in COVID-19 Pandemic: Challenges for Center-Based Programs. Besnier, F., Gayda, M., Nigam, A., et al.[2021]

A pilot trial involving 21 participants with coronary heart disease tested a remote cardiac rehabilitation (CR) program using the ECME-CR platform, finding that adherence to the exercise program was high in both remote (89.1%) and center-based (89.6%) groups.

While both groups showed improvements in exercise capacity measured by the 6-minute walk test, the trial did not find significant differences between the remote and center-based programs, suggesting that remote CR may be a feasible option for those less likely to attend traditional programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remotely Delivered Cardiac Rehabilitation Exercise for Coronary Heart Disease: Nonrandomized Feasibility Study. Giggins, OM., Doyle, J., Smith, S., et al.[2023]

Citations

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

Israel's first national remote cardiac rehabilitation program: A retrospective analysis. [2023]

2. 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]

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

Telerehabilitation in patients with recent hospitalisation due to acute decompensated heart failure: protocol for the Tele-ADHF randomised controlled trial. [2023]

4. Canada pubmed.ncbi.nlm.nih.gov

Promoting Physical Activity With Self-Tracking and Mobile-Based Coaching for Cardiac Surgery Patients During the Discharge-Rehabilitation Gap: Protocol for a Randomized Controlled Trial. [2020]

5. Canada pubmed.ncbi.nlm.nih.gov

Design of a Remote Coaching Program to Bridge the Gap From Hospital Discharge to Cardiac Rehabilitation: Intervention Mapping Study. [2022]

6. Canada pubmed.ncbi.nlm.nih.gov

Safety and Feasibility of Tele-Cardiac Rehabilitation Using Remote Biological Signal Monitoring System: A Pilot Study. [2023]

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

Feasibility and effectiveness of remote, telephone-based delivery of cardiac rehabilitation. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Changes in patient activation following cardiac rehabilitation using the Active+me digital healthcare platform during the COVID-19 pandemic: a cohort evaluation. [2021]

9. Canada pubmed.ncbi.nlm.nih.gov

Evaluating the interactive web-based program, activate your heart, for cardiac rehabilitation patients: a pilot study. [2021]

10. Singapore pubmed.ncbi.nlm.nih.gov

Cardiac rehabilitation using telemedicine: the need for tele cardiac rehabilitation. [2021]

11. Canada pubmed.ncbi.nlm.nih.gov

The First National Program of Remote Cardiac Rehabilitation in Israel-Goal Achievements, Adherence, and Responsiveness in Older Adult Patients: Retrospective Analysis. [2022]

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

Cardiac Rehabilitation During Quarantine in COVID-19 Pandemic: Challenges for Center-Based Programs. [2021]

13. Canada pubmed.ncbi.nlm.nih.gov

Remotely Delivered Cardiac Rehabilitation Exercise for Coronary Heart Disease: Nonrandomized Feasibility Study. [2023]