74 Participants Needed

Remote Cardiac Rehabilitation for Congenital Heart Disease

(Remote-CaRe Trial)

DW
DC
Overseen ByDavid Cloutier, MS, MBA
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Children's Mercy Hospital Kansas City
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.678910

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.510111213

Who Is on the Research Team?

DA

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
See 2 more

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.
See 11 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Remote Cardiac RehabilitationExperimental Treatment1 Intervention
Group II: Active ControlActive Control1 Intervention

Find a Clinic Near You

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.
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.
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.
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]

Citations

Israel's first national remote cardiac rehabilitation program: A retrospective analysis. [2023]
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]
Telerehabilitation in patients with recent hospitalisation due to acute decompensated heart failure: protocol for the Tele-ADHF randomised controlled trial. [2023]
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]
Design of a Remote Coaching Program to Bridge the Gap From Hospital Discharge to Cardiac Rehabilitation: Intervention Mapping Study. [2022]
Safety and Feasibility of Tele-Cardiac Rehabilitation Using Remote Biological Signal Monitoring System: A Pilot Study. [2023]
Feasibility and effectiveness of remote, telephone-based delivery of cardiac rehabilitation. [2021]
Changes in patient activation following cardiac rehabilitation using the Active+me digital healthcare platform during the COVID-19 pandemic: a cohort evaluation. [2021]
Evaluating the interactive web-based program, activate your heart, for cardiac rehabilitation patients: a pilot study. [2021]
Cardiac rehabilitation using telemedicine: the need for tele cardiac rehabilitation. [2021]
The First National Program of Remote Cardiac Rehabilitation in Israel-Goal Achievements, Adherence, and Responsiveness in Older Adult Patients: Retrospective Analysis. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Cardiac Rehabilitation During Quarantine in COVID-19 Pandemic: Challenges for Center-Based Programs. [2021]
Remotely Delivered Cardiac Rehabilitation Exercise for Coronary Heart Disease: Nonrandomized Feasibility Study. [2023]
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