Remote Cardiac Rehabilitation for Congenital Heart Disease
(Remote-CaRe Trial)
Recruiting in Palo Alto (17 mi)
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Children's Mercy Hospital Kansas City
Must not be taking: Milrinone
Disqualifiers: Pregnancy, Cardiac dysfunction, Asthma, others
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
26789How 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.
110111213Eligibility Criteria
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
+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.
+11 more
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Remote Cardiac RehabilitationExperimental Treatment1 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 ControlActive Control1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Children's Mercy Kansas CityKansas City, MO
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Who Is Running the Clinical Trial?
Children's Mercy Hospital Kansas CityLead Sponsor
Children's Hospital of PhiladelphiaCollaborator
University of North Carolina, Chapel HillCollaborator
University of KansasCollaborator
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
References
Israel's first national remote cardiac rehabilitation program: A retrospective analysis. [2023]Cardiac rehabilitation is an essential component of secondary prevention consistently unexploited by most eligible patients. Accordingly, the remote cardiac rehabilitation program (RCRP) was developed to create optimal conditions for remote instruction and supervision for patients to enable successful completion of the program.
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]Exercise-based cardiac rehabilitation improves clinical outcomes and quality of life. Technology-enabled delivery of remote cardiac rehabilitation is as effective in improving health outcomes as in-person delivery and has the potential to transform clinical service delivery. However, for the successful translation of research to clinical practice, interventions must be adequately reported in the literature.
Telerehabilitation in patients with recent hospitalisation due to acute decompensated heart failure: protocol for the Tele-ADHF randomised controlled trial. [2023]Cardiac rehabilitation in patients with chronic heart failure (CHF) has favourable effects on exercise capacity, the risk at hospital (re-)admission and quality of life. Although cardiac rehabilitation is generally recommended it is still under-utilised in daily clinical practice, particularly in frail elderly patients after hospital admission, mainly due to low referral and patient-related barriers. Cardiac telerehabilitation (CTR) has the potential to partially solve these barriers. The purpose of this study is to evaluate the effects of CTR as compared to standard remote care after hospital admission on physical functional capacity in CHF patients.
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]Home-based cardiac rehabilitations (CRs) with digital technologies have been researched and implemented to replace, augment, and complement traditional center-based CR in recent years with considerable success. One problem that technology-enhanced home-based CR can potentially address is the gap between cardiac interventions and formal CR programs. In the Netherlands and some other countries (eg, Australia), patients after cardiac interventions stay at home for 3-4 weeks without much support from their physicians, and often engage in very little physical activity (PA). A home-based exercise program enabled by digital technologies may help patients to better prepare for the later center-based CR programs, potentially increasing the uptake rate of those programs.
Design of a Remote Coaching Program to Bridge the Gap From Hospital Discharge to Cardiac Rehabilitation: Intervention Mapping Study. [2022]Remote coaching might be suited for providing information and support to patients with coronary artery disease (CAD) in the vulnerable phase between hospital discharge and the start of cardiac rehabilitation (CR).
Safety and Feasibility of Tele-Cardiac Rehabilitation Using Remote Biological Signal Monitoring System: A Pilot Study. [2023]Cardiac rehabilitation (CR) is categorized as a class I recommendation in the guidelines for the management of patients with cardiovascular disease (CVD). However, the penetration rate of outpatient CR is low in Japan. We designed a pilot study to evaluate the safety and feasibility of tele-CR using a remote biological signal monitoring system.
Feasibility and effectiveness of remote, telephone-based delivery of cardiac rehabilitation. [2021]Cardiac rehabilitation (CR) provides significant benefit for persons with cardiovascular disease. However, access to CR services may be limited by driving distance, costs, need for a driver, time away from work, or being a family primary caregiver. The primary aim of the project was to test the reach (i.e., patient and provider uptake), effectiveness (safety and clinical outcomes), and implementation (time and costs) of a remote telephone-based Phase 2 CR program. A secondary aim was to compare outcomes between patients attending the remote program (home-CR) and those attending an on-site program (comparison group).
Changes in patient activation following cardiac rehabilitation using the Active+me digital healthcare platform during the COVID-19 pandemic: a cohort evaluation. [2021]Label="BACKGROUND" NlmCategory="BACKGROUND">Restrictions on face-to-face contact, due to COVID-19, led to a rapid adoption of technology to remotely deliver cardiac rehabilitation (CR). Some technologies, including Active+me, were used without knowing their benefits. We assessed changes in patient activation measure (PAM) in patients participating in routine CR, using Active+me. We also investigated changes in PAM among low, moderate, and high risk patients, changes in cardiovascular risk factors, and explored patient and healthcare professional experiences of using Active+me.
Evaluating the interactive web-based program, activate your heart, for cardiac rehabilitation patients: a pilot study. [2021]Conventional cardiac rehabilitation (CR) programs are traditionally based on time-constrained, structured, group-based programs, usually set in hospitals or leisure centers. Uptake for CR remains poor, despite the ongoing evidence demonstrating its benefits. Additional alternative forms of CR are needed. An Internet-based approach may offer an alternative mode of delivering CR that may improve overall uptake. Activate Your Heart (AYH) is a Web-based CR program that has been designed to support individuals with coronary heart disease (CHD).
Cardiac rehabilitation using telemedicine: the need for tele cardiac rehabilitation. [2021]Cardiac Rehabilitation programs have shown to improve outcomes. The COVID-19 pandemic has posed barriers to these programs. A virtual platform might be a good solution to these challenges. Tele Cardiac Rehabilitation and remote patient monitoring provide an excellent alternative practical solution.
The First National Program of Remote Cardiac Rehabilitation in Israel-Goal Achievements, Adherence, and Responsiveness in Older Adult Patients: Retrospective Analysis. [2022]Remote cardiac rehabilitation (RCR) after myocardial infarction is an innovative Israeli national program in the field of telecardiology. RCR is included in the Israeli health coverage for all citizens. It is generally accepted that telemedicine programs better apply to younger patients because it is thought that they are more technologically literate than are older patients. It has also previously been thought that older patients have difficulty using technology-based programs and attaining program goals.
Cardiac Rehabilitation During Quarantine in COVID-19 Pandemic: Challenges for Center-Based Programs. [2021]Because of the coronavirus disease 2019 (COVID-19) epidemic, many cardiac rehabilitation (CR) services and programs are stopped. Because CR is a class I level A recommendation with clinical benefits that are now well documented, the cessation of CR programs can lead to dramatic consequences in terms of public health. We propose here a viewpoint of significant interest about the sudden need to develop remote home-based CR programs both in clinical research and in clinical care routine. This last decade, the literature on remote home-based CR programs has been increasing, but to date only clinical research experiences have been implemented. Benefits are numerous and the relevance of this approach has obviously increased with the actual health emergency. The COVID-19 crisis, the important prevalence of smartphones, and high-speed Internet during confinement should be viewed as an opportunity to promote a major shift in CR programs with the use of telemedicine to advance the health of a larger number of individuals with cardiac disease.
Remotely Delivered Cardiac Rehabilitation Exercise for Coronary Heart Disease: Nonrandomized Feasibility Study. [2023]Exercise-based cardiac rehabilitation (CR) is recommended for coronary heart disease (CHD). However, poor uptake of and poor adherence to CR exercise programs have been reported globally. Delivering CR exercise classes remotely may remove some of the barriers associated with traditional hospital- or center-based CR.