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Remote Cardiac Rehab for Adolescents With Congenital Heart Disease

Study acronym: Remote-CaRe
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv6
  2. Secondary endpoints: details revised at 2 of 13 entries
    • Site contact updated
    v5
  3. Primary completion date: Jan 2027 to Jun 2027
    • Study completion date: Jun 2027 to Dec 2027
    • Collaborators: 3 to 4
    v4
  4. Eligibility criteria expanded, about 28 wordsv3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Aug 2023 to Aug 31, 2023
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06015191
Lead Sponsor Children's Mercy Hospital Kansas City
Collaborators: University of Kansas, Children's Hospital of Philadelphia, University of North Carolina, Chapel Hill, National Heart, Lung, and Blood Institute (NHLBI)
Conditions
(from sponsor)		 Congenital Heart Disease in Children
Related terms Motor Activity
Enrollment 74 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov