Remote Cardiac Rehab for Adolescents With Congenital Heart Disease

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-19
SponsorChildren's Mercy Hospital Kansas City

About 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.

Eligibility criteria

Qualifiers

Age 12-19 years old

Male or Female

Primary Cardiology clearance for exercise participation

Internet access in their homes

Disqualifiers

Physically or developmentally unable to perform outcomes assessments or participate in moderate-to-vigorous intensity physical activity

Participating in > 15 MET-hours per week (mean weekly average over the past 12-months) of organized athletic/exercise activity (not including school physical education class).

Height less than 132cm

Pregnancy or planned surgery or procedure (excluding outpatient, non-cardiac procedures) within the 12-week study period.

Trial design

Treatments tested in this trial

  • Remote Cardiac Rehabilitation
  • Active Control

Treatment groups

74 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Children's Mercy Hospital Kansas City

Lead sponsor

University of Kansas

Collaborator

Children's Hospital of Philadelphia

Collaborator

University of North Carolina, Chapel Hill

Collaborator

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator