Remote Cardiac Rehab for Adolescents With Congenital Heart Disease

Summary

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.

Conditions

• Congenital Heart Disease in Children

Interventions

BEHAVIORAL

Remote Cardiac Rehabilitation

Participants will engage in a ramp-up period (weeks 0-2) where participants will attend 1-on-1 live, remote in-home exercise sessions (20-35 min./session, 3-days/wk.) delivered by a health coach via telehealth video conferencing. Participants will be provided a tablet computer and a small set of equipment. Following the ramp-up period, participants will be asked to attend live, in-home, group-based exercise sessions (weeks 3-12, 3-5 participants/group, 45-min, 3-days/wk. minimum). Sessions will be offered 4-days/wk. in the afternoons and early evenings allowing participants to select the most convenient 3 days per week to attend. Sessions will include a variety of dynamic aerobic and anaerobic (resistance) exercises with a target heart rate corresponding to 60-75% of VO2peak. In the group-based exercise sessions, participants will be able to see, hear, and verbally interact with the health coach and the other participants, allowing for supervision and encouraging social support.

BEHAVIORAL

Active Control

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.

Sponsors & Collaborators

• University of Kansas

  collaborator OTHER

• Children's Hospital of Philadelphia

  collaborator OTHER

• University of North Carolina, Chapel Hill

  collaborator OTHER

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Children's Mercy Hospital Kansas City

  lead OTHER

Principal Investigators

• David A White, PhD · Children's Mercy Kansas City

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

19 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-08-31

Primary Completion

2027-06-30

Completion

2027-12-31

Countries

• United States

Study Locations