NCT06015191

Remote Cardiac Rehab for Adolescents With Congenital Heart Disease

Remotely Delivered Cardiac Rehabilitation for Adolescents With Congenital Heart Disease

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: Children's Mercy Hospital Kansas City · Academic / Other
• Sex: All
• Age: 12 Years – 19 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This randomized controlled trial will evaluate the effectiveness of live, in-home, group-based cardiac rehabilitation (CR) exercise training compared to standard care (active) control. Participants will include adolescents (age 12-19 years) with one of three congenital heart disease (CHD) diagnoses: Fontan (single ventricle) circulation, Tetralogy of Fallot, or dextro-transposition of the great vessels. Following baseline outcomes testing, participants will be computer randomized (with equal stratification by CHD diagnosis and biologic sex) to either the remote cardiac rehab (RCR) group (n=\~37) or the active control group (n=\~37). Participants randomized to the RCR group will participate in 12-weeks of live-supervised exercise training (36 sessions total) from their respective homes led by a trained health coach via telehealth video technology. RCR participants will initially engage in a 2-week ramp-up period (1-1 or small groups, 6-sessions total) with a live health coach, followed by 10-weeks of group-based (3-5 participants, 30 sessions total) exercise training where participants will be able to interact with the health coach and other participants. Participants in the RCR group will be asked to attend and participate in exercise sessions 3 days per week for 45-minutes. Exercise session intensity will be consistent with a heart rate of 60-75% of their VO2peak, will consist of a mix of flexibility, aerobic, and anaerobic exercise, and will be facilitated by a small set of exercise equipment (e.g., resistance bands, cones, medicine balls) provided to participants. Participants randomized to the active control group will be provided handouts that describe exercises consistent with the physical activity recommendations for youth. The total intervention period for both groups will be 12-weeks. Primary, secondary, and exploratory outcomes will be measured at baseline and 12-13-weeks following randomization. Additionally, participants in both groups will be provided a consumer grade wrist-worn physical activity monitor, where participants will be encouraged to wear throughout the 12-week intervention period and beyond for a minimum of 6-months. Participants randomized to the active control group will be provided the opportunity to participate in the RCR exercise training once enrollment goals are met.

Conditions

• Congenital Heart Disease in Children

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-08-31
• Primary completion: 2027-06-01
• Completion: 2027-12-01
• First posted: 2023-08-29
• Last updated: 2025-05-11

Locations

1 site across 1 country: United States