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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Remote Cardiac Rehabilitation

    Behavioral

    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.

  • Active Control

    Behavioral

    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.

Treatment groups

74 Participants
are divided into 2 treatment groups
Group A: Remote Cardiac RehabilitationExperimental treatment 1 intervention
Group B: Active ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Peak Cardiorespiratory Fitness

Cardiorespiratory fitness will be assessed using a peak cardiopulmonary exercise stress test (VO2peak) on a cycle ergometer using a ramping cycle protocol.

Time frame
Change from baseline to 12-weeks

Secondary outcomes

1

Echocardiogram with global longitudinal strain (Fontan)

Cardiac Function for the participant with Fontan diagnosis will be assessed with echocardiogram using greyscale 2-dimensional images obtained of the single left ventricle, right ventricle or the entirety of the biventricular morphology. Global longitudinal strain analysis will be performed by averaging the apical 4, 3, or 2 images using GE EchoPAC BT13 software following American Society of Echocardiography guidelines.

Time frame
Change from baseline to 12-weeks
2

Echocardiogram with global longitudinal strain (Tetralogy of Fallot and d-transposition of the great vessels)

Cardiac Function for the participant with Tetralogy of Fallot and d-transposition of the great vessels diagnosis will be assessed with echocardiogram using greyscale 2-dimensional images obtained on the ventricles. Global longitudinal strain analysis will be performed by averaging the apical 4, 3, and 2 images using GE EchoPAC BT13 software following American Society of Echocardiography guidelines.

Time frame
Change from baseline to 12-weeks
3

Lean Body Mass

Body composition will be assessed using whole-body dual energy X-ray absorptiometry (DXA)

Time frame
Change from baseline to 12-weeks
4

Frailty (slowness)

Slowness will be assessed using a 6-minute walk test

Time frame
Change from baseline to 12-weeks

Other outcomes

Sponsors and contacts

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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