Remote Cardiac Rehab for Adolescents With Congenital Heart Disease

Last updated: May 7, 2025
Sponsor: Children's Mercy Hospital Kansas City
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Remote Cardiac Rehabilitation

Active Control

Clinical Study ID

NCT06015191
STUDY00000990
K23HL159325-01A1
  • Ages 12-19
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 12-19 years old

  2. Male or Female

  3. Diagnosed with one of three congenital heart diseases: Univentricular heart with Fontan Palliation Tetralogy of Fallot with transannularpatch Dextro-transposition of the great arteries with arterial switch operation

  4. Primary Cardiology clearance for exercise participation

  5. Internet access in their homes

  6. Available for in-home exercise between 4-7pm on at least 3 days of the Monday-Fridaywork week

  7. English Speaking

  8. Achieving maximal effort on a cardiopulmonary exercise test, defined as RER ≥1.1and/or in the judgement of the supervising exercise physiologist, a maximal effortwas achieved but exercise capacity is limited by musculoskeletal deconditioning.

Exclusion

Exclusion Criteria:

  1. Physically or developmentally unable to perform outcomes assessments or participatein moderate-to-vigorous intensity physical activity

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

  3. Height less than 132cm

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

  5. Meeting at least 1 exercise test safety or screening criteria on most recentexercise test (pre-study) or baseline outcomes visit exercise test

  6. Presence of significant cardiac dysfunction that would impair safe participation inmoderate-to-vigorous intensity exercise

  7. Significant changes baseline echocardiogram or most recent clinical echocardiogram (from past clinical echocardiogram) such as decrease in ventricular and/or valvarfunction, new obstruction, or any new structural abnormalities

  8. Uncontrolled or poorly controlled asthma

  9. Presence of implanted cardioverter-defibrillator

  10. Pacemaker with rate-responsive function initiated

  11. Reliance on ventricular assist device

  12. Prescribed milrinone medication

  13. Listed for heart transplantation

  14. Active engagement in hormone replacement for gender transition

Study Design

Total Participants: 74
Treatment Group(s): 2
Primary Treatment: Remote Cardiac Rehabilitation
Phase:
Study Start date:
August 31, 2023
Estimated Completion Date:
December 31, 2027

Study 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.

Connect with a study center

  • Children's Mercy Kansas City

    Kansas City, Missouri 64108
    United States

    Active - Recruiting

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