Recruiting

Remote Cardiac Rehab

Sponsor:

Children's Mercy Hospital Kansas City

Code:

NCT06015191

Conditions

Congenital Heart Disease in Children

Eligibility Criteria

Sex: All

Age: 12 - 19

Healthy Volunteers: Not accepted

Interventions

Remote Cardiac Rehabilitation

Active Control

Study Details

Brief 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

Study ID

NCT06015191

Start date

Aug 31, 2023

Status verified date

Apr, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 19

Healthy Volunteers: Not accepted

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 transannular patch 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-Friday work week
7. English Speaking
8. Achieving maximal effort on a cardiopulmonary exercise test, defined as RER ≥1.1 and/or in the judgement of the supervising exercise physiologist, a maximal effort was achieved but exercise capacity is limited by musculoskeletal deconditioning.

Exclusion Criteria:

1. Physically or developmentally unable to perform outcomes assessments or participate in 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 physical education class).
3. Height less than 132cm
4. Pregnancy or planned surgery or procedure (excluding outpatient, non-cardiac procedures) within the 12-week study period.
5. Meeting at least 1 exercise test safety or screening criteria on most recent exercise test (pre-study) or baseline outcomes visit exercise test
6. Presence of significant cardiac dysfunction that would impair safe participation in moderate-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 valvar function, 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

Enrollment

74 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Remote Cardiac Rehabilitation

Following a 2-week ramp-up period, participants will attend group exercise sessions, remotely delivered in their homes, 3 days per week for 45-minutes over 12-weeks led by a live-interactive health coach. There are 4 exercise session types with different modalities: Session A: 75% aerobic, 25% resistance; Session B: 25% aerobic, 75% resistance; Session C: 50% aerobic, 50% resistance; and Session D: Exercise games (mix of modalities). Each participant will rotate through a 5-week set of exercise sessions (20 sessions) twice over the 10-weeks of group exercise period.

active comparator: 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.

Interventions

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.

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.

Primary outcome measure

  • Peak Cardiorespiratory Fitness [ Time Frame: Change from baseline to 12-weeks ]

Central Contacts and Locations

Central contacts

Madeline Donnelli, BS

816-764-5605Remotecare@cmh.edu

David Cloutier, MS, MBA

816-302-3636dacloutier@cmh.edu

Locations

Children's Mercy Kansas City

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

David A White, PhD

8167317478dawhite@cmh.edu

More Information

Sponsor

Children's Mercy Hospital Kansas City

Last update posted

May 4, 2026

Last verified

Apr, 2026

Keywords

  • Exercise
  • Cardiac Rehabilitation
  • Physical Activity
  • Telehealth

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Children's Mercy Hospital Kansas City on 2026-05-04.