Remote Cardiac Rehab for Adolescents With Congenital Heart Disease

NCT06015191 | Recruiting DMC

• 2 other identifiers: STUDY00000990K23HL159325-01A1
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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

Keywords

Exercise; Cardiac Rehabilitation; Physical Activity; Telehealth

Outcome Measures

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.

  Change from baseline to 12-weeks

Secondary Outcomes (13)

• Echocardiogram with global longitudinal strain (Fontan)

  Change from baseline to 12-weeks

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

  Change from baseline to 12-weeks

• Lean Body Mass

  Change from baseline to 12-weeks

• Frailty (slowness)

  Change from baseline to 12-weeks

• Frailty (weakness)

  Change from baseline to 12-weeks

Study Arms (2)

Remote Cardiac Rehabilitation

EXPERIMENTAL

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.

Behavioral: Remote Cardiac Rehabilitation

Active Control

ACTIVE COMPARATOR

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.

Behavioral: Active Control

Interventions

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.

Also known as: RCR

Remote Cardiac Rehabilitation

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.

Active Control

Eligibility Criteria

• Age: 12 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 12-19 years old
• Male or Female
• 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
• Primary Cardiology clearance for exercise participation
• Internet access in their homes
• Available for in-home exercise between 4-7pm on at least 3 days of the Monday-Friday work week
• English Speaking
• 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.

You may not qualify if:

• 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.
• Meeting at least 1 exercise test safety or screening criteria on most recent exercise test (pre-study) or baseline outcomes visit exercise test
• Presence of significant cardiac dysfunction that would impair safe participation in moderate-to-vigorous intensity exercise
• 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
• Uncontrolled or poorly controlled asthma
• Presence of implanted cardioverter-defibrillator
• Pacemaker with rate-responsive function initiated
• Reliance on ventricular assist device
• Prescribed milrinone medication
• Listed for heart transplantation
• Active engagement in hormone replacement for gender transition

Sponsors & Collaborators

• University of Kansas: collaborator
• Children's Mercy Hospital Kansas City: lead
• Children's Hospital of Philadelphia: collaborator
• University of North Carolina, Chapel Hill: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Children's Mercy Kansas City

Kansas City, Missouri, 64108, United States

RECRUITING

Related Links

• Video describing the Remote CaRe clinical trial

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• David A White, PhD

  Children's Mercy Kansas City

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Madeline Donnelli, BS

CONTACT

816-764-5605; Remotecare@cmh.edu

David Cloutier, MS, MBA

CONTACT

816-302-3636; dacloutier@cmh.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Exercise Physiologist

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: August 29, 2023
• Study Start: August 31, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)