What this study is
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.
What's being tested
- Remote Cardiac Rehabilitation
Intervention · 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
Intervention · 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.
Study details
- Official title
- Remotely Delivered Cardiac Rehabilitation for Adolescents With Congenital Heart Disease
- Sponsor
- Children's Mercy Hospital Kansas City
- Conditions
- Congenital Heart Disease in Children
- Enrolling
- 74 people
- Starts
- 2023-08-31
- Est. completion
- 2027-12
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 12 Years – 19 YearsSex ALLHealthy volunteers Not acceptedYou 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 can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openChildren's Mercy Kansas City
Kansas City, Missouri, United States
- David A White, PhD · Contact8167317478dawhite@cmh.edu
- Dara Watkins, MA · Contact
Recruiting
Study team
Sponsor
Children's Mercy Hospital Kansas City
Study ID STUDY00000990
Principal investigator
David A White, PhD
Children's Mercy Kansas City
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.