Clinical trial NCT06015191: Remote Cardiac Rehab for Adolescents With Congenital Heart Disease
Official title: Remotely Delivered Cardiac Rehabilitation for Adolescents With Congenital Heart Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Congenital Heart Disease in Children
Keywords: Exercise
Cardiac Rehabilitation
Physical Activity
Telehealth
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
Collaborators: name: University of Kansas
name: Children's Hospital of Philadelphia
name: University of North Carolina, Chapel Hill
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-08-29
Enrollment: 74
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Peak Cardiorespiratory Fitness
timeFrame: Change from baseline to 12-weeks
Secondary outcomes:
measure: Echocardiogram with global longitudinal strain (Fontan)
timeFrame: Change from baseline to 12-weeks
measure: Echocardiogram with global longitudinal strain (Tetralogy of Fallot and d-transposition of the great vessels)
timeFrame: Change from baseline to 12-weeks
measure: Lean Body Mass
timeFrame: Change from baseline to 12-weeks
measure: Frailty (slowness)
timeFrame: Change from baseline to 12-weeks
measure: Frailty (weakness)
timeFrame: Change from baseline to 12-weeks
measure: Frailty (fatigue)
timeFrame: Change from baseline to 12-weeks
measure: Frailty (energy expenditure/physical activity)
timeFrame: Change from baseline to 12-weeks
measure: Functional Movement
timeFrame: Change from baseline to 12-weeks
measure: Quality of Life Generic Core Scale
timeFrame: Change from baseline to 12-weeks
measure: Quality of Life Cardiac Module
timeFrame: Change from baseline to 12-weeks
measure: Physical Activity Self-Efficacy
timeFrame: Change from baseline to 12-weeks
measure: Exercise session adherence (Remote Cardiac Rehab Group)
timeFrame: Baseline to 12-weeks
measure: Lifestyle Physical Activity
timeFrame: Change from baseline to 12-weeks and change from 12-weeks to 6-months post intervention
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Kansas City
state: Missouri
Study officials:
affiliation: Children's Mercy Kansas City
name: David A White, PhD
role: PRINCIPAL_INVESTIGATOR
References: