Remotely Delivered Cardiac Rehabilitation for Adolescents With Congenital Heart Disease

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 19
Healthy Volunteers: f
View:

• 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.

Locations
United States
Missouri
Children's Mercy Kansas City
RECRUITING
Kansas City
Contact Information
Primary
Dara Watkins, MA
djwatkins@cmh.edu
816-302-3633
Backup
David Cloutier, MS, MBA
dacloutier@cmh.edu
816-302-3636
Time Frame
Start Date: 2023-08-31
Estimated Completion Date: 2027-12
Participants
Target number of participants: 74
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Children's Mercy Hospital Kansas City
Collaborators: Children's Hospital of Philadelphia, University of Kansas, National Heart, Lung, and Blood Institute (NHLBI), University of North Carolina, Chapel Hill

This content was sourced from clinicaltrials.gov