Impact of a Cardiac and Mental Health Rehab Program on Well-Being and Fitness in Young Adults With Fontan Circulation: A Randomized Trial

NACompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

January 12, 2019

Primary Completion Date

April 15, 2020

Study Completion Date

April 28, 2020

Conditions
Congenital Heart Disease
Interventions
BEHAVIORAL

CPR; (Cardiac and Psychosocial Rehabilitation) with Cardiac Rehabilitation

This intervention combines an 8-week Cognitive Behavioral Therapy (CBT)-based psychosocial rehabilitation program with a structured Home-Based Cardiac Rehabilitation (CR) program for young adults with Fontan circulation. The CBT component includes weekly 90-minute group sessions focusing on stress management, cognitive restructuring, and social coping skills. The CR component consists of a personalized aerobic exercise plan, starting at 15-30 minutes per session and progressing to 40-60 minutes, with weekly monitoring and adjustments. This combined intervention is provided exclusively to participants in the CPR group

BEHAVIORAL

CR; Home-Based Cardiac Rehabilitation

This intervention consists of an 8-week Home-Based Cardiac Rehabilitation (CR) program designed for young adults with Fontan circulation. Participants follow a structured aerobic exercise plan tailored to their cardiopulmonary fitness levels. The program starts with 15-30 minutes of exercise per session, progressing to 40-60 minutes, with intensity set at 60-70% of maximum heart rate. Exercise adherence is monitored through weekly follow-ups, with adjustments made as needed. This intervention is provided to participants in both the CR group and the CPR group but without the Cognitive Behavioral Therapy (CBT) component in the CR-only group.

BEHAVIORAL

Usual Care

Participants in the control group received usual care without any additional interventions. They did not participate in the Cognitive Behavioral Therapy (CBT)-Based Psychosocial Rehabilitation or the Home-Based Cardiac Rehabilitation (CR) programs during the study period. After the study was completed, they were given the option to enroll in the CPR program. This group serves as a comparison to evaluate the effectiveness of the interventions in the CPR and CR groups

Trial Locations (1)

06351

Samsung Medical Center, Seoul

All Listed Sponsors
lead

Samsung Medical Center

OTHER

NCT06844149 - Impact of a Cardiac and Mental Health Rehab Program on Well-Being and Fitness in Young Adults With Fontan Circulation: A Randomized Trial | Biotech Hunter | Biotech Hunter