NCT06844149

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

Effects of a Cardiac and Psychosocial Rehabilitation Program on Depression, Anxiety, Self-Efficacy, Quality of Life, and Exercise Capacity in Young Adults With Fontan Circulation: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 23 Years
• Healthy volunteers: Not accepted

Summary

Helping Young Adults With Fontan Circulation Feel Better and Stay Active What is the study about? This study looked at how a special program could help young adults with Fontan circulation feel better mentally and physically. People with this condition often struggle with anxiety, depression, and low energy. The study tested a Cardiac and Psychosocial Rehabilitation (CPR) program, which included counseling and exercise training to improve their well-being. Who participated? 38 young adults (ages 18-23) with Fontan circulation They were divided into three groups: CPR Group - received counseling (Cognitive Behavioral Therapy, CBT) and a home exercise program CR Group - did only the home exercise program Control Group - continued with their usual care What did the study find? * Less anxiety and depression - The CPR group had the biggest improvement in mental health. * Better self-confidence (self-efficacy) - Participants felt more capable of handling challenges. * Higher quality of life - They felt happier and more engaged in daily life. ❌ No major changes in exercise ability - While they became more active, their heart fitness levels did not change much. What does this mean for patients and families? Mental health support is just as important as physical care for young adults with Fontan circulation. A combination of counseling and exercise is better than exercise alone for reducing stress and anxiety. Regular safe exercise should still be encouraged for better long-term health. For healthcare providers: This study supports adding psychological care (CBT) to standard cardiac rehabilitation. More research is needed to optimize home-based exercise programs for Fontan patients. Final message: If you or a loved one has Fontan circulation, taking care of mental health is just as important as heart health. A program that includes counseling and exercise may help improve both!

Detailed description

"All relevant information has been entered in the appropriate sections of the study record." This ensures there is no unnecessary duplication while keeping the record clear and organized.

Conditions

• Congenital Heart Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-01-12
• Primary completion: 2020-04-15
• Completion: 2020-04-28
• First posted: 2025-02-25
• Last updated: 2025-02-25

Locations

1 site across 1 country: South Korea