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

NCT06844149 | Completed DMC

• 2 other identifiers: 2018-08-035---3KCT0006496
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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!

Conditions

Congenital Heart Disease

Outcome Measures

Primary Outcomes (1)

• Change in Depression Score Assessed by the Hospital Anxiety and Depression Scale (HADS-

  Depression will be measured using the Hospital Anxiety and Depression Scale - Depression subscale (HADS-D). The HADS-D consists of 7 items, each scored from 0 to 3, with a total score ranging from 0 to 21. Higher scores indicate greater depressive symptoms. The primary outcome will be assessed at three time points: pre-intervention, post-intervention (week 8), and follow-up (week 12)

  Baseline, Week 8 (Post-Intervention), Week 12 (Follow-Up)

Secondary Outcomes (6)

• Change in Anxiety Score Assessed by the Hospital Anxiety and Depression Scale (HADS-A)

  Baseline, Week 8 (Post-Intervention), Week 12 (Follow-Up)

• Change in Self-Efficacy Score Assessed by the General Self-Efficacy Scale (GSE)

  Baseline, Week 8 (Post-Intervention), Week 12 (Follow-Up)

• Change in Quality of Life Score Assessed by the Linear Analog Scale (LAS)

  Baseline, Week 8 (Post-Intervention), Week 12 (Follow-Up)

• Change in Exercise Capacity Assessed by Cardiopulmonary Exercise Testing (CPET)

  Baseline, Week 8 (Post-Intervention), Week 12 (Follow-Up)

• Change in Physical Activity Level Assessed by the International Physical Activity Questionnaire (IPAQ) Short Form

  Baseline, Week 8 (Post-Intervention), Week 12 (Follow-Up)

Study Arms (3)

CPR group; Cardiac and Psychosocial Rehabilitation

EXPERIMENTAL

Cognitive Behavioral Therapy (CBT)-based psychosocial rehabilitation program with a structured Home-Based Cardiac Rehabilitation (CR) program

Behavioral: CPR; (Cardiac and Psychosocial Rehabilitation) with Cardiac Rehabilitation

CR group; Home-Based Cardiac Rehabilitation

EXPERIMENTAL

8-week Home-Based Cardiac Rehabilitation (CR) program

Behavioral: CR; Home-Based Cardiac Rehabilitation

Control group; usual care

EXPERIMENTAL

control group received usual care without any additional interventions

Behavioral: Usual Care

Interventions

CPR; (Cardiac and Psychosocial Rehabilitation) with Cardiac Rehabilitation BEHAVIORAL

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

CPR group; Cardiac and Psychosocial Rehabilitation

CR; Home-Based Cardiac Rehabilitation BEHAVIORAL

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.

CR group; Home-Based Cardiac Rehabilitation

Usual Care BEHAVIORAL

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

Control group; usual care

Eligibility Criteria

• Age: 18 Years - 23 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 18 to 23 years more than one year after Fontan surgery
• Had no surgery planned during study participation
• Had scores ≥ 8 for the anxiety (HADS-A) and/or depression (HADS-D) HADS subscales (Bjelland, Dahl, Haug, \& Neckelmann, 2002; Holdgaard et al., 2023).
• Could read and complete the consent form and questionnaire, and participate in a Korean-language group

You may not qualify if:

• Undergoing psychotherapy during study participation
• Had significant cognitive impairment, psychosis, or personality disorder noted in their medical record
• Had scores ≥ 11 for HADS-D and \> 17 for the Beck Depression Inventory (BDI) as evaluated by a psychiatrist or had been identified with severe depression or other serious psychiatric diagnoses (Kovacs et al., 2022; Marquez et al., 2020).
• Exhibited indications for the restriction of exercise of greater-than-moderate intensity based on recommendations from the American Heart Association (Franklin et al., 2020; Longmuir et al., 2013)

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 서울 - Seoul, 06351, South Korea

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Cardiopulmonary Resuscitation; Psychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Resuscitation; Emergency Treatment; Therapeutics; Rehabilitation; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: "Not Applicable - This is an open-label study."
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatric Cardiology, Samsung Medical Center, Sungkyunkwan University School of Medicine

Model Details: This study used a parallel assignment model in which participants were randomly assigned to one of three groups: (1) a combined Cardiac and Psychosocial Rehabilitation (CPR) group, (2) a Cardiac Rehabilitation (CR) only group, or (3) a usual care control group. Each group received its assigned intervention throughout the study without crossover

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: February 25, 2025
• Study Start: January 12, 2019
• Primary Completion: April 15, 2020
• Study Completion: April 28, 2020
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

KR (1)