Clinical trial NCT06844149: Impact of a Cardiac and Mental Health Rehab Program on Well-Being and Fitness in Young Adults With Fontan Circulation: A Randomized Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Disease
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 23
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

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!

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Change in Depression Score Assessed by the Hospital Anxiety and Depression Scale (HADS-
timeFrame: Baseline, Week 8 (Post-Intervention), Week 12 (Follow-Up)
Secondary outcomes:
measure: Change in Anxiety Score Assessed by the Hospital Anxiety and Depression Scale (HADS-A)
timeFrame: Baseline, Week 8 (Post-Intervention), Week 12 (Follow-Up)
measure: Change in Self-Efficacy Score Assessed by the General Self-Efficacy Scale (GSE)
timeFrame: Baseline, Week 8 (Post-Intervention), Week 12 (Follow-Up)
measure: Change in Quality of Life Score Assessed by the Linear Analog Scale (LAS)
timeFrame: Baseline, Week 8 (Post-Intervention), Week 12 (Follow-Up)
measure: Change in Exercise Capacity Assessed by Cardiopulmonary Exercise Testing (CPET)
timeFrame: Baseline, Week 8 (Post-Intervention), Week 12 (Follow-Up)
measure: Change in Physical Activity Level Assessed by the International Physical Activity Questionnaire (IPAQ) Short Form
timeFrame: Baseline, Week 8 (Post-Intervention), Week 12 (Follow-Up)
measure: Change in Heart Rate Variability (HRV) Assessed by Electrocardiographic Monitoring
timeFrame: Baseline, Week 8 (Post-Intervention), Week 12 (Follow-Up)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: 서울 - Seoul
Study officials:
References: