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

Not Applicable

Completed

• Conditions: Congenital Heart Disease

• Registration Number: NCT06844149
• Lead Sponsor: Samsung Medical Center

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.

Study Timeline

• Study Start: 2019-01-12
• Primary Completion: 2020-04-15
• Study Completion: 2020-04-28
• Status Verified: 2025-02
• Study First Submitted: 2025-02-19
• Study First Submitted QC: 2025-02-19
• Last Update Submitted: 2025-02-19
• Study First Posted: 2025-02-25
• Last Update Posted: 2025-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Depression Score Assessed by the Hospital Anxiety and Depression Scale (HADS-	Baseline, Week 8 (Post-Intervention), Week 12 (Follow-Up)	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)

Secondary Outcome Measures

Name	Time	Method
Change in Anxiety Score Assessed by the Hospital Anxiety and Depression Scale (HADS-A)	Baseline, Week 8 (Post-Intervention), Week 12 (Follow-Up)	Anxiety will be measured using the Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-A). The HADS-A consists of 7 items, each scored from 0 to 3, with a total score ranging from 0 to 21. Higher scores indicate greater anxiety symptoms.
Change in Self-Efficacy Score Assessed by the General Self-Efficacy Scale (GSE)	Baseline, Week 8 (Post-Intervention), Week 12 (Follow-Up)	Self-efficacy will be measured using the General Self-Efficacy Scale (GSE), a validated 10-item questionnaire scored on a scale from 1 to 4, with a total possible score of 10 to 40. Higher scores indicate greater self-efficacy.
Change in Quality of Life Score Assessed by the Linear Analog Scale (LAS)	Baseline, Week 8 (Post-Intervention), Week 12 (Follow-Up)	Quality of life (QOL) will be measured using the Linear Analog Scale (LAS), a 10-cm visual analog scale ranging from 0 (worst) to 100 (best).
Change in Heart Rate Variability (HRV) Assessed by Electrocardiographic Monitoring	Baseline, Week 8 (Post-Intervention), Week 12 (Follow-Up)	Heart rate variability (HRV) was assessed using electrocardiographic (ECG) monitoring. HRV parameters include time-domain (e.g., standard deviation of NN intervals \[SDNN\], root mean square of successive differences \[RMSSD\]) and frequency-domain measures (e.g., low-frequency \[LF\], high-frequency \[HF\] power). Higher HRV indicates better autonomic function and cardiovascular health.
Change in Exercise Capacity Assessed by Cardiopulmonary Exercise Testing (CPET)	Baseline, Week 8 (Post-Intervention), Week 12 (Follow-Up)	Exercise capacity will be measured using Cardiopulmonary Exercise Testing (CPET), assessing maximal oxygen uptake (VO₂ max), exercise duration, and metabolic equivalents (METs).
Change in Physical Activity Level Assessed by the International Physical Activity Questionnaire (IPAQ) Short Form	Baseline, Week 8 (Post-Intervention), Week 12 (Follow-Up)	Physical activity (PA) was measured using the International Physical Activity Questionnaire (IPAQ) short form. The IPAQ categorizes PA levels as vigorous, moderate, or walking and quantifies total activity in metabolic equivalent of task minutes per week (MET-min/week).

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, 서울 - Seoul, Korea, Republic of