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

February 19, 2025 updated by: June Huh, Samsung Medical Center

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

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!

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • 서울 - Seoul
      • Seoul, 서울 - Seoul, Korea, Republic of, 06351
        • Samsung Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CPR group; Cardiac and Psychosocial Rehabilitation
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
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
Experimental: CR group; Home-Based Cardiac Rehabilitation
8-week Home-Based Cardiac Rehabilitation (CR) program
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.
Experimental: Control group; usual care
control group received usual care without any additional interventions
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Depression Score Assessed by the Hospital Anxiety and Depression Scale (HADS-
Time Frame: 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)
Baseline, Week 8 (Post-Intervention), Week 12 (Follow-Up)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Anxiety Score Assessed by the Hospital Anxiety and Depression Scale (HADS-A)
Time Frame: 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.
Baseline, Week 8 (Post-Intervention), Week 12 (Follow-Up)
Change in Self-Efficacy Score Assessed by the General Self-Efficacy Scale (GSE)
Time Frame: 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.
Baseline, Week 8 (Post-Intervention), Week 12 (Follow-Up)
Change in Quality of Life Score Assessed by the Linear Analog Scale (LAS)
Time Frame: 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).
Baseline, Week 8 (Post-Intervention), Week 12 (Follow-Up)
Change in Exercise Capacity Assessed by Cardiopulmonary Exercise Testing (CPET)
Time Frame: 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).
Baseline, Week 8 (Post-Intervention), Week 12 (Follow-Up)
Change in Physical Activity Level Assessed by the International Physical Activity Questionnaire (IPAQ) Short Form
Time Frame: 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).
Baseline, Week 8 (Post-Intervention), Week 12 (Follow-Up)
Change in Heart Rate Variability (HRV) Assessed by Electrocardiographic Monitoring
Time Frame: 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.
Baseline, Week 8 (Post-Intervention), Week 12 (Follow-Up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2019

Primary Completion (Actual)

April 15, 2020

Study Completion (Actual)

April 28, 2020

Study Registration Dates

First Submitted

February 19, 2025

First Submitted That Met QC Criteria

February 19, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 19, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-08-035---3
  • KCT0006496 (Registry Identifier: https://cris.nih.go.kr/)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) related to primary and secondary outcomes will be shared upon reasonable request. Researchers can request access to the data by contacting the Principal Investigator

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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