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Congenital Heart Disease(NCTXXXXXXXX)NCT06844149

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

A study testing CPR; (Cardiac and Psychosocial Rehabilitation) with Cardiac Rehabilitation and CR; Home-Based Cardiac Rehabilitation in people with Congenital Heart Disease, run by Samsung Medical Center at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 23 years
Conditions the study is for
Congenital Heart Disease
What is being tested?
CPR; (Cardiac and Psychosocial Rehabilitation) with Cardiac Rehabilitation and CR; Home-Based Cardiac Rehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteSouth Korea
Study dates
12 Jan 2019to 28 Apr 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 23 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Samsung Medical Center

    Seoul, 서울 - Seoul, 06351

Other trials in South Korea

About this study

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

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?

Read more

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!

Read the 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.

Being tested
CPR; (Cardiac and Psychosocial Rehabilitation) with Cardiac Rehabilitation, CR; Home-Based Cardiac Rehabilitation, Usual Care
Medical subject headings
Heart Defects, Congenital

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CPR; (Cardiac and Psychosocial Rehabilitation) with Cardiac RehabilitationBehavioural

    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

  • CR; Home-Based Cardiac RehabilitationBehavioural

    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.

  • Usual CareBehavioural

    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

Study groups in NCT06844149
Study groupRoleWhat they receive
CPR group; Cardiac and Psychosocial RehabilitationExperimentalCognitive Behavioral Therapy (CBT)-based psychosocial rehabilitation program with a structured Home-Based Cardiac Rehabilitation (CR) program
Receives: Behavioral: CPR; (Cardiac and Psychosocial Rehabilitation) with Cardiac Rehabilitation
CR group; Home-Based Cardiac RehabilitationExperimental8-week Home-Based Cardiac Rehabilitation (CR) program
Receives: Behavioral: CR; Home-Based Cardiac Rehabilitation
Control group; usual careExperimentalcontrol group received usual care without any additional interventions
Receives: Behavioral: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

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

Secondary outcomes (6)

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

    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.

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

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

    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.

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

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

    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).

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

  4. Change in Exercise Capacity Assessed by Cardiopulmonary Exercise Testing (CPET)

    Exercise capacity will be measured using Cardiopulmonary Exercise Testing (CPET), assessing maximal oxygen uptake (VO₂ max), exercise duration, and metabolic equivalents (METs).

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

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

    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).

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

  6. Change in Heart Rate Variability (HRV) Assessed by Electrocardiographic Monitoring

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2025
  2. Study start12 Jan 2019
  3. Primary completion15 Apr 2020
  4. Study completion28 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06844149
Sponsor's protocol ID
2018-08-035---3
Other IDs
KCT0006496
Acronym
(NCTXXXXXXXX)
Status last verified
Feb 2025
First submitted
19 Feb 2025
Last updated
25 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A study testing CPR; (Cardiac and Psychosocial Rehabilitation) with Cardiac Rehabilitation and CR; Home-Based Cardiac Rehabilitation in people with Congenital Heart Disease, run by Samsung Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Depression Score Assessed by the Hospital Anxiety and Depression Scale (HADS- (time frame: Baseline, Week 8 (Post-Intervention), Week 12 (Follow-Up)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06844149.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.

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