Impact of a Cardiac and Mental Health Rehab Program on Well-Being and Fitness in Young Adults With Fontan Circulation: A Randomized Trial
NCT ID: NCT06844149
Last Updated: 2025-02-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
36 participants
INTERVENTIONAL
2019-01-12
2020-04-28
Brief Summary
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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!
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CPR group; Cardiac and Psychosocial Rehabilitation
Cognitive Behavioral Therapy (CBT)-based psychosocial rehabilitation program with a structured Home-Based Cardiac Rehabilitation (CR) program
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
CR group; Home-Based Cardiac Rehabilitation
8-week Home-Based Cardiac Rehabilitation (CR) program
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.
Control group; usual care
control group received usual care without any additional interventions
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
Interventions
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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
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.
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
23 Years
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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June Huh
Professor of Pediatric Cardiology, Samsung Medical Center, Sungkyunkwan University School of Medicine
Locations
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Samsung Medical Center
Seoul, 서울 - Seoul, South Korea
Countries
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Other Identifiers
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KCT0006496
Identifier Type: REGISTRY
Identifier Source: secondary_id
2018-08-035---3
Identifier Type: -
Identifier Source: org_study_id
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