CompletedNot Applicable

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

South Korea36 participantsStarted 2019-01-12

Plain-language 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!

Who can participate

Age range

18 Years – 23 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Depression Score Assessed by the Hospital Anxiety and Depression Scale (HADS-

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

Trial details

NCT IDNCT06844149

SponsorSamsung Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-04-15

View on ClinicalTrials.gov More Congenital Heart Disease trials