Cardiac rehabilitation program for young people with heart conditions
Cardiac Rehabilitation for Young People: A Single-Blind Randomised Acceptability and Feasibility Study of an Integrated Physical and Mental Health Approach
This study is testing a new exercise and mental health program for kids and teens with heart conditions to see if it helps them feel better and live healthier lives compared to standard treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 11 Years to 16 Years |
| Sex | All |
| Sponsor | Greater Manchester Mental Health NHS Foundation Trust Academic / other |
| Locations | 1 site (Manchester) |
| Trial ID | NCT05968521 on ClinicalTrials.gov |
What this trial studies
This study aims to develop and test the feasibility and acceptability of a cardiac rehabilitation program specifically designed for children and young people aged 11-16 with various heart conditions. The program combines exercise with mental health support to address both physical and psychological challenges faced by this population. By focusing on improving health behaviors and mental well-being, the study seeks to enhance the quality of life for participants and reduce the risk of additional health issues. The intervention will be compared to standard treatment to evaluate its effectiveness.
Who should consider this trial
Good fit: Ideal candidates for this study are children and young people aged 11-16 who have been diagnosed with congenital heart disease, cardiomyopathy, cardiac arrhythmias, heart failure, or have experienced a cerebrovascular event.
Not a fit: Patients with significant safeguarding concerns, head injuries, or severe social and communication difficulties may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve the physical and mental health outcomes for young people with heart conditions.
How similar studies have performed: While there is limited data on similar programs specifically for young people, adult cardiac rehabilitation programs have shown success, suggesting potential for positive outcomes in this demographic.
Eligibility criteria
Show full inclusion / exclusion criteria
All participants meeting the following inclusion criteria and aged between 11-16 years old will be eligible: Inclusion Criteria: 1. Fluent in English 2. Consent to participate 3. Diagnosed with at least one of the following: * Congenital heart disease (all subtypes) * Cardiomyopathy * Cardiac arrhythmia * Heart failure * Post-cerebrovascular event * Post-heart valve repair/replacement Exclusion Criteria: 1. Significant risk or safeguarding concerns (i.e., suicidal ideation) 2. Head injury/organic impairment 3. Significant social and/or communication difficulties Those with a formal diagnosis or under assessment for any above exclusion criteria will be excluded.
Where this trial is running
Manchester
- Manchester University NHS Foundation Trust — Manchester, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Lora Capobianco, PhD — Greater Manchester Mental Health Foundation Trust
- Study coordinator: Lora Capobianco, PhD
- Email: lora.capobianco@gmmh.nhs.uk
- Phone: 01610046664
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.