RecruitingNot ApplicableNCT05968521

Cardiac Rehabilitation for Young People

Cardiac Rehabilitation for Young People: A Single-Blind Randomised Acceptability and Feasibility Study of an Integrated Physical and Mental Health Approach


Sponsor

Greater Manchester Mental Health NHS Foundation Trust

Enrollment

100 participants

Start Date

Mar 4, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Heart problems are amongst the most common physical illnesses in children and young people (CYP). They can be present from birth or develop as CYP get older and are linked to increased physical and psychological difficulties overprotection from caregivers and healthcare providers and reduced quality of life. While adults are offered exercise classes and lifestyle advice after a heart problem, CYP with heart problems are not. Improving health behaviours in people with heart problems is vital, improves quality of life and reduces additional illnesses (i.e obesity, diabetes). Approximately 1 in 3 CYP with heart problems have anxiety and/or depression so it is also important to support their mental health. One way to do this is to develop and test the acceptability and feasibility of a trial of cardiac rehabilitation (CR) consisting of exercise with mental health support for CYP. The aim is to develop and test the feasibility and acceptability of a trial of a cardiac rehabilitation programme for CYP.


Eligibility

Min Age: 11 YearsMax Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This study is exploring whether a cardiac rehabilitation program — a structured program of exercise, education, and support — can benefit young people aged 11 to 16 who have heart conditions. Cardiac rehabilitation is widely used in adults after heart events, but it is not well-studied in children and teenagers. This research aims to see if it is feasible and helpful for young patients with a range of heart conditions. **You may be eligible if...** - You are between 11 and 16 years old - You are fluent in English - You have been diagnosed with at least one of the following: congenital heart disease, cardiomyopathy, cardiac arrhythmia, heart failure, a past stroke, or a history of heart valve repair or replacement - You and your parent or guardian are willing to give consent to participate **You may NOT be eligible if...** - There are significant concerns about your safety or wellbeing (e.g., suicidal thoughts) - You have a brain injury or significant cognitive impairment - You have significant social or communication difficulties that would prevent participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALCardiac Rehabilitation (CR): Experimental

CR will consist of six sessions lasting 90 minutes of a structured exercise programme, educational and lifestyle modules, and a psychological component. Sessions include group discussions, experiential learning and homework tasks that participants are asked to complete between sessions. Participants in this treatment arm will also receive routine clinical outpatient management alongside CR.

BEHAVIORALTreatment as usual: Control

Treatment as usual will include routine clinical outpatient management.


Locations(1)

Manchester University NHS Foundation Trust

Manchester, United Kingdom

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NCT05968521


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