Cardiac Rehabilitation for Young People (CardioActive)

Greater Manchester Mental Health NHS Foundation Trust

Status: Enrolling

Conditions: Heart Valve Diseases; Cerebrovascular Event; Cardiac Arrythmias; Heart Failure; Congenital Heart Disease; Cardiomyopathies

Treatments: Behavioral: Cardiac Rehabilitation (CR): Experimental; Behavioral: Treatment as usual: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT05968521

X638s

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 11 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Cardiac Rehabilitation (Intervention)

Experimental group

Description:

Participants allocated to the intervention group will receive a cardiac rehabilitation (CR) programme which will involve education, exercise, and a psychological component.

Treatment:

Behavioral: Cardiac Rehabilitation (CR): Experimental

Treatment as usual (Control)

Active Comparator group

Description:

Participants allocated to the control group will receive treatment as usual.

Treatment:

Behavioral: Treatment as usual: Control