Cardiac Rehabilitation for Young People

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-04

Study Completion Date

2024-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Congenital Heart Disease Cardiomyopathies Cardiac Arrythmias Heart Failure Cerebrovascular Event Heart Valve Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study is a single blind parallel randomised feasibility trial comparing a CR programme against usual care with 100 CYP (50 per arm) aged 11-16 diagnosed with a heart condition.

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Blinding of allocation will be maintained for the principal investigator's, statistician, and quantitative research assistant.

Study Groups

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Cardiac Rehabilitation (Intervention)

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

Group Type EXPERIMENTAL

Cardiac Rehabilitation (CR): Experimental

Intervention Type BEHAVIORAL

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.

Treatment as usual (Control)

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

Group Type ACTIVE_COMPARATOR

Treatment as usual: Control

Intervention Type BEHAVIORAL

Treatment as usual will include routine clinical outpatient management.

Interventions

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Cardiac 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.

Intervention Type BEHAVIORAL

Treatment as usual: Control

Treatment as usual will include routine clinical outpatient management.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

11 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No