Cardiac Rehabilitation for Young People: A Single-Blind Randomised Acceptability and Feasibility Study of an Integrated Physical and Mental Health Approach
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Retention Rate (Feasibility Outcome)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
Masking Description
Blinding of allocation will be maintained for the principal investigator's, statistician, and quantitative research assistant.
Eligibility Criteria
- Ages
- 11 Years to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All participants meeting the following inclusion criteria and aged between 11-16 years old will be eligible:
- •Inclusion Criteria:
- •Fluent in English
- •Consent to participate
- •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
- •Significant risk or safeguarding concerns (i.e., suicidal ideation)
- •Head injury/organic impairment
- •Significant social and/or communication difficulties
- •Those with a formal diagnosis or under assessment for any above exclusion criteria will be excluded.
Arms & Interventions
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.
Intervention: Cardiac Rehabilitation (CR): Experimental (Behavioral)
Treatment as usual (Control)
Participants allocated to the control group will receive treatment as usual.
Intervention: Treatment as usual: Control (Behavioral)
Outcomes
Primary Outcomes
Retention Rate (Feasibility Outcome)
Time Frame: Date of Baseline Assessment to end of follow-up (24 week follow up)
Feasibility will be assessed using retention rates (i.e., number of patients withdrawn from the study, lost to follow up)
Intervention Attendance (Feasibility Outcome)
Time Frame: Date of Baseline Assessment to end of follow-up (24 week follow up)
Feasibility will be assessed using participant attendance at intervention (i.e., number of sessions attended at the intervention).
Recruitment Rate (Feasibility Outcome)
Time Frame: Date of Baseline Assessment to end of follow-up (24 week follow up)
Feasibility will be assessed using recruitment rate (i.e., number of patients consented and randomized, number of patients declined the study).
Acceptability of the Intervention
Time Frame: Date of Baseline Assessment to end of follow-up (24 week follow up)
Acceptability of the intervention will be assessed in qualitative semi-structured interviews with children and young people, caregivers, and healthcare professionals, which will assess individuals views on the intervention, targets for improvement, and perceived acceptability of the components of the cardiac rehabilitation programme.
Secondary Outcomes
- Strength and Difficulties Questionnaire (SDQ)(Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up))
- Child Health Utility-9D (CHU-9D)(Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up))
- Incremental Shuttle Walk Test (ISWT)(Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up))
- Physical Activity Monitoring(Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up))
- Metacognition Questionnaire-Adolescent (MCQ-A)(Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up))
- Health and Social Care Service-Use Questionnaire(Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up))
- Demographics Questionnaire(Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up))
- Six minute walk test (6MWT)(Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up))
- Paediatric Quality of Life (PedsQol)(Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up))
Investigators
Lora Capobianco
Principal Investigator
Greater Manchester Mental Health NHS Foundation Trust