Cardiac Rehabilitation for Young People
NCT05968521 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2024-03-07
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.
Conditions
- Congenital Heart Disease
- Cardiomyopathies
- Cardiac Arrythmias
- Heart Failure
- Cerebrovascular Event
- Heart Valve Diseases
Interventions
- BEHAVIORAL
-
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.
- BEHAVIORAL
-
Treatment as usual: Control
Treatment as usual will include routine clinical outpatient management.
Sponsors & Collaborators
-
National Institute for Health Research, United Kingdom
collaborator OTHER_GOV -
University of Manchester
collaborator OTHER -
University of York
collaborator OTHER -
Greater Manchester Mental Health NHS Foundation Trust
lead OTHER
Principal Investigators
-
Lora Capobianco, PhD · Greater Manchester Mental Health Foundation Trust
-
Adrian Wells, PhD · University of Manchester
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 11 Years
- Max Age
- 16 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-03-04
- Primary Completion
- 2024-08-31
- Completion
- 2024-11-30
Countries
- United Kingdom
Study Locations
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