NCT05968521

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Greater Manchester Mental Health NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 11 Years – 16 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2024-03-04
• Primary completion: 2024-08-31
• Completion: 2024-11-30
• First posted: 2023-08-01
• Last updated: 2024-03-07

Locations

1 site across 1 country: United Kingdom