Cardiac Rehabilitation for Young People

NCT05968521 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-03-07

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05968521 on ClinicalTrials.gov