Clinical trial NCT05968521: Cardiac Rehabilitation for Young People
Official title: Cardiac Rehabilitation for Young People: A Single-Blind Randomised Acceptability and Feasibility Study of an Integrated Physical and Mental Health Approach
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Congenital Heart Disease
Cardiomyopathies
Cardiac Arrythmias
Heart Failure
Cerebrovascular Event
Heart Valve Diseases
Keywords: Cardiac Rehabilitation
Metacognitive Therapy
Mental health
Feasibility
Congenital Heart Disease
Lead sponsor: Greater Manchester Mental Health NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
name: University of Manchester
name: University of York
First posted: 2023-08-01
Enrollment: 100
Sex: ALL
Minimum age (years): 11
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: OTHER

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.


Eligibility criteria: All participants meeting the following inclusion criteria and aged between 11-16 years old will be eligible:

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

Those with a formal diagnosis or under assessment for any above exclusion criteria will be excluded.

Primary outcomes:
measure: Recruitment Rate (Feasibility Outcome)
timeFrame: Date of Baseline Assessment to end of follow-up (24 week follow up)
measure: Retention Rate (Feasibility Outcome)
timeFrame: Date of Baseline Assessment to end of follow-up (24 week follow up)
measure: Intervention Attendance (Feasibility Outcome)
timeFrame: Date of Baseline Assessment to end of follow-up (24 week follow up)
measure: Acceptability of the Intervention
timeFrame: Date of Baseline Assessment to end of follow-up (24 week follow up)
Secondary outcomes:
measure: Strength and Difficulties Questionnaire (SDQ)
timeFrame: Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up)
measure: Paediatric Quality of Life (PedsQol)
timeFrame: Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up)
measure: Six minute walk test (6MWT)
timeFrame: Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up)
measure: Incremental Shuttle Walk Test (ISWT)
timeFrame: Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up)
measure: Physical Activity Monitoring
timeFrame: Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up)
measure: Metacognition Questionnaire-Adolescent (MCQ-A)
timeFrame: Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up)
measure: Child Health Utility-9D (CHU-9D)
timeFrame: Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up)
measure: Health and Social Care Service-Use Questionnaire
timeFrame: Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up)
measure: Demographics Questionnaire
timeFrame: Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up)
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust
Study officials:
affiliation: Greater Manchester Mental Health Foundation Trust
name: Lora Capobianco, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Manchester
name: Adrian Wells, PhD
role: PRINCIPAL_INVESTIGATOR
References: