Cardiac Rehabilitation for Young People

NCT05968521 | Recruiting

• 1 other identifier: X638s
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• Recruitment Rate (Feasibility Outcome)

  Feasibility will be assessed using recruitment rate (i.e., number of patients consented and randomized, number of patients declined the study).

  Date of Baseline Assessment to end of follow-up (24 week follow up)

• Retention Rate (Feasibility Outcome)

  Feasibility will be assessed using retention rates (i.e., number of patients withdrawn from the study, lost to follow up)

  Date of Baseline Assessment to end of follow-up (24 week follow up)

• Intervention Attendance (Feasibility Outcome)

  Feasibility will be assessed using participant attendance at intervention (i.e., number of sessions attended at the intervention).

  Date of Baseline Assessment to end of follow-up (24 week follow up)

• Acceptability of the Intervention

  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.

  Date of Baseline Assessment to end of follow-up (24 week follow up)

Secondary Outcomes (9)

• Strength and Difficulties Questionnaire (SDQ)

  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)

• Six minute walk test (6MWT)

  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)

Study Arms (2)

Cardiac Rehabilitation (Intervention)

EXPERIMENTAL

Participants allocated to the intervention group will receive a cardiac rehabilitation (CR) programme which will involve education, exercise, and a psychological component.

Behavioral: Cardiac Rehabilitation (CR): Experimental

Treatment as usual (Control)

ACTIVE COMPARATOR

Participants allocated to the control group will receive treatment as usual.

Behavioral: Treatment as usual: Control

Interventions

Cardiac Rehabilitation (CR): Experimental BEHAVIORAL

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.

Cardiac Rehabilitation (Intervention)

Treatment as usual: Control BEHAVIORAL

Treatment as usual will include routine clinical outpatient management.

Treatment as usual (Control)

Eligibility Criteria

• Age: 11 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Significant risk or safeguarding concerns (i.e., suicidal ideation)
• Head injury/organic impairment
• Significant social and/or communication difficulties

Sponsors & Collaborators

• Greater Manchester Mental Health NHS Foundation Trust: lead
• National Institute for Health Research, United Kingdom: collaborator
• University of Manchester: collaborator
• University of York: collaborator

Study Sites (1)

Manchester University NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

RECRUITING

Related Publications (1)

• Capobianco L, Hann M, McManus E, Peters S, Doherty PJ, Ciotti G, Murray J, Wells A. Cardiac rehabilitation for children and young people (CardioActive): protocol for a single-blind randomised feasibility and acceptability study of a centre-based cardiac rehabilitation programme versus usual care in 11-16 years with heart conditions. BMJ Open. 2024 Feb 24;14(2):e077958. doi: 10.1136/bmjopen-2023-077958.

  PMID: 38401897 DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital; Cardiomyopathies; Heart Failure; Heart Valve Diseases; Psychological Well-Being

Interventions

Cardiac Rehabilitation; Therapeutics

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Lora Capobianco, PhD

  Greater Manchester Mental Health Foundation Trust

  PRINCIPAL INVESTIGATOR

• Adrian Wells, PhD

  University of Manchester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lora Capobianco, PhD

CONTACT

01610046664; lora.capobianco@gmmh.nhs.uk

Adrian Wells, PhD

CONTACT

01612765399; adrian.wells@manchester.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinding of allocation will be maintained for the principal investigator's, statistician, and quantitative research assistant.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: August 1, 2023
• Study Start: March 4, 2024
• Primary Completion: August 31, 2024
• Study Completion: November 30, 2024
• Last Updated: March 7, 2024

Record last verified: 2024-03

Locations

GB (1)