Cardiac rehabilitation for children and young people

Cardiac rehabilitation for young people: a single-blind randomised acceptability and feasibility study of an integrated physical and mental health approach

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN50031147

Enrollment

100

Registered

2023-04-13

Start date

2024-03-01

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular and mental health in children and young people Not Applicable

Interventions

Cardiac rehabilitation (CR) will consist of six sessions delivered weekly, with each session lasting between 60-90 minutes. CR consists of a structured group-based exercise programme and accompanying

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged between 11-16 years 2. Fluent in English 3. Consent given to participate 4. Diagnosed with at least one of the following: 4.1. Congenital heart disease (all subtypes) 4.2. Cardiomyopathy 4.3. Cardiac arrhythmia 4.4. Heart failure 4.5. Post-cerebrovascular event 4.6. Post-heart valve repair/replacement

Exclusion criteria

Exclusion criteria: Current exclusion criteria as of 06/07/2023: 1. Significant risk or safeguarding concerns (i.e. suicidal ideation) 2. Head injury/organic impairment 3. Significant communication and/or social difficulties Note: Those with a formal diagnosis or under assessment for any above exclusion criteria will be excluded. _____ Previous exclusion criteria as of 26/05/2023: 1. Significant risk or safeguarding concerns (i.e., suicidal ideation) 2. Head injury/organic impairment 3. Learning disability causing communication difficulties Note: Those with a formal diagnosis or under assessment for any above exclusion criteria will be excluded. ____ Previous exclusion criteria: 1. Significant risk or safeguarding concerns (i.e., suicidal ideation) 2. Head injury/organic impairment 3. Autism Spectrum Disorder Note: Those with a formal diagnosis or under assessment for any above exclusion criteria will be excluded.

Design outcomes

Primary

Measure	Time frame
Current primary outcome measures as of 06/07/2023: The following primary outcome measures will be assessed from baseline to end of follow-up: 1. Feasibility will be assessed using referral rates (baseline), recruitment and retention rates (baseline, 12 weeks, 24 weeks), participant attendance at CR, and willingness to be randomized to treatment 2. Acceptability of the intervention will be assessed in qualitative focus groups and semi- structured interviews with children and young people, caregivers, and healthcare professionals _____ Previous primary outcome measures: The following primary outcome measures were assessed at baseline, and 12 and 24 weeks 1. Psychological wellbeing measured using the Strength and Difficulties Questionnaire (SDQ) 2. Quality of life measured using the Paediatric Quality of Life (PedsQol)	—

Measure

Time frame

Current primary outcome measures as of 06/07/2023: The following primary outcome measures will be assessed from baseline to end of follow-up: 1. Feasibility will be assessed using referral rates (baseline), recruitment and retention rates (baseline, 12 weeks, 24 weeks), participant attendance at CR, and willingness to be randomized to treatment 2. Acceptability of the intervention will be assessed in qualitative focus groups and semi- structured interviews with children and young people, caregivers, and healthcare professionals _____ Previous primary outcome measures: The following primary outcome measures were assessed at baseline, and 12 and 24 weeks 1. Psychological wellbeing measured using the Strength and Difficulties Questionnaire (SDQ) 2. Quality of life measured using the Paediatric Quality of Life (PedsQol)

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Secondary

Measure	Time frame
Current secondary outcome measures as of 06/07/2023: 1. Psychological wellbeing measured using the Strength and Difficulties Questionnaire (SDQ) at baseline, and 12 and 24 weeks 2. Quality of life measured using the Paediatric Quality of Life (PedsQol) at baseline, and 12 and 24 weeks 3. Aerobic capacity and endurance measured using the six-minute walk test (6MWT) at baseline, and 12 and 24 weeks 4. Physical activity levels measured using an accelerometer (Actigraph) at baseline, and 12 and 24 weeks 5. Metacognitive beliefs measured using the Metacognition Questionnaire-Adolescent (MCQ-A) at baseline, and 12 and 24 weeks 6. Quality of life measured using the Child Health Utility (CHU-9D) at baseline, and 12 and 24 weeks 7. Children’s use of primary, secondary, or community-based health and social care measured using a health and social service use questionnaire at baseline, and 12 and 24 weeks _____ Previous secondary outcome measures: 1. Aerobic capacity and endurance measured using the six-minute walk test (6MWT) at baseline, and 12 and 24 weeks 2. Physical activity levels measured using an accelerometer (Actigraph) at baseline, and 12 and 24 weeks 3. Metacognitive beliefs measured using the Metacognition Questionnaire-Adolescent (MCQ-A) at baseline, and 12 and 24 weeks 4. Quality of life measured using the Child Health Utility (CHU-9D) at baseline, and 12 and 24 weeks 5. Children’s use of primary, secondary, or community-based health and social care measured using a health and social service use questionnaire at baseline, and 12 and 24 weeks 6. Feasibility measured using referral rates at baseline, recruitment and retention rates at baseline, and 12 and 24 weeks, participant attendance at cardiac rehabilitation at 12 and 24 weeks and willingness to be randomized to treatment at baseline	—

Measure

Time frame

Current secondary outcome measures as of 06/07/2023: 1. Psychological wellbeing measured using the Strength and Difficulties Questionnaire (SDQ) at baseline, and 12 and 24 weeks 2. Quality of life measured using the Paediatric Quality of Life (PedsQol) at baseline, and 12 and 24 weeks 3. Aerobic capacity and endurance measured using the six-minute walk test (6MWT) at baseline, and 12 and 24 weeks 4. Physical activity levels measured using an accelerometer (Actigraph) at baseline, and 12 and 24 weeks 5. Metacognitive beliefs measured using the Metacognition Questionnaire-Adolescent (MCQ-A) at baseline, and 12 and 24 weeks 6. Quality of life measured using the Child Health Utility (CHU-9D) at baseline, and 12 and 24 weeks 7. Children’s use of primary, secondary, or community-based health and social care measured using a health and social service use questionnaire at baseline, and 12 and 24 weeks _____ Previous secondary outcome measures: 1. Aerobic capacity and endurance measured using the six-minute walk test (6MWT) at baseline, and 12 and 24 weeks 2. Physical activity levels measured using an accelerometer (Actigraph) at baseline, and 12 and 24 weeks 3. Metacognitive beliefs measured using the Metacognition Questionnaire-Adolescent (MCQ-A) at baseline, and 12 and 24 weeks 4. Quality of life measured using the Child Health Utility (CHU-9D) at baseline, and 12 and 24 weeks 5. Children’s use of primary, secondary, or community-based health and social care measured using a health and social service use questionnaire at baseline, and 12 and 24 weeks 6. Feasibility measured using referral rates at baseline, recruitment and retention rates at baseline, and 12 and 24 weeks, participant attendance at cardiac rehabilitation at 12 and 24 weeks and willingness to be randomized to treatment at baseline

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Countries

United Kingdom

Contacts

Public ContactLora Capobianco

lora.capobianco@gmmh.nhs.uk+44 (0)1612710724

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 7, 2026