Cardiac rehabilitation for children and young people
| ISRCTN | ISRCTN50031147 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50031147 |
| IRAS number | 319134 |
| ClinicalTrials.gov number | NCT05968521 |
| Secondary identifying numbers | CPMS 54520, IRAS 319134 |
- Submission date
- 02/03/2023
- Registration date
- 13/04/2023
- Last edited
- 01/05/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
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. 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 of this study is to develop and test the feasibility and acceptability of a trial of a cardiac rehabilitation programme for CYP.
Who can participate?
CYP aged 11-16 years old who have been diagnosed with one of the following heart conditions: congenital heart disease (all subtypes), cardiomyopathy, cardiac arrhythmia, heart failure, post-cerebrovascular event or post-heart valve repair/replacement.
What does the study involve?
Participants will be randomised into one of two groups: CR or treatment as usual. CR will be delivered across 6 sessions lasting 90 minutes. All participants will complete questionnaires at baseline, 12 weeks (end of treatment), and 24 weeks (follow-up). A qualitative study will explore CYP and their parents’ experiences of CR and trial participation.
What are the possible benefits and risks of participating?
The information gathered as part of this study will help inform future care within cardiac services for CYP with heart problems, and will provide details to develop further research on physical and mental health interventions for CYP with heart problems. While the risks in taking part are minimal it is possible that engagement in the exercise and physical activity component of the intervention may cause anxiety for patients and/or caregivers of patients with a heart condition. However, it will be highlighted to patients and their caregivers that the exercise sessions have been reviewed by a physiotherapist with experience working with patients with heart conditions and a child cardiologist who has deemed the exercise safe for CYP to engage in. It is also acknowledged that answering questionnaires and/or talking about difficulties can cause distress for patients. However, the mental health component of the intervention is designed to aid the management of negative thoughts and feelings more effectively, and participants will be made aware that they can withdraw at any time without any detrimental effect on their healthcare.
Where is the study run from?
Greater Manchester Mental Health NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
September 2022 to August 2025
Who is funding the study?
National Institute for Health Research (NIHR) (UK) Research for Patient Benefit
Who is the main contact?
Dr Lora Capobianco, lora.capobianco@gmmh.nhs.uk
Contact information
Scientific
3rd Floor Rawnsley Building
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom
 ORCID ID |
0000-0001-6877-8650 |
|---|---|
| Phone | +44 (0)1612710724 |
| lora.capobianco@gmmh.nhs.uk |
Scientific
3rd Floor Rawnsley Building
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom
| ORCID ID |
0000-0001-7713-1592 |
|---|---|
| Phone | +44 (0)1612765399 |
| adrian.wells@manchester.ac.uk |
Public
3rd Floor Rawnsley Building
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom
| Phone | +44 (0)1612710724 |
|---|---|
| lora.capobianco@gmmh.nhs.uk |
Study information
| Study design | Single-blind randomized acceptability and feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital, Internet/virtual, Telephone |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Cardiac rehabilitation for young people: a single-blind randomised acceptability and feasibility study of an integrated physical and mental health approach |
| Study acronym | CardioActive |
| Study objectives | The study aim is to develop and test the feasibility and acceptability of a trial of a cardiac rehabilitation programme for children and young people |
| Ethics approval(s) | 1. Approved 14/02/2023, Greater Manchester East Research Ethics Committee (3rd Floor Barlow House, 4 Minshull Street, Manchester, M1 3DZ, United Kingdom; +44 (0)207 104 8290; gmeast.rec@hra.nhs.uk), ref: 22/NW/0367 2. Approved 23/01/2023, North West Greater Manchester East Ethics Committee (Ground Floor, Temple Quay House, 2 The Square, Bristol, BS1 2NT, UK; +44 (0)20 71048061; gmeast.rec@hra.nhs.uk), ref: 22/NW/0367 |
| Health condition(s) or problem(s) studied | Cardiovascular and mental health in children and young people |
| Intervention | 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 educational, lifestyle and mental health sessions. Cardiac rehabilitation will be delivered by a combination of cardiac nurses, physicians, or physiotherapists. Sessions will be delivered face-to-face in a hospital gym. Staff do not need to have a background in mental health in order to deliver the training. Staff delivering the intervention will receive two full-day workshops followed by a pilot delivery of the CR programme to a group of volunteer patients. A further workshop will be arranged subsequently to review any successes and challenges in the pilot delivery. Staff will receive ongoing supervision throughout the trial in the delivery of the intervention. |
| Intervention type | Other |
| Primary outcome measure | 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) |
| Secondary outcome measures | 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 |
| Overall study start date | 01/09/2022 |
| Completion date | 31/08/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 11 Years |
| Upper age limit | 16 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 100 (120 including the qualitative component); UK Sample Size: 100 |
| Key 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 |
| Key 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. |
| Date of first enrolment | 01/03/2024 |
| Date of final enrolment | 28/02/2025 |
Locations
Countries of recruitment
- United Kingdom
Study participating centre
Manchester
M13 9WL
United Kingdom
Sponsor information
Hospital/treatment centre
R&I Office
Harrop House
Bury New Road
Prestwich
Manchester
M265 3BL
England
United Kingdom
| Phone | +44 (0)1612710080 |
|---|---|
| researchoffice@gmmh.nhs.uk | |
| Website | https://www.gmmh.nhs.uk// |
"ROR" |
https://ror.org/05sb89p83 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/08/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Lora Capobianco, lora.capobianco@gmmh.nhs.uk. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 26/07/2023 | No | No | ||
| Protocol article | 24/02/2024 | 26/02/2024 | Yes | No |
Editorial Notes
01/05/2024: Ethics approval details added. The recruitment end date was changed from 31/05/2024 to 28/02/2025.
08/04/2024: ClinicalTrials.gov number added.
26/02/2024: Publication reference added.
13/11/2023: The recruitment end date has been changed from 16/10/2023 to 01/03/2024.
26/09/2023: The recruitment start date was changed from 01/09/2023 to 16/10/2023.
06/07/2023: The following changes have been made:
1. The primary outcome measures have been changed.
2. The secondary outcome measures have been changed.
3. The participant exclusion criteria have been changed.
05/06/2023: The recruitment start date was changed from 01/06/2023 to 01/09/2023.
26/05/2023: The exclusion criteria were changed.
02/03/2023: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
