Congenital Heart DiseaseCardioActiveNCT05968521
Cardiac Rehabilitation for Young People
A study testing Cardiac Rehabilitation (CR): Experimental in people with Congenital Heart Disease and Cardiomyopathies, run by Greater Manchester Mental Health NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 16 years
- Conditions the study is for
- Congenital Heart Disease, Cardiomyopathies, Cardiac Arrythmias
- What is being tested?
- Cardiac Rehabilitation (CR): Experimental
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Mar 2024to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Fluent in English
- Consent to participate
- Diagnosed with at least one of the following:
- Congenital heart disease (all subtypes)
- Cardiomyopathy
- Cardiac arrhythmia
Show all 9Show fewer
- Heart failure
- Post-cerebrovascular event
- Post-heart valve repair/replacement
Who cannot join
- Significant risk or safeguarding concerns (i.e., suicidal ideation)
- Head injury/organic impairment
- Significant social and/or communication difficulties
- Those with a formal diagnosis or under assessment for any above exclusion criteria will be excluded.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Manchester University NHS Foundation Trust
Manchester, M13 9WL
Lora Capobianco, PhD, 01612710724, lora.capobianco@gmmh.nhs.uk
Lora Capobianco, PhD
About this study
Official title: Cardiac Rehabilitation for Young People: A Single-Blind Randomised Acceptability and Feasibility Study of an Integrated Physical and Mental Health Approach
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).
Read more
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
- Being tested
- Cardiac Rehabilitation (CR): Experimental, Treatment as usual: Control
- Keywords
- Cardiac Rehabilitation, Metacognitive Therapy, Mental health, Feasibility, Congenital Heart Disease
- Medical subject headings
- Heart Defects, Congenital, Cardiomyopathies, Heart Failure, Heart Valve Diseases, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Rehabilitation (CR): ExperimentalBehavioural
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.
Treatment as usual: ControlBehavioural
Treatment as usual will include routine clinical outpatient management.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Cardiac Rehabilitation (CR): Experimental |
| Treatment as usual (Control) | Active comparator | Participants allocated to the control group will receive treatment as usual. Receives: Behavioral: Treatment as usual: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: 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).
Measured: 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.
Measured: Date of Baseline Assessment to end of follow-up (24 week follow up)
Secondary outcomes (9)
Strength and Difficulties Questionnaire (SDQ)
The SDQ measures psychological wellbeing across five subscales: emotion, hyperactivity, conduct, peer relations and pro-social behaviour. The SDQ can be completed by CYP and caregivers.
Score for the subscales range from 0-10, with a total difficulties score (0-40) generated by summing together the scores from all subscales except the pro-social subscale. Higher scores on the pro-social scale reflect strengths whereas higher scores across other subscales reflect difficulties.
Measured: Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up)
Paediatric Quality of Life (PedsQol)
The PedsQol is a 23 item measures of health related quality of life, and includes four subscales: physical, emotional, social and school functioning. The questionnaire is commonly used in paediatric cardiology. The PedsQol will be completed by CYP.
The items are scores from 0 (Never) to 4 (Almost always). Total scores range from 0-100, with higher scores indicating better quality of life.
Measured: Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up)
Six minute walk test (6MWT)
The 6MWT is used to assess aerobic capacity and endurance. Performance on the 6MWT has been predictive of morbidity and mortality whereby poorer performance is associated with increased mortality.
Measured: Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up)
Incremental Shuttle Walk Test (ISWT)
The ISWT is used to measure maximal exercise capacity. The ISWT is a 12-level test (1 min at each level), whereby participants walk up and down a 10, course with increasing accelearion of 0.17 m/s up to a maximum speed of 2.37 m/s. Walking speed is dicated by an audio signal. The test ends when the subject has a heart rate greater than 85% of their predicted maximum, is limited by dyspnoea or when the participant is unable to maintain the required speed and doe snot complete a shuttle for second consecutive time. The distance covered from the number of shuttles will be calculated.
Measured: Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up)
Physical Activity Monitoring
Participants will wear an accelerometer (Actigraph) for 5 days to monitor physical activity levels at each assessment.
Measured: Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up)
Metacognition Questionnaire-Adolescent (MCQ-A)
The MCQ-A assesses metacognitive beliefs (beliefs about thinking) across five subscales (uncontrollability of worry, need to control thoughts, cognitive self-consciousness, positive beliefs about worry, and cognitive confidence). The measure contains 30 items and is scored on a likert scale from 1 (do not agree) to 4 (agree very much). Total scores range from 30-120 and 6 to 30 for each subscale. Greater scores indicate greater maladaptive metacognitive beliefs.
The measure and will be completed by CYP.
Measured: Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up)
Child Health Utility-9D (CHU-9D)
The CHU-9D measures quality of life using nine dimensions (worried, sad, pain, tired, annoyed, schoolwork/homework, sleep, daily routine, and ability to join in activities). Each item has 5 levels ranging from no problems to inability to do the item. Responses will be used to generate utility values in the health economic evaluation. The CHU-9D will be completed by CYP.
Measured: Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up)
Health and Social Care Service-Use Questionnaire
The questionnaire will include questions about whether the child has used any primary, secondary, or community-based health and social care and how often they used the service in the last 16 weeks (baseline study visit) or since the last assessment (follow-up study visits). The questionnaire will be developed from existing child relevant service use questionnaires held by the co-applicants and through discussion with the patient and public involvement representative, parent advisory group and clinical members of the study team. This will be completed by parents/primary caregivers. The responses given and the patient feedback will be used to further refine the health-resource use questionnaire ahead of the definitive study.
Measured: Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up)
Demographics Questionnaire
The demographics questionnaire will collect variables such as participants age, sex, weight, height, BMI, type of heart problem, comorbid mental and physical illnesses, ethnicity, medication, socioeconomic status, parental occupational status. This will be completed by the parents/primary caregivers.
Measured: Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start4 Mar 2024
- Primary completion31 Aug 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Greater Manchester Mental Health NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, University of Manchester, University of York
- Responsible party
- Principal investigator, Lora Capobianco, Greater Manchester Mental Health NHS Foundation Trust
- Investigators
- Lora Capobianco, PhD, Principal investigator, Greater Manchester Mental Health Foundation TrustAdrian Wells, PhD, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05968521
- Sponsor's protocol ID
- X638s
- Acronym
- CardioActive
- Status last verified
- Mar 2024
- First submitted
- 9 May 2023
- Last updated
- 7 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38401897
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Rehabilitation for Young People: A Single-Blind Randomised Acceptability and Feasibility Study of an Integrated Physical and Mental Health Approach
- ClinicalTrials.gov ID
- NCT05968521
- Acronym / sponsor ID
- CardioActive / X638s
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Greater Manchester Mental Health NHS Foundation TrustUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, University of Manchester, University of York
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cardiac Rehabilitation (Intervention) | Experimental | Behavioral: Cardiac Rehabilitation (CR): ExperimentalParticipants allocated to the intervention group will receive a cardiac rehabilitation (CR) programme which will involve education, exercise, and a psychological component. |
| Treatment as usual (Control) | Active comparator | Behavioral: Treatment as usual: ControlParticipants allocated to the control group will receive treatment as usual. |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Fluent in English
- Consent to participate
- Diagnosed with at least one of the following:
Key exclusion criteria (4 listed)
- Significant risk or safeguarding concerns (i.e., suicidal ideation)
- Head injury/organic impairment
- Significant social and/or communication difficulties
- Those with a formal diagnosis or under assessment for any above exclusion criteria will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac Rehabilitation (CR): ExperimentalCR 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. | Behavioural | Cardiac Rehabilitation (Intervention) |
| Treatment as usual: ControlTreatment as usual will include routine clinical outpatient management. | Behavioural | Treatment as usual (Control) |
Primary outcome
Recruitment Rate (Feasibility Outcome)
Time frame: Date of Baseline Assessment to end of follow-up (24 week follow up)
Feasibility will be assessed using recruitment rate (i.e., number of patients consented and randomized, number of patients declined the study).
Retention Rate (Feasibility Outcome)
Time frame: Date of Baseline Assessment to end of follow-up (24 week follow up)
Feasibility will be assessed using retention rates (i.e., number of patients withdrawn from the study, lost to follow up)
Intervention Attendance (Feasibility Outcome)
Time frame: Date of Baseline Assessment to end of follow-up (24 week follow up)
Feasibility will be assessed using participant attendance at intervention (i.e., number of sessions attended at the intervention).
Acceptability of the Intervention
Time frame: Date of Baseline Assessment to end of follow-up (24 week follow up)
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.
9 secondary outcomes
Strength and Difficulties Questionnaire (SDQ)
Time frame: Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up)
Paediatric Quality of Life (PedsQol)
Time frame: Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up)
Six minute walk test (6MWT)
Time frame: Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up)
Incremental Shuttle Walk Test (ISWT)
Time frame: Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up)
Physical Activity Monitoring
Time frame: Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up)
Metacognition Questionnaire-Adolescent (MCQ-A)
Time frame: Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up)
Child Health Utility-9D (CHU-9D)
Time frame: Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up)
Health and Social Care Service-Use Questionnaire
Time frame: Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up)
Demographics Questionnaire
Time frame: Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Derived from this study: PubMed 38401897Capobianco 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lora Capobianco, PhD principal investigator
Greater Manchester Mental Health Foundation Trust
Adrian Wells, PhD principal investigator
University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Rehabilitation (CR): Experimental in people with Congenital Heart Disease and Cardiomyopathies, run by Greater Manchester Mental Health NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lora Capobianco, PhD (01610046664, lora.capobianco@gmmh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (Feasibility Outcome) (time frame: Date of Baseline Assessment to end of follow-up (24 week follow up)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05968521, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.