Title: Cardiac Rehabilitation for Young People: A Single-Blind Randomised Acceptability and Feasibility Study of an Integrated Physical and Mental Health Approach
Funder: Department of Health and Social Care

Abstract: Research Question: Is a future large scale parallel randomised trial of cardiac rehabilitation (CR) for children and young people (CYP) with heart conditions acceptable and feasible? Background: Cardiovascular disease is amongst the most common non-communicable diseases, affecting 13.9 million CYP globally. Survival rates for CYP with heart conditions are rising, however support for adjusting to life with a heart condition is lacking, as such it is unsurprising that 1 in 3 CYP with heart conditions also suffer from anxiety, depression, or adjustment disorder. While adults are offered CR to support their mental and physical health, this is not offered for CYP. One way to overcome this is to develop and test a CR programme comprising exercise with mental health support (group CR) for CYP with heart conditions. Mental health support could be offered using Metacognitive Therapy (MCT), a psychological therapy shown to be effective in treating anxiety and depression in CYP and adults in mental health settings. MCT has been shown to be effective in treating anxiety and depression in adult CR and appears to reduce psychological deterioration. Exercise and MCT techniques might be delivered as part of the CR programme in paediatric cardiac care. Aim: Assess the acceptability and feasibility of delivering a CYP-CR programme under randomised trial conditions and over time. Objectives: Assess the variability and acceptability of primary and secondary outcome measures, collect data to inform a sample size calculation for a definitive trial, obtain preliminary economic data to inform the optimal way to evaluate cost-effectiveness and collect qualitative data on CYP, parents, and healthcare staff s views of CR and its components. Methods: 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. CR will include six group exercise and lifestyle modules and MCT sessions. Usual care consists of routine outpatient management. Participants will be assessed at three time points: baseline, 3-month (post-treatment) and 6-month follow up. Co-primary outcomes (strength and difficulties questionnaire and paediatric quality of life), and a range of secondary outcomes will be administered at each time point. The qualitative study will evaluate CYP, parents, and healthcare staff views of CR and its components, and staff s experience of delivering CR. Preliminary health economic data will be collected to inform future cost-effectiveness analyses. Timelines: The study will take 36 months: 8 months for study set up and development of CR modules, 18 months for recruitment, treatment delivery and follow up, and the remaining for analysis and dissemination. Impact and Dissemination: Study data will inform the design of a definitive trial by providing data for a power and sample size estimation, performance of measures, feasibility of recruitment and the acceptability of a trial/intervention. Researchers, patients, and clinicians will benefit as it offers preliminary information for a subsequent trial, and the potential for improved outcomes that can benefit service users and clinicians. Results will be disseminated via peer-reviewed journals, conferences and service user/voluntary sector organizations and networks.

Lay abstract: Background: 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. A talking based therapy called metacognitive therapy (MCT) has been shown to be effective in treating anxiety and depression in CYP and adults in mental health settings, and in treating anxiety and depression in adult CR. MCT techniques might be delivered as part of a CYP CR programme. Aims: 1) Develop a CR programme for CYP with heart problems, that includes six exercise and education classes plus psychological support lasting a total of 90 mins per session. 2) To see what CYP, parents and clinicians think of CR and see if it is achievable to deliver CR in children s cardiac services 3) To gather important information to know how to run a larger randomised controlled trial of CR in heart services for CYP (i.e. can we recruit families, will they complete the questionnaires). Design: We will ask CYP, caregivers and healthcare professionals about their experience of living with and managing heart problems, in developing the content and format of the CR programme. We will then conduct a randomized feasibility study. Patients will be randomly allocated to either: (1) usual care (i.e. no additional intervention); or (2) CR using exercise, education and MCT techniques. Participants will complete questionnaires at baseline, 3-month and 6-month follow up. Information about CYPs medical and mental health outcomes will be collected. Patient and public involvement (PPI): A PPI group will be formed and will include: (1) CYP with heart conditions; (2) caregivers of CYP with heart conditions; (3) healthcare staff working with CYP. The groups will advise and co-develop the study materials, recruitment strategy, aid in participant retention (i.e., creating newsletters) and participate in dissemination of study findings. Dissemination: The study will impact CYP, caregivers, researchers, clinicians, and the community. Findings will be publicized across a variety of outlets to ensure maximum outreach including conferences, peer-review, publications, social media, and workshops for parents, CYP and clinicians.

Research activity codes: 5.7 PHYSICAL;5.6 PSYCHOLOGICAL AND BEHAVIOURAL;6.7 PHYSICAL;6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: CARDIOVASCULAR