{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,14]],"date-time":"2025-12-14T19:42:35Z","timestamp":1765741355024,"version":"3.48.0"},"reference-count":69,"publisher":"BMJ","issue":"2","license":[{"start":{"date-parts":[[2024,2,23]],"date-time":"2024-02-23T00:00:00Z","timestamp":1708646400000},"content-version":"unspecified","delay-in-days":22,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100009128","name":"Research for Patient Benefit Programme","doi-asserted-by":"publisher","award":["NIHR203634"],"award-info":[{"award-number":["NIHR203634"]}],"id":[{"id":"10.13039\/501100009128","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2023,12,14]]},"published-print":{"date-parts":[[2024,2]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Congenital heart conditions are among the most common non-communicable diseases in children and young people (CYP), affecting 13.9\u2009million CYP globally. While survival rates are increasing, support for young people adjusting to life with a heart condition is lacking. Furthermore, one in three CYP with heart conditions also experiences anxiety, depression or adjustment disorder, for which little support is offered. While adults are offered cardiac rehabilitation (CR) to support their mental and physical health, this is not offered for CYP.<\/jats:p>\n                    <jats:p>One way to overcome this is to evaluate a CR programme comprising exercise with mental health support (CardioActive; CA) for CYP with heart conditions. The exercise and mental health components are informed by the metacognitive model, which has been shown to be effective in treating anxiety and depression in CYP and associated with improving psychological outcomes in adult CR.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Method and analysis<\/jats:title>\n                    <jats:p>The study is a single-blind parallel randomised feasibility trial comparing a CR programme (CA) plus usual care against usual care alone with 100 CYP (50 per arm) aged 11\u201316 diagnosed with a heart condition. CA will include six group exercise, lifestyle and mental health modules. 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. Primary outcomes are feasibility and acceptability (ie, referral rates, recruitment and retention rates, attendance at the intervention, rate of return and level of completion of follow-up data). Coprimary symptom outcomes (Strength and Difficulties Questionnaire and Paediatric Quality of Life) and a range of secondary outcomes will be administered at each time point. A nested qualitative study will investigate CYP, parents and healthcare staff views of CR and its components, and staff\u2019s experience of delivering CA. Preliminary health economic data will be collected to inform future cost-effectiveness analyses. Descriptive data on study processes and clinical outcomes will be reported. Data analysis will follow intention to treat. Qualitative data will be analysed using thematic analysis and the theoretical framework of acceptability.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>Ethical approval was granted on 14 February 2023 by the Greater Manchester East Research Ethics Committee (22\/NW\/0367). The results will be disseminated through peer-reviewed journals, conference presentations and local dissemination.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"isrctn\" xlink:href=\"ISRCTN50031147\">ISRCTN50031147<\/jats:ext-link>\n                      ;\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT05968521\">NCT05968521<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2023-077958","type":"journal-article","created":{"date-parts":[[2024,2,24]],"date-time":"2024-02-24T05:05:17Z","timestamp":1708751117000},"page":"e077958","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":1,"title":["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\u201316 years with heart conditions"],"prefix":"10.1136","volume":"14","clinical-trial-number":[{"clinical-trial-number":"isrctn50031147","registry":"10.18810\/isrctn"},{"clinical-trial-number":"nct05968521","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct05968521","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"isrctn50031147","registry":"10.18810\/isrctn"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6877-8650","authenticated-orcid":false,"given":"Lora","family":"Capobianco","sequence":"first","affiliation":[{"name":"Research and Innovation, Greater Manchester Mental Health NHS Foundation Trust, Manchester, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mark","family":"Hann","sequence":"additional","affiliation":[{"name":"NIHR School for Primary Care Research, Centre for Primary Care and Health Services Research, School of Health Sciences, University of Manchester, Manchester, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emma","family":"McManus","sequence":"additional","affiliation":[{"name":"Health Organisation, Policy and Economics, Division of Population Health, Health Services Research and Primary Care, School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sarah","family":"Peters","sequence":"additional","affiliation":[{"name":"Manchester Centre for Health Psychology, School of Health Sciences, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1887-0237","authenticated-orcid":false,"given":"Patrick Joseph","family":"Doherty","sequence":"additional","affiliation":[{"name":"Health Science, University of York, York, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Giovanna","family":"Ciotti","sequence":"additional","affiliation":[{"name":"Department of Pedeatric Cardiology, Manchester University NHS Foundation Trust, Manchester, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joanne","family":"Murray","sequence":"additional","affiliation":[{"name":"Shrewsbury and Telford Hospital NHS Trust, Shrewsbury, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adrian","family":"Wells","sequence":"additional","affiliation":[{"name":"Research and Innovation, Greater Manchester Mental Health NHS Foundation Trust, Manchester, UK"},{"name":"Division of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK"},{"name":"Greater Manchester Mental Health NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2024,2,24]]},"reference":[{"key":"2025121411383329000_14.2.e077958.1","unstructured":"NCD Child . 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