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  • 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

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Cardiovascular medicine
Protocol
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
  1. Lora Capobianco1,
  2. Mark Hann2,
  3. Emma McManus3,
  4. Sarah Peters4,
  5. Patrick Joseph Doherty5,
  6. Giovanna Ciotti6,
  7. Joanne Murray7,
  8. Adrian Wells1,8,9
  1. 1Research and Innovation, Greater Manchester Mental Health NHS Foundation Trust, Manchester, UK
  2. 2NIHR School for Primary Care Research, Centre for Primary Care and Health Services Research, School of Health Sciences, University of Manchester, Manchester, UK
  3. 3Health 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
  4. 4Manchester Centre for Health Psychology, School of Health Sciences, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester, UK
  5. 5Health Science, University of York, York, UK
  6. 6Department of Pedeatric Cardiology, Manchester University NHS Foundation Trust, Manchester, UK
  7. 7Shrewsbury and Telford Hospital NHS Trust, Shrewsbury, UK
  8. 8Division of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK
  9. 9Greater Manchester Mental Health NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK
  1. Correspondence to Dr Lora Capobianco; Lora.Capobianco{at}gmmh.nhs.uk

Abstract

Background Congenital heart conditions are among the most common non-communicable diseases in children and young people (CYP), affecting 13.9 million 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.

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.

Method and analysis 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 11–16 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’s 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.

Ethics and dissemination 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.

Trial registration number ISRCTN50031147; NCT05968521.

  • MENTAL HEALTH
  • Paediatric cardiology
  • REHABILITATION MEDICINE
https://creativecommons.org/licenses/by/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

https://doi.org/10.1136/bmjopen-2023-077958

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    Footnotes

    • Contributors LC is the chief investigator and conceived the study, designed, and developed the initial trial protocol, developed the trial intervention, and contributed to the first and subsequent drafts of the manuscript. AW is the co-chief investigator and contributed to the study conception, designed, and developed the initial trial protocol, developed the trial intervention, and contributed to the first and subsequent drafts of the manuscript. AW provided translational guidance in applying the metacognitive model in CR. MH contributed to the study design, statistical analysis and sample size and wrote the quantitative evaluation section of the manuscript. EM developed the health economics components of the protocol and wrote these sections of the manuscript. GC contributed to the development of the trial recruitment strategy. PJD contributed to study design. JM contributed to adverse event reporting. SP developed the qualitative components of the protocol and wrote these sections of the manuscript. All authors edited the manuscript and read and approved the final version.

    • Funding The study is funded by the National Institute for Health Research (NIHR) under its Research for Patient Benefit Grant (Grant Reference Number: NIHR203634) and NIHR Manchester Biomedical Research Centre (Grant Reference Number: NIHR203308). The views expressed are those of the author(s) and not necessarily those of the NIHR or Department of Health and Social Care.

    • Disclaimer The views expressed are those of the author(s) and not necessarily those of the NIHR or Department of Health.

    • Competing interests AW is the creator of Metacognitive Therapy and codirector of the MCT Institute.

    • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

    • Provenance and peer review Not commissioned; externally peer reviewed.