Evidence map›Paper›PMID 38401897›Full record

ArticleBMJ open2024

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.

Lora Capobianco, Mark Hann, Emma McManus, Sarah Peters, Patrick Joseph Doherty, Giovanna Ciotti, Joanne Murray, Adrian Wells

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05968521 (Cardiac Rehabilitation for Young People), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.4field-weighted citation impact, top 41% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05968521 naunknown statusnot on this map

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

TypeinterventionalSponsorGreater Manchester Mental Health NHS Foundation TrustRan2024 to 2024Enrolled100ConditionsCongenital Heart Disease, Cardiomyopathies, Cardiac Arrythmias, Heart FailureArmsCardiac Rehabilitation (CR): Experimental, Treatment as usual: Control
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 5 institutions in 2 countries.

Lora CapobiancoResearch and Innovation, Greater Manchester Mental Health NHS Foundation Trust, Manchester, UK Lora.Capobianco@gmmh.nhs.uk.ORCID 0000-0001-6877-8650
Mark HannNIHR School for Primary Care Research, Centre for Primary Care and Health Services Research, School of Health Sciences, University of Manchester, Manchester, UK.
Emma McManusHealth 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.
Sarah PetersManchester Centre for Health Psychology, School of Health Sciences, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester, UK.
Patrick Joseph DohertyHealth Science, University of York, York, UK.ORCID 0000-0002-1887-0237
Giovanna CiottiDepartment of Pedeatric Cardiology, Manchester University NHS Foundation Trust, Manchester, UK.
Joanne MurrayShrewsbury and Telford Hospital NHS Trust, Shrewsbury, UK.
Adrian WellsResearch and Innovation, Greater Manchester Mental Health NHS Foundation Trust, Manchester, UK.
Manchester Academic Health Science Centre · GBGreater Manchester Mental Health NHS Foundation Trust · GBManchester University NHS Foundation Trust · GBShrewsbury and Telford Hospital NHS Trust · GBUniversity of York · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCongenital 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.

Indexed as

Cardiac RehabilitationAdolescentChildCost-Benefit AnalysisFeasibility StudiesHumansMental HealthQuality of LifeRandomized Controlled Trials as TopicSingle-Blind MethodMENTAL HEALTHPaediatric cardiologyREHABILITATION MEDICINE

Identifiers

PMID38401897
PMCPMC10895226
OpenAlexW4392131434

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.