Personalised Exercise-Rehabilitation FOR people with Multiple long-term conditions (PERFORM): protocol for a randomised feasibility trial.

INTRODUCTION: Personalised Exercise-Rehabilitation FOR people with Multiple long-term conditions (PERFORM) is a research programme that seeks to develop and evaluate a comprehensive exercise-based rehabilitation intervention designed for people with multimorbidity, the presence of multiple long-term conditions (MLTCs). This paper describes the protocol for a randomised trial to assess the feasibility and acceptability of the PERFORM intervention, study design and processes. METHODS AND ANALYSIS: A multicentre, parallel two-group randomised trial with individual 2:1 allocation to the PERFORM exercise-based intervention plus usual care (intervention) or usual care alone (control). The primary outcome of this feasibility trial will be to assess whether prespecified progression criteria (recruitment, retention, intervention adherence) are met to progress to the full randomised trial. The trial will be conducted across three UK sites and 60 people with MLTCs, defined as two or more LTCs, with at least one having evidence of the beneficial effect of exercise. The PERFORM intervention comprises an 8-week (twice a week for 6 weeks and once a week for 2 weeks) supervised rehabilitation programme of personalised exercise training and self-management education delivered by trained healthcare professionals followed by two maintenance sessions. Trial participants will be recruited over a 4.5-month period, and outcomes assessed at baseline (prerandomisation) and 3 months postrandomisation and include health-related quality of life, psychological well-being, symptom burden, frailty, exercise capacity, physical activity, sleep, cognition and serious adverse events. A mixed-methods process evaluation will assess acceptability, feasibility and fidelity of intervention delivery and feasibility of trial processes. An economic evaluation will assess the feasibility of data collection and estimate the costs of the PERFORM intervention. ETHICS AND DISSEMINATION: The trial has been given favourable opinion by the West Midlands, Edgbaston Research Ethics Service (Ref: 23/WM/0057). Participants will be asked to give full, written consent to take part by trained researchers. Findings will be disseminated via journals, presentations and targeted communications to clinicians, commissioners, service users and patients and the public. TRIAL REGISTRATION NUMBER: ISRCTN68786622. PROTOCOL VERSION: 2.0 (16 May 2023).

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.

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.

Home-based cardiac rehabilitation and physical activity in people with heart failure: a secondary analysis of the REACH-HF randomised controlled trials.

OBJECTIVES: To quantify the impact of a home-based cardiac rehabilitation intervention (Rehabilitation Enablement in Chronic Heart Failure (REACH-HF)) on objectively assessed physical activity (PA) of patients with heart failure (HF) and explore the extent by which patient characteristics are associated with a change in PA. DESIGN: Secondary analysis of randomised controlled trial data. SETTING: Five centres in the UK. PARTICIPANTS: 247 patients with HF (mean age 70.9±10.3 years; 28% women). INTERVENTIONS: REACH-HF versus usual care (control). PRIMARY AND SECONDARY OUTCOME MEASURES: PA was assessed over 7 days via GENEActiv triaxial accelerometer at baseline (pre-randomisation), post-intervention (4 months) and final follow-up (6-12 months). Using HF-specific intensity thresholds, intervention effects (REACH-HF vs control) on average min/day PA (inactivity, light PA and moderate-to-vigorous PA (MVPA)) over all days, week days and weekend days were examined using linear regression analysis. Multivariable regression was used to explore associations between baseline patient characteristics and change in PA. RESULTS: Although there was no difference between REACH-HF and control groups in 7-day PA levels post-intervention or at final follow-up, there was evidence of an increase in weekday MVPA (10.9 min/day, 95% CI: -2.94 to 24.69), light PA (26.9 min/day, 95% CI: -0.05 to 53.8) and decreased inactivity (-38.31 min/day, 95% CI: -72.1 to -4.5) in favour of REACH-HF. Baseline factors associated with an increase in PA from baseline to final follow-up were reduced MVPA, increased incremental shuttle walk test distance, increased Hospital Anxiety and Depression Scale anxiety score and living with a child >18 years (p<0.05). CONCLUSIONS: While participation in the REACH-HF home-based cardiac rehabilitation intervention did not increase overall weekly activity, patient's behaviour patterns appeared to change with increased weekday PA levels and reduced inactivity. Baseline PA levels were highly predictive of PA change. Future focus should be on robust behavioural changes, improving overall levels of objectively assessed PA of people with HF. TRIAL REGISTRATION NUMBERS: ISRCTN78539530 and ISRCTN86234930.

Discrete choice experiment to investigate preferences for psychological intervention in cardiac rehabilitation.

OBJECTIVE: Cardiac rehabilitation (CR) is offered to people who recently experienced a cardiac event, and often comprises of exercise, education and psychological care. This stated preference study aimed to investigate preferences for attributes of a psychological therapy intervention in CR. METHODS: A discrete choice experiment (DCE) was conducted and recruited a general population sample and a trial sample. DCE attributes included the modality (group or individual), healthcare professional providing care, information provided prior to therapy, location and the cost to the National Health Service (NHS). Participants were asked to choose between two hypothetical designs of therapy, with a separate opt-out included. A mixed logit model was used to analyse preferences. Cost to the NHS was used to estimate willingness to pay (WTP) for aspects of the intervention design. RESULTS: Three hundred and four participants completed the DCE (general public sample (n=262, mean age 47, 48% female) and trial sample (n=42, mean age 66, 45% female)). A preference for receiving psychological therapy was demonstrated by both samples (general population WTP £1081; 95% CI £957 to £1206). The general population appeared to favour individual therapy (WTP £213; 95% CI £160 to £266), delivered by a CR professional (WTP £48; 9% % CI £4 to £93) and with a lower cost (ß=-0.002; p<0.001). Participants preferred to avoid options where no information was received prior to starting therapy (WTP -£106; 95% CI -£153 to -£59). Results for the location attribute were variable and challenging to interpret. CONCLUSIONS: The study demonstrates a preference for psychological therapy as part of a programme of CR, as participants were more likely to opt-in to therapy. Results indicate that some aspects of the delivery which may be important to participants can be tailored to design a psychological therapy. Preference heterogeneity is an issue which may prevent a 'one-size-fits-all' approach to psychological therapy in CR.

Home-based rehabilitation for heart failure with reduced ejection fraction: mixed methods process evaluation of the REACH-HF multicentre randomised controlled trial.

OBJECTIVE: To identify and explore change processes explaining the effects of the Rehabilitation Enablement in Chronic Heart Failure (REACH-HF) intervention taking account of reach, amount of intervention received, delivery fidelity and patient and caregiver perspectives. DESIGN: Mixed methods process evaluation parallel to a randomised controlled trial using data from the intervention group (REACH-HF plus usual care). SETTING: Four centres in the UK (Birmingham, Cornwall, Gwent and York). PARTICIPANTS: People with heart failure with reduced ejection fraction (HFrEF) and their caregivers. METHODS: The REACH-HF intervention consisted of a self-help manual for patients with HFrEF and caregivers facilitated over 12 weeks by trained healthcare professionals. The process evaluation used multimodal mixed methods analysis. Data consisted of audio recorded intervention sessions; demographic data; intervention fidelity scores for intervention group participants (107 patients and 53 caregivers); qualitative interviews at 4 and 12 months with a sample of 19 patients and 17 caregivers. OUTCOME MEASURES: Quantitative data: intervention fidelity and number, frequency and duration of intervention sessions received. Qualitative data: experiences and perspectives of intervention participants and caregivers. RESULTS: Intervention session attendance with facilitators was high. Fidelity scores were indicative of adequate quality of REACH-HF intervention delivery, although indicating scope for improvement in several areas. Intervention effectiveness was contingent on matching the intervention implementation to the concerns, beliefs and goals of participants. Behaviour change was sustained when shared meaning was established. Respondents' comorbidities, socio-economic circumstances and existing networks of support also affected changes in health-related quality of life. CONCLUSIONS: By combining longitudinal mixed methods data, the essential ingredients of complex interventions can be better identified, interrogated and tested. This can maximise the clinical application of research findings and enhance the capacity of multidisciplinary and multisite teams to implement the intervention. TRIAL REGISTRATION NUMBER: ISRCTN25032672; Pre-results.

Feasibility study of early outpatient review and early cardiac rehabilitation after cardiac surgery: mixed-methods research design-a study protocol.

INTRODUCTION: Following cardiac surgery, patients currently attend an outpatient review 6 weeks after hospital discharge, where recovery is assessed and suitability to commence cardiac rehabilitation (CR) is determined. CR is then started from 8 weeks. Following a median sternotomy, cardiac surgery patients are required to refrain from upper body exercises, lifting of heavy objects and other strenuous activities for 12 weeks. A delay in starting CR can prolong the recovery process, increase dependence on family/carers and can cause frustration. However, current guidelines for activity and exercise after median sternotomy have been described as restrictive, anecdotal and increasingly at odds with modern clinical guidance for CR. This study aims to examine the feasibility of bringing forward outpatient review and starting CR earlier. METHODS AND ANALYSES: This is a multicentre, randomised controlled, open feasibility trial comparing postoperative outpatient review 6 weeks after hospital discharge, followed by CR commencement from 8 weeks (control arm) versus, postoperative outpatient review 3 weeks after hospital discharge, followed by commencement of CR from 4 weeks (intervention arm). The study aims to recruit 100 eligible patients, aged 18-80 years who have undergone elective or urgent cardiac surgery involving a full median sternotomy, over a 7-month period across two centres. Feasibility will be measured by consent, recruitment, retention rates and attendance at appointments and CR sessions. Qualitative interviews with trial participants and staff will explore issues around study processes and acceptability of the intervention and the findings integrated with the feasibility trial outcomes to inform the design of a future full-scale randomised controlled trial. ETHICS AND DISSEMINATION: Ethics approval was granted by East Midlands-Derby Research Ethics Committee on 10 January 2019. The findings will be presented at relevant conferences disseminated via peer-reviewed research publications, and to relevant stakeholders. TRIAL REGISTRATION NUMBER: ISRCTN80441309.

A randomised controlled trial of a facilitated home-based rehabilitation intervention in patients with heart failure with preserved ejection fraction and their caregivers: the REACH-HFpEF Pilot Study.

INTRODUCTION: Home-based cardiac rehabilitation may overcome suboptimal rates of participation. The overarching aim of this study was to assess the feasibility and acceptability of the novel Rehabilitation EnAblement in CHronic Hear Failure (REACH-HF) rehabilitation intervention for patients with heart failure with preserved ejection fraction (HFpEF) and their caregivers. METHODS AND RESULTS: Patients were randomised 1:1 to REACH-HF intervention plus usual care (intervention group) or usual care alone (control group). REACH-HF is a home-based comprehensive self-management rehabilitation programme that comprises patient and carer manuals with supplementary tools, delivered by trained healthcare facilitators over a 12 week period. Patient outcomes were collected by blinded assessors at baseline, 3 months and 6 months postrandomisation and included health-related quality of life (primary) and psychological well-being, exercise capacity, physical activity and HF-related hospitalisation (secondary). Outcomes were also collected in caregivers.We enrolled 50 symptomatic patients with HF from Tayside, Scotland with a left ventricular ejection fraction ≥45% (mean age 73.9 years, 54% female, 100% white British) and 21 caregivers. Study retention (90%) and intervention uptake (92%) were excellent. At 6 months, data from 45 patients showed a potential direction of effect in favour of the intervention group, including the primary outcome of Minnesota Living with Heart Failure Questionnaire total score (between-group mean difference -11.5, 95% CI -22.8 to 0.3). A total of 11 (4 intervention, 7 control) patients experienced a hospital admission over the 6 months of follow-up with 4 (control patients) of these admissions being HF-related. Improvements were seen in a number intervention caregivers' mental health and burden compared with control. CONCLUSIONS: Our findings support the feasibility and rationale for delivering the REACH-HF facilitated home-based rehabilitation intervention for patients with HFpEF and their caregivers and progression to a full multicentre randomised clinical trial to test its clinical effectiveness and cost-effectiveness. TRIAL REGISTRATION NUMBER: ISRCTN78539530.

Investigation of growth, development, and factors associated with injury in elite schoolboy footballers: prospective study.

OBJECTIVE: To investigate the differences between skeletal and chronological age and to assess the role of maturity status, anthropometric data, and football related variables in explaining injury statistics in elite schoolboy footballers. DESIGN: Prospective study of injuries in schoolboy footballers according to skeletal age. SETTING: Premier league football club in England. PARTICIPANTS: 292 schoolboy players (age 9-16) registered at the club INTERVENTIONS: Annual x ray film of hand or wrist. MAIN OUTCOME MEASURES: Data on injury 2001-7. Skeletal age determined with the Fels method. Skeletal age of more than one year above chronological age was classified as an early maturer, within one year as a normal maturer, and more than one year below normal as a late maturer. Injury and hours of training and rates of exposure to match play. RESULTS: Over six years 476 injuries were reported. The mean chronological age (11.74 (SD 2.35) years) and skeletal age defined by x ray picture (12.08 (SD 3.14) years) showed a significant mean difference of -0.344 (95% confidence interval -0.490 to -0.198; t=-4.64, df=280). Analysis of covariance showed that injury incidents did not differ significantly with maturity status after adjusting for training time, playing time, height, and position played (F=0.3(2,160), P=0.73). General log linear analysis with a Poisson model showed that difference in maturity, playing hours, and training hours collectively explained 48% of the variance in injury incidents. Injury exposure rates differed considerably, with 1.44/1000 hours for training and 10.5/1000 hours for match play. CONCLUSION: Maturity, defined by the difference between chronological age and skeletal age, plus training and playing hours together predict injury in schoolboy footballers. Injury exposure rates were higher for match play than training, which could have implications for targeting preventative interventions by academy staff. The use of skeletal age measurements to establish accurate "windows of opportunity" for training is more appropriate than the commonly used chronological age. Caution is needed when interpreting differences in injury occurrence as the factors that contribute are often complex.