Population

Potential participants will be included if they meet the following inclusion and exclusion criteria: they have (1) a primary clinical diagnosis of stroke (assessed by referring clinician/general practitioner (GP) records), (2) they are at least 1 month (but no upper limit) since discharge from NHS physical rehabilitation services at randomisation, (3) they are able to walk independently indoors with or without mobility aids, but have self-reported difficulty with or require help on stairs, slopes or uneven surfaces, (4) a willingness to be randomised to either control or ReTrain and to attend the training venue, (5) have cognitive capacity and communication ability sufficient to participate in the study (assessed by recruiting team using standard tools).25

Criterion (3) has been selected pragmatically to maximise eligibility while ensuring participants have a mobility deficit that could be addressed by the intervention. Eligible people with aphasia will not be excluded.

Potential participants will be excluded if they are <18 years old, currently (or within 1 month of) receiving ARNI-based training or have contraindications to moderate-to-vigorous physical activity (adapted from American College of Sports Medicine (ACSM) guidelines)26 including:

• Acute or uncontrolled heart failure;

• Unstable or uncontrolled angina;

• Uncontrolled cardiac dysrhythmia causing symptoms or haemodynamic compromise;

• Symptomatic severe aortic stenosis;

• Current deep vein thrombosis, pulmonary embolus or pulmonary infarction;

• Acute myocarditis or pericarditis;

• Suspected or known dissecting aneurysm;

• Unstable/uncontrolled blood pressure;

• Systolic blood pressure >160;

• Diastolic blood pressure >100;

• Acute systemic infection;

• Uncontrolled diabetes.

Sample size

The target recruitment number is 48 participants (24 per group). This number is based on the recommendation of 30 complete data sets for pilot studies in order to estimate outcome variance27 and running the intervention three times (Exeter I and South Devon, then Exeter II, ie, 3×8 patients) to enable investigation of variations in context and other process variables. This recruited number also allows estimation of a predicted attrition rate of 20% with a precision of ±5% with 95% certainty.

Participant recruitment

Participants will be recruited and the programme delivered in two areas of Devon (Exeter and South Devon). These areas cover a population of 250 000 with at least 3000 stroke survivors who require the help of others in everyday activities.11 To maximise potential recruitment, several routes for recruitment will be used to reach both those who are just leaving rehabilitation services and those who have been discharged for some time:

1. Via clinicians in NHS primary care, hospital and community stroke services:

   • Early supported discharge teams;

   • Community rehabilitation teams;

   • Physiotherapy outpatients departments;

   • Those responsible for conducting the 6-month review recommended by the National Stroke Strategy;

   • GP surgeries via the local Clinical Research Network (CRN).

Clinicians will provide potential participants with an invitation letter and brief description of the study and, if they are interested, obtain permission to pass on their details to the study team. The clinician will ask the potential participant to complete a short form (or complete the form on their behalf), recording their contact details and consenting for these details to be passed to the research team.

• Direct (using contacts)

  • The CRN (formerly South West Stroke Research Network (SW SRN)) using hospital-based recruitment team, newsletters and targeted mailing;

  • Exeter Clinical Research Facility which maintains a database of health research-interested members of the public;

  • Letters, articles and posters will be used to provide brief details of the study and invite expressions of interest to contact the research team by telephone call, email or post.

• Promotion via local stroke support networks identified through national organisations such as the Stroke Association, Different Strokes and Connect, and via internet searches and in local media.

• Word of mouth, study flyers, adverts and information sheets.

We have discussed recruitment plans with two local community rehabilitation team leads and the CRN (who have checked three GP surgery's databases); from this we estimate a recruitment rate of 5–6 participants per month although this is one of the feasibility objectives being tested in this study. Our preliminary Devon-based studies recruited 2–4 participants per month, but only from the Exeter area, without formal network support, using fewer routes, and based on narrower inclusion criteria to the current proposal.

A potential issue in recruitment is the likelihood of attracting people who are already committed to exercise and not those who are currently inactive, who may be put off by the emphasis on the term ‘exercise’. Focus groups conducted previously by the research team, and our Service User Group (SUG), have suggested that promotion should emphasise the potential functional and quality of life benefits, and not promote it primarily as physical exercises. To this end, a member of the research team will brief and support the personnel involved in providing initial information about the study to potential participants, and where necessary spend time in contact with potential participants to help their understanding of the intervention and study. For those who are already committed to exercising, they will still be eligible providing they are no longer involved in a formal rehabilitation programme. Because of uncertainty in recruitment rates and patterns and the need to have eight people ready to start the training programme, some participants may have to wait several weeks until sufficient group members have been recruited. To help mitigate the potential problem of excluding those who do not live close to a venue, reasonable travel costs (eg, mileage claims, local bus and train journeys, and specialised wheelchair taxis) to and from the training venue will be offered to all participants.

Randomisation and group allocation

To ensure allocation concealment, participants will be allocated 1:1 to either intervention or control arms using a web-based randomisation service supported by the Peninsula Clinical Trials Unit (PenCTU). We will use minimisation procedures to ensure balance between groups on two variables: time since stroke (≤3 vs >3 months), since spontaneous recovery might be more likely among those whose stroke was relatively recent,28 and level of functional disability (modified Rankin Scale29 (mRS) score ≤2 vs >2), since this may limit the extent and nature of training possible for a participant. Once the remote randomisation service has registered and randomised the participant, allocation will be made known to the trial manager, who will not be involved in assessing patient outcomes. Following randomisation, the trial manager will contact participants to inform them of group allocation.

Blinding

Participants, personal trainers providing the intervention, and researchers conducting the process and economic evaluation cannot be blinded to allocation. However, outcomes will be assessed by an independent assessor blinded to group allocation. Participants, who have been informed of their allocation, will be reminded to hide their allocation from the assessor. Any incidents of unblinding will be recorded, and the assessor will be asked to record their guess of participant allocation after undertaking the assessments. Following recommended strategies to maintain and assess blinding,30 the outcomes assessor will not be based at the research centre.

Intervention

ReTrain is a specified intervention that is based on ARNI but also draws on poststroke exercise guidelines,9 our preliminary studies and stakeholder consultations; this combination makes it a novel intervention compared with other community exercise-based programmes. ReTrain aims to (1) enhance function through (A) task-related practice, (B) teaching adapted or compensatory strategies and (C) provide targeted strength training (cardiovascular physical fitness gains also occur through these activities); (2) develop self-management skills for ongoing rehabilitation; (3) personalise training using negotiated goals; and (4) instil a commitment to and habit of regular exercise for health improvement and longer term maintenance (once structured training programme has been completed). ReTrain focuses on functional mobility which includes safe and efficient walking in varied terrains, kerbs, cambers and in crowds, turning and moving quickly, climbing steps and stairs without rails, getting to and from the floor without furniture or other aids, and moving about without mobility aids or while carrying loads. Training will be based on an Intervention Delivery manual and led by personal trainers on the Register of Exercise Professionals (level 3 or above) who are ARNI-trained and accredited (and will be aware if there are stroke-related concerns that require referral) and they will have received additional training in the delivery of ReTrain. There will be a maximum ratio of one trainer to four stroke survivors. The use of personal trainers rather than clinicians is based on a principle of de-medicalising the rehabilitation process18 ,31 ,32 and received strong support from our SUG. It may also have cost-effectiveness benefits.14 ,33 ReTrain is predominantly based in a community centre with twice weekly, 90 min sessions over 3 months, comprising: (1) an introductory one-to-one session (as a home visit); (2) group classes with up to two trainers and eight clients (preserving the maximum ratio of one trainer to four participants); (3) a closing one-to-one session (as a home visit). This is followed by three drop-in sessions over the subsequent 3 months at the community centre. The final one-to-one session and monthly drop-in sessions address concerns raised by our preliminary study participants of the sudden cessation of support.23 A more thorough description of the intervention can be seen in figure 2. The ReTrain Trainer and Intervention Delivery manuals were designed using an overarching theoretical framework that enabled existing evidence-based components (from the physiology of exercise training, Behaviour Change Techniques34 and stroke rehabilitation guidelines) to be mapped together with the as yet unresearched ARNI principles and techniques. The theoretical framework is known as the Information-Motivation-Behavioural Skills model35 and enables intervention mapping to take place.36 This mapping process will be developed and refined as part of the feasibility work of this study and will specify the essential resources, activities and behaviours of trainers and clients that must be present in sessions and across the programme. Session checklists will capture the main content and indicate where flexibility is permitted (for individualisation of training) and allow evaluation of intervention fidelity.

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Figure 2

The ReTrain programme. (ARNI, Action for Rehabilitation from Neurological Injury; GP, general practitioner; TM, trial manager).

Control

All participants receive treatment as usual (which will be recorded for both groups) however, in addition, the control group will receive an advice booklet about exercise after stroke, based on a Stroke Association's publication.24 This offers a low-cost alternative to ReTrain that might be provided to stroke survivors, although it does not give advice on specific exercises. We believe offering an advice booklet to the control patients, will improve recruitment and retention.

Assessment and outcomes

Usual care

Participants in intervention and control arms may receive health and social care as part of their usual care, and these will be recorded using the Service Receipt Inventory.

Foreseen difficulties

(1) ‘Exercise’ as a term may be off-putting to some people. Our SUG and preliminary studies participants strongly advised that we emphasise the potential functional and quality of life benefits and not promote ReTrain as an exercise programme; however, it was agreed that community leisure centres were an acceptable venue. (2) Timing: some of those who give consent to take part may have to wait until the next ReTrain programme is ready to start. The wait will be minimised by running successive Exeter-based programmes alongside the South Devon programme and the study team will maintain brief but regular contact with those waiting. The feasibility and acceptability of this process, including the wait time and recruitment/retention issues more generally, are part of what is being tested in this pilot study. (3) Participant burden: particularly completion of the battery of measures and travel to intervention venue. These were deemed acceptable by most participants in our preliminary studies and this was affirmed during our SUG events when planning this proposal. Participant carers may experience some burden as they may need to support the participants by providing travel to and from the 23 training sessions at the community centre venue. The carer will also be asked to complete a questionnaire at two time points during the research. (4) Trainer availability: we worked with five trainers during our preliminary studies and there are currently more than 100 accredited ARNI trainers in the UK, indicating there would be capacity to deliver a future multicentre trial but more trainers might be needed if wider future implementation was indicated. Three local trainers have agreed to deliver the current study ReTrain programmes.

Service user involvement

Stroke survivors, their partners and carers have been consulted at all stages of the work leading to this proposal. In 5 SUG events and 14 research development meetings over 5 years our patient and public involvement (PPI) representatives have materially influenced decisions on the study population, promotion and recruitment, the nature of the ReTrain intervention and how its effectiveness should be assessed. One experienced PPI representative will be in the Trial Management Group (TMG), and another, who has experience of ARNI training, will be in the Study Advisory Group (SAG). The founder of ARNI, Dr Tom Balchin will also be part of the SAG. Our service users will also continue to contribute throughout this pilot study in terms of reviewing documentation for ethics approval, commenting on and proof reading reports and contributing to dissemination activities. They have, and will continue to be, supported in their work by the Peninsula's Collaboration for Leadership in Applied Health Research and Care (PenCLAHRC) PPI team, for example, by attending workshops on critical appraisal skills.

Data analysis

Given the feasibility objectives of this pilot study, the focus of data analysis will be descriptive. For both recruitment settings (Exeter and South Devon) participant flow will be summarised using the CONSORT flow diagram, reporting recruitment and attrition rates (both treatment and study drop-outs) with 95% CIs. The diagram will also reflect the number of recruitment letters sent, numbers consenting, number randomised, number undertaking intervention and number of completed outcomes alongside means and SDs regarding the number, length and frequency of sessions. All protocol deviations, along with reasons and number of missing items on questionnaires will be reported. Mean and SDs (or equivalent) for all clinical outcomes for both study arms will be reported at baseline, 6 and 9 months follow-up. For the trial process evaluation, we will use a thematic analysis for the qualitative interview data and use several of the quantitative measures (including demographic, medical and questionnaire data) to help identify and understand potential mediators and moderators of trial outcome. For the analysis of intervention fidelity, we will use the procedures we designed and tested in our preliminary studies for the video analysis combined with trainer interview data and the session checklists (that will be part of the Intervention Delivery manual). These data collection and analysis methods will be assessed for their potential to inform the process evaluation component of a definitive trial. In such a future trial, the health economics analysis will be a cost-utility analysis, using QALYs and secondary analyses will investigate the benefits of the intervention more broadly within the framework of a cost consequences approach, so offering the potential to weight different outcomes in a multicriteria decision analysis framework.51 In this pilot study, we will assess the relative benefits of calculating health-related quality of life using SF-6D developed from the SF-12 over the QALY calculated using EQ-5D-5L; explore the psychometric properties of the SF-12 and investigate whether it has greater ability to discriminate between the milder health states. We will assess costs associated with intervention delivery as well as assess the feasibility of collecting health and social service resource use through a Service Receipt Inventory. Any missing data in the Inventory will be recorded and we will check if any resource use categories are misunderstood by matching Inventory completion with medical records for a subgroup of participants. This will help us develop strategies to minimise missing data in a future definitive trial.

Study timeline

The timetable for the research can be seen in table 2: months 0–4 set up and trainer briefing; months 0–9 recruitment: including participant identification (0–9 months), screening (2–9 months), consent and baseline assessments (3–9 months); months 5–15 training programmes inclusive of 6 and 9 month follow-ups; month 18 complete the 9-month follow-ups; months 11–18 interviews; months 16–21 analysis and final reports. Trial management meetings and SUG meetings will be held on 10 occasions across the 21 months of the study.

Incentives and payments

Incentive payments will also be made to control and intervention group participants and paid on two occasions: £10 in vouchers at 6 months and £10 in vouchers at 9 months. These incentives are intended to maximise the chances of obtaining a full data set, including the views of any people who leave the intervention or control groups (but do not fully withdraw from the study) and this will assist the process evaluation. Participants have to remain in the study but do not have to complete all assessments in order to receive the vouchers.

The latest NHS Health Research Authority guidance on Payments and Incentives in Research (May 2014, Section 9.1) states that pro-rata payments based on the amount of time completed and/or the number of research procedures undertaken are legitimate. Our intention would be to disburse 50% of the incentive payment at the time of the postintervention (6 months) outcome assessment and the remainder at the time of the follow-up (9 month) assessment.

Governance and safety considerations

Drafts of the trial protocol have been reviewed by the Southwest Research Design Service and the Stroke Clinical Studies Group. The trial is registered with the ClinicalTrials.gov: trial number NCT02429180. The study sponsor is the University of Exeter.

Trial monitoring and management

Day-to-day running of the trial will be the responsibility of the trial manager. Standard operating procedures will be written for: (1) assessment processes and reporting; (2) data management; (3) adverse incidents monitoring, reporting and action; (4) study staff health and safety.

The core study team (CI, trial manager and assistant research fellow) will meet at least fortnightly during the study. TSC meetings will be held (if necessary by teleconference) on three occasions. The TSC will discuss recruitment, withdrawals, study progress, process evaluation and adverse events, and will advise on protocol amendments where necessary. The steering group will include academics with expertise in trial methodology, health economics, qualitative methods and process evaluation, clinicians with expertise in stroke and rehabilitation, and stroke survivors. Owing to the low risk of adverse events, an independent Data Monitoring and Safety Committee will not be appointed for this pilot study. Instead, we will appoint suitably qualified academics and clinicians to the TSC who will have responsibility for independently monitoring the safety and quality of the trial. A closed meeting prior to the TSC meetings will take place with the independent members of the TSC who will also be responsible for oversight of the safety of the trial and data integrity (thereby taking on the role of the Data Monitoring and Ethics Committee).

Our preliminary studies suggest that the trial does not pose any specific risks to individual participants nor does it raise any substantial ethical issues. Based on results from our development work ReTrain is a low-risk intervention. Participants will be informed of possible benefits and known risks of participation in the trial by means of a patient information leaflet and discussion with the research team. All participants will sign a consent form approved by the Ethics Committee. They will be consented to participating in the trial, being randomised and followed up, for accessing their medical records to review their primary and secondary care resource use, for video-recording of training sessions, participating in and being audio-recorded during interview and being contacted in the future about this and other research. Individuals who are not able or not willing to be randomised will not be recruited. Individuals will be sent an additional patient information leaflet relating to the interview study. Written consent will be obtained again immediately prior to the interview study, the video-recorded training sessions, and prior to medical notes review. This will be performed to allow the participants to fully consider their participation decisions and to confirm or change their original consenting decision.