Abstract

Background: People with rheumatoid arthritis experience foot and lower limb pain due to active synovitis, resulting in impaired lower limb function. Earlier intervention may help with prevention of functional decline. The aims of this research were to develop and evaluate a new gait rehabilitation intervention for people with early rheumatoid arthritis, evaluate its feasibility, and to test whether or not gait rehabilitation plus usual care is more clinically and cost-effective than usual care alone. Design and methods: We undertook a single-arm, repeated measures, pre- and post-intervention, mixed methods feasibility study with embedded qualitative components. We planned to undertake a pragmatic, two-arm, multi-centre, superiority randomised controlled trial, with health economic evaluation, process evaluation, and internal pilot. Setting and participants: Participants with early rheumatoid arthritis (<2 years post-diagnosis) were identified from early arthritis and rheumatology outpatient clinics and referred for intervention in either podiatry or physiotherapy clinics. Intervention(s): Participants were randomised to a gait rehabilitation programme (GREAT Strides) involving a 6-task gait circuit. Sessions were underpinned by motivational interviewing to facilitate behaviour change, supported by trained physiotherapists or podiatrists for a minimum of two sessions. Both groups received their normal usual care from the rheumatology multidisciplinary team. Main outcome measures: Outcome measures for the feasibility study were intervention acceptability, adherence using the Exercise Adherence Rating Scale (EARS) and fidelity using the Motivational Interviewing Treatment Integrity Scale (MITI). The main outcome measure for the internal pilot/RCT was the Foot Function Index disability subscale. Outcomes were measured at baseline, 3-months, 6-months and 12-months. Other outcomes: intervention acceptability questionnaire (IAQ), EARS, exercise treatment beliefs via the Theory of Planned Behaviour Questionnaire, intervention fidelity (MITI), health-related quality of life (EQ5D-5L). Results: Thirty-five participants were recruited for feasibility and 23 (65.7%) completed 12-week follow-up. Intervention acceptability was excellent; 21/23 were confident that it could help and would recommend it; 22/23 indicated it made sense to them. Adherence was good, with a median [IQR] EARS score of 17/24 [12.5–22.5]. Twelve participants’ and 9 therapists’ interviews confirmed intervention acceptability, identified perceptions of benefit, but highlighted some barriers to completion. MITI scores demonstrated good fidelity. The trial did not progress from internal pilot to full main trial as a result of low recruitment and high attrition, after fifty-three participants were recruited from nine sites over 12-months. Process evaluation confirmed good intervention acceptability and adherence, and fair fidelity. Evaluation of clinical and cost-effectiveness was not possible. Limitations: Significant delays were experienced with the impact of COVID-19, regulatory approvals, contracts, and site readiness, resulting in few sites opening in time and low recruitment capacity. Foot and/or ankle pain prevalence was lower than anticipated, resulting in a low potential participant pool and a low conversion rate from screening to enrolment. Conclusions: The GREAT Strides intervention was acceptable to people with early RA and intervention clinicians, safe, with good levels of adherence by participants, and fair intervention fidelity. The RCT stopped early following failure to meet recruitment targets. GREAT Strides is a promising intervention that could be adapted for future evaluations. A definitive trial of the GREAT Strides gait rehabilitation intervention still needs to be done. Study registration: ISRCTN (International Standard Randomised Controlled Trial Number) registry as ISRCTN14277030. Funding details: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme (15/165/04).