Gait Rehabilitation for Early rheumatoid Arthritis Trial (GREAT): lessons learnt from a mixed-methods feasibility study and internal pilot trial
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 in...
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NIHR Journals Library
2025-03-01
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| Online Access: | https://doi.org/10.3310/XBDJ8546 |
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| author | Gordon J Hendry Lindsay Bearne Linda Fenocchi Nadine E Foster Sally Gates Emma Godfrey Samantha Hider Lisa Jolly Helen Mason Alex McConnachie Iain McInnes Aimie Patience Yeliz Prior Catherine Sackley Mandeep Sekhon Bethany Stanley Jason Vickers Jim Woodburn Martijn PM Steultjens |
| author_facet | Gordon J Hendry Lindsay Bearne Linda Fenocchi Nadine E Foster Sally Gates Emma Godfrey Samantha Hider Lisa Jolly Helen Mason Alex McConnachie Iain McInnes Aimie Patience Yeliz Prior Catherine Sackley Mandeep Sekhon Bethany Stanley Jason Vickers Jim Woodburn Martijn PM Steultjens |
| author_sort | Gordon J Hendry |
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| description | 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, multicentre, 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 (Gait Rehabilitation Early Arthritis Trial Strides) involving a six-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 and fidelity using the Motivational Interviewing Treatment Integrity Scale. The main outcome measure for the internal pilot/randomised controlled trial was the Foot Function Index disability subscale. Outcomes were measured at baseline, 3 months, 6 months and 12 months. Other outcomes: intervention acceptability questionnaire, Exercise Adherence Rating Scale, exercise treatment beliefs via the Theory of Planned Behaviour Questionnaire, intervention fidelity (Motivational Interviewing Treatment Integrity Scale), health-related quality of life (EuroQol-5 Dimensions, five-level score). 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 and 22/23 indicated it made sense to them. Adherence was good, with a median (interquartile range) Exercise Adherence Rating Scale score of 17/24 (12.5–22.5). Twelve participants’ and nine therapists’ interviews confirmed intervention acceptability, identified perceptions of benefit, but highlighted some barriers to completion. Motivational Interviewing Treatment Integrity Scale 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 53 participants were recruited from 9 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 coronavirus disease 2019, 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 Gait Rehabilitation Early Arthritis Trial Strides intervention was acceptable to people with early rheumatoid arthritis and intervention clinicians, safe, with good levels of adherence by participants, and fair intervention fidelity. The randomised controlled trial stopped early following failure to meet recruitment targets. Gait Rehabilitation Early Arthritis Trial Strides is a promising intervention that could be adapted for future evaluations. A definitive trial of the Gait Rehabilitation Early Arthritis Trial Strides gait rehabilitation intervention still needs to be done. Funding This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number 15/165/04.
Plain language summary Why did we do this research? Foot and ankle problems in people with rheumatoid arthritis can cause difficulty walking. It is unclear if starting exercise-based treatments earlier, close to diagnosis, would improve walking. We aimed to compare a new set of walking exercises, delivered by trained podiatrists or physiotherapists for home use, with usual care, which typically starts much later in the disease. What did we do? We developed a walking exercise programme with input from people with rheumatoid arthritis, National Health Service physiotherapists and podiatrists. Between June 2018 and March 2019, we recruited 35 participants with early rheumatoid arthritis, within 2 years of diagnosis, to test the programme and refine it before a trial. After finding the programme generally acceptable, we planned to compare it to usual care by randomly assigning participants to either the new intervention or their regular treatment. We monitored lower limb function and health outcomes over 6 months. What did we find? Both patients and clinicians found the programme acceptable and feasible. Clinicians were able to deliver it as expected after training. Unfortunately, coronavirus disease 2019 delayed the study, and post-coronavirus disease approval times were slower. We also faced challenges recruiting participants with both early rheumatoid arthritis and foot/ankle issues. As a result, the study ended early before we could evaluate the programme’s effectiveness. What does this mean for people with early rheumatoid arthritis? Early intervention with walking exercises can be successfully delivered by physiotherapists and podiatrists. Patients and clinicians found the programme acceptable and feasible. However, a full trial comparing this new exercise programme with usual care is still needed to determine its effectiveness. |
| format | Article |
| id | doaj-art-bc884b3473fa477caf21e15fc19f7b06 |
| institution | Kabale University |
| issn | 2046-4924 |
| language | English |
| publishDate | 2025-03-01 |
| publisher | NIHR Journals Library |
| record_format | Article |
| series | Health Technology Assessment |
| spelling | doaj-art-bc884b3473fa477caf21e15fc19f7b062025-08-20T03:41:04ZengNIHR Journals LibraryHealth Technology Assessment2046-49242025-03-0110.3310/XBDJ854615/165/04Gait Rehabilitation for Early rheumatoid Arthritis Trial (GREAT): lessons learnt from a mixed-methods feasibility study and internal pilot trialGordon J Hendry0Lindsay Bearne1Linda Fenocchi2Nadine E Foster3Sally Gates4Emma Godfrey5Samantha Hider6Lisa Jolly7Helen Mason8Alex McConnachie9Iain McInnes10Aimie Patience11Yeliz Prior12Catherine Sackley13Mandeep Sekhon14Bethany Stanley15Jason Vickers16Jim Woodburn17Martijn PM Steultjens18Research Centre for Health, Glasgow Caledonian University, Glasgow, UKPopulation Health Research Institute, St George’s, University of London, London, UKYunus Centre for Social Business and Health, Glasgow Caledonian University, Glasgow, UKSTARS Education and Research Alliance, Surgical Treatment and Rehabilitation Service (STARS), The University of Queensland and Metro North Health, Brisbane, AustraliaSchool of Health and Society, University of Salford, Salford, UKDepartment of Population Health Sciences, King’s College London, London, UKSchool of Medicine, Keele University, Newcastle, UKClinical Research and Development, NHS Greater Glasgow and Clyde, Glasgow, UKYunus Centre for Social Business and Health, Glasgow Caledonian University, Glasgow, UKRobertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UKInstitute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, UKResearch Centre for Health, Glasgow Caledonian University, Glasgow, UKSchool of Health and Society, University of Salford, Salford, UKDepartment of Population Health Sciences, King’s College London, London, UKPopulation Health Research Institute, St George’s, University of London, London, UKRobertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UKSchool of Health and Society, University of Salford, Salford, UKGriffith Centre of Biomedical and Rehabilitation Engineering, Menzies Health Institute Queensland, Griffith University, Gold Coast, AustraliaResearch Centre for Health, Glasgow Caledonian University, Glasgow, UKBackground 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, multicentre, 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 (Gait Rehabilitation Early Arthritis Trial Strides) involving a six-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 and fidelity using the Motivational Interviewing Treatment Integrity Scale. The main outcome measure for the internal pilot/randomised controlled trial was the Foot Function Index disability subscale. Outcomes were measured at baseline, 3 months, 6 months and 12 months. Other outcomes: intervention acceptability questionnaire, Exercise Adherence Rating Scale, exercise treatment beliefs via the Theory of Planned Behaviour Questionnaire, intervention fidelity (Motivational Interviewing Treatment Integrity Scale), health-related quality of life (EuroQol-5 Dimensions, five-level score). 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 and 22/23 indicated it made sense to them. Adherence was good, with a median (interquartile range) Exercise Adherence Rating Scale score of 17/24 (12.5–22.5). Twelve participants’ and nine therapists’ interviews confirmed intervention acceptability, identified perceptions of benefit, but highlighted some barriers to completion. Motivational Interviewing Treatment Integrity Scale 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 53 participants were recruited from 9 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 coronavirus disease 2019, 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 Gait Rehabilitation Early Arthritis Trial Strides intervention was acceptable to people with early rheumatoid arthritis and intervention clinicians, safe, with good levels of adherence by participants, and fair intervention fidelity. The randomised controlled trial stopped early following failure to meet recruitment targets. Gait Rehabilitation Early Arthritis Trial Strides is a promising intervention that could be adapted for future evaluations. A definitive trial of the Gait Rehabilitation Early Arthritis Trial Strides gait rehabilitation intervention still needs to be done. Funding This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number 15/165/04. Plain language summary Why did we do this research? Foot and ankle problems in people with rheumatoid arthritis can cause difficulty walking. It is unclear if starting exercise-based treatments earlier, close to diagnosis, would improve walking. We aimed to compare a new set of walking exercises, delivered by trained podiatrists or physiotherapists for home use, with usual care, which typically starts much later in the disease. What did we do? We developed a walking exercise programme with input from people with rheumatoid arthritis, National Health Service physiotherapists and podiatrists. Between June 2018 and March 2019, we recruited 35 participants with early rheumatoid arthritis, within 2 years of diagnosis, to test the programme and refine it before a trial. After finding the programme generally acceptable, we planned to compare it to usual care by randomly assigning participants to either the new intervention or their regular treatment. We monitored lower limb function and health outcomes over 6 months. What did we find? Both patients and clinicians found the programme acceptable and feasible. Clinicians were able to deliver it as expected after training. Unfortunately, coronavirus disease 2019 delayed the study, and post-coronavirus disease approval times were slower. We also faced challenges recruiting participants with both early rheumatoid arthritis and foot/ankle issues. As a result, the study ended early before we could evaluate the programme’s effectiveness. What does this mean for people with early rheumatoid arthritis? Early intervention with walking exercises can be successfully delivered by physiotherapists and podiatrists. Patients and clinicians found the programme acceptable and feasible. However, a full trial comparing this new exercise programme with usual care is still needed to determine its effectiveness.https://doi.org/10.3310/XBDJ8546pilot trialfeasibility studygait rehabilitationmotivational interviewingrheumatoid arthritisearly rheumatoid arthritisfootanklepainsynovitisrandomised controlled trial |
| spellingShingle | Gordon J Hendry Lindsay Bearne Linda Fenocchi Nadine E Foster Sally Gates Emma Godfrey Samantha Hider Lisa Jolly Helen Mason Alex McConnachie Iain McInnes Aimie Patience Yeliz Prior Catherine Sackley Mandeep Sekhon Bethany Stanley Jason Vickers Jim Woodburn Martijn PM Steultjens Gait Rehabilitation for Early rheumatoid Arthritis Trial (GREAT): lessons learnt from a mixed-methods feasibility study and internal pilot trial Health Technology Assessment pilot trial feasibility study gait rehabilitation motivational interviewing rheumatoid arthritis early rheumatoid arthritis foot ankle pain synovitis randomised controlled trial |
| title | Gait Rehabilitation for Early rheumatoid Arthritis Trial (GREAT): lessons learnt from a mixed-methods feasibility study and internal pilot trial |
| title_full | Gait Rehabilitation for Early rheumatoid Arthritis Trial (GREAT): lessons learnt from a mixed-methods feasibility study and internal pilot trial |
| title_fullStr | Gait Rehabilitation for Early rheumatoid Arthritis Trial (GREAT): lessons learnt from a mixed-methods feasibility study and internal pilot trial |
| title_full_unstemmed | Gait Rehabilitation for Early rheumatoid Arthritis Trial (GREAT): lessons learnt from a mixed-methods feasibility study and internal pilot trial |
| title_short | Gait Rehabilitation for Early rheumatoid Arthritis Trial (GREAT): lessons learnt from a mixed-methods feasibility study and internal pilot trial |
| title_sort | gait rehabilitation for early rheumatoid arthritis trial great lessons learnt from a mixed methods feasibility study and internal pilot trial |
| topic | pilot trial feasibility study gait rehabilitation motivational interviewing rheumatoid arthritis early rheumatoid arthritis foot ankle pain synovitis randomised controlled trial |
| url | https://doi.org/10.3310/XBDJ8546 |
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