Objectives The Stretching And strengthening for Rheumatoid Arthritis of the Hand (SARAH) randomised controlled trial evaluated the effectiveness of a hand exercise programme and demonstrated it was clinically effective and cost-effective at 12 months. The aim of this extended follow-up was to evaluate the effects of the SARAH programme beyond 12 months.
Methods Using postal questionnaires, we collected the Michigan Hand Questionnaire hand function (primary outcome), activities of daily living and work subscales, pain troublesomeness, self-efficacy and health-related quality of life. All participants were asked how often they performed hand exercises for their rheumatoid arthritis. Mean difference in hand function scores were analysed by a linear model, adjusted for baseline score.
Results Two-thirds (n=328/490, 67%) of the original cohort provided data for the extended follow-up. The mean follow-up time was 26 months (range 19–40 months).
There was no difference in change in hand function scores between the two groups at extended follow-up (mean difference (95% CI) 1.52 (−1.71 to 4.76)). However, exercise group participants were still significantly improved compared with baseline (p=0.0014) unlike the best practice usual care group (p=0.1122). Self-reported performance of hand exercises had reduced substantially.
Conclusions Participants undertaking the SARAH exercise programme had improved hand function compared with baseline >2 years after randomisation. This was not the case for the control group. However, scores were no longer statistically different between the groups indicating the effect of the programme had diminished over time. This reduction in hand function compared with earlier follow-up points coincided with a reduction in self-reported performance of hand exercises. Further intervention to promote long-term adherence may be warranted.
Trial registration number ISRCTN89936343; Results.
- Rheumatoid Arthritis
- Hand therapy
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Collaborators Collaborating NHS sites (names as of time of participation): Basingstoke and North Hampshire Hospitals NHS Foundation Trust (North Hampshire Hospital), Derby Hospitals NHS Foundation Trust (Royal Derby Hospital), Dorset Primary Care Trust (Victoria Hospital), George Eliot Hospital NHS Trust (George Eliot Hospital), Heart of England NHS Foundation Trust (Solihull Hospital), Nuffield Orthopaedic Centre NHS Trust (Nuffield Orthopaedic Centre), Poole Hospital NHS Foundation Trust (Poole General Hospital), Portsmouth Hospitals NHS Trust (Queen Alexandra Hospital), Royal Bournemouth NHS Foundation Trust (Christchurch Hospital), Royal National Hospital for Rheumatic Diseases NHS Foundation Trust (Bath Royal National Hospital for Rheumatic Diseases), South Warwickshire General Hospitals NHS Trust (Warwick Hospital and Stratford On Avon Hospital), Sussex Community NHS Trust (Bognor Regis War Memorial Hospital), Winchester and Eastleigh Healthcare Trust (Royal Hampshire County Hospital), Worcestershire Acute Hospitals NHS Trust (Worcestershire Royal Hospital; Alexandra Hospital, Redditch; Kidderminster Hospital and Treatment Centre), Wrightington, Wigan and Leigh NHS Foundation Trust (Wrightington Hospital), University Hospitals Coventry & Warwickshire (University Hospital (Walsgrave site) and Rugby St Cross Hospital), University Hospitals of Leicester NHS Trust (Leicester Royal Infirmary and Leicester General Hospital). SARAH Trial team: Chief investigator: SEL. Coinvestigators: Dr J Adams, Prof MR Underwood, CMcC, Dr J Lord, Prof A Rahman. Trial lead: MW. Trial coordination/administration: SD, S Lowe, A Campbell, L Rattigan. Research fellows/associates: PH, EW, V Nichols. Trial statistician: CMcC. Health economists: Dr J Lord, C Crossan, Dr M Dritsaki, Dr M Glover. Research Clinicians (recruitment and data collection): Olivia Neely, Catherine Gibson, Karen Hotchkiss, Frances Chilton, Jessica Thrush, Catherine Minns-Lowe, Ann Birch, Linda Webber, Nicola Clague, Sue Kennedy, Kevin Spear, Sandi Derham, Dr Jenny Lewis, Sarah Bradley, Julie Cottrell, Paula White, Carole Frosdick, Jennifer Wilson, Nicola Bassett-Burr, Maggie Walsh. Intervention therapists (delivery of treatments): Lynda Myshrall, Jane Tooby, Cherry Steinberg, Mary Grant, Roslyn Handley, Fiona Jones, Clare Pheasant, Kate Hynes, Sue Kelly (UHCW NHS Trust); Joanne Newbold, Sally Thurgarland (George Eliot Hospital NHS Trust); Jane Dickenson, Lucy Mann (South Warwickshire Hospital NHS Trust); Alison Hinton, Rachel Chapman, Sunita Farmah, Collette James, Janice Wiltshire, Jane Simons (Worcester Acute Hospitals NHS Trust); Jane Martindale, Susan Hesketh, Alison Gerrard (Wrightington, Wigan & Leigh NHS Trust); Kirsty Bancroft, Corinna Cheng (Poole Hospital NHS Trust); Caroline Wood (Royal Bournemouth NHS Trust); Lisa Small, Karen Coales, Helen Ibbunson, Anne Bonsall (Bath Royal National Hospital for Rheumatic Diseases); Caroline Mountain, Jonathan Gibbons, Esther Mavurah, Hannah Susans (Portsmouth Hospitals NHS Trust); Nicola Spear, Becky Shaylor, Leon Ghulam (Basingstoke & North Hampshire Hospital NHS Trust); Sarah Wastell (Dorset NHS Trust); Christina MacLeod, Sapphire Patterson, Jane Vadher (Winchester & Eastleigh Healthcare NHS Trust); Karen Barker, Sue Gosling, Lizelle Sander-Danby, Jon Room, Aimee Fenn, Anne Richards, Pam Clarke, Gill Rowbotham, Nicky Nolan(Nuffield Orthopaedic Centre NHS Trust); Lorraine Kendall (Bognor Regis War Memorial Hospital); Claire Charnley (Solihull Hospital); Laura Richardson, Kate Wakefield (Leicester Royal Infirmary); Victoria Jansen, Liz Radbourne, Julie Tougher (Royal Derby Hospital).
Trial Steering Committee: Prof Alison Hammond (Chair), Dr Chris Deighton, Dr Chris McCarthy, SEL, MW, Mr John Wright (User representative). Data Monitoring Committee: Mr Ed Juszczak, Prof Paul Dieppe, Dr Helen Frost.
Contributors EW contributed to designing the trial, data collection, interpretation of the data, drafting and revising of the paper and final approval of the version to be published. CMcC contributed to data analysis and interpretation, drafting and revising the paper and final approval of the version to be published. PH contributed to design of the trial, data collection, interpretation of the data, revision of the paper and final approval of the version to be published. SD participated in trial administration, data collection, revision of the paper and final approval of the version to be published. MW participated in designing the trial, data collection and interpretation of the data, revision of the paper and final approval of the version to be published. SEL participated in conceptualising and designing the trial, data analysis and interpretation, drafting and revising of the paper and the final approval of the version to be published.
Funding The SARAH trial was funded by the National Institute of Health Research Health Technology Assessment Programme (NIHR HTA), project number 07/32/05. This project benefited from facilities funded through Birmingham Science City Translational Medicine Clinical Research and Infrastructure Trials Platform, with support from Advantage West Midlands (AWM). The preparation of this article was supported by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care Oxford at Oxford Health NHS Foundation Trust.
Disclaimer The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.
Competing interests None declared.
Ethics approval Oxford C Multicenter Research Ethics Committee (REC reference 08/H0606/4).
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement The data are available on request from the chief investigator (SEL).
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