Strengthening and stretching for rheumatoid arthritis of the hand (SARAH): design of a randomised controlled trial of a hand and upper limb exercise intervention - ISRCTN89936343

Adams, Jo, Bridle, Christopher, Dosanjh, Sukhdeep , Heine, Peter, Lamb, Sarah E., Lord, Joanne, McConkey, Christpher, Nichols, Vivien, Toye, Francine, Underwood, Martin R., Williams, Mark A. and Williamson, Esther M. (2012) Strengthening and stretching for rheumatoid arthritis of the hand (SARAH): design of a randomised controlled trial of a hand and upper limb exercise intervention - ISRCTN89936343. BMC Musculoskeletal Disorders, 13 (230). ISSN 1471-2474

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Background: Rheumatoid Arthritis (RA) commonly affects the hands and wrists with inflammation, deformity, pain, weakness and restricted mobility leading to reduced function. The effectiveness of exercise for RA hands is uncertain, although evidence from small scale studies is promising. The Strengthening And Stretching for Rheumatoid Arthritis of the Hand (SARAH) trial is a pragmatic, multi-centre randomised controlled trial evaluating the clinical and cost effectiveness of adding an optimised exercise programme for hands and upper limbs to best practice usual care for patients with RA. Methods/design. 480 participants with problematic RA hands will be recruited through 17 NHS trusts. Treatments will be provided by physiotherapists and occupational therapists. Participants will be individually randomised to receive either best practice usual care (joint protection advice, general exercise advice, functional splinting and assistive devices) or best practice usual care supplemented with an individualised exercise programme of strengthening and stretching exercises. The study assessors will be blinded to treatment allocation and will follow participants up at four and 12 months. The primary outcome measure is the Hand function subscale of the Michigan Hand Outcome Questionnaire, and secondary outcomes include hand and wrist impairment measures, quality of life, and resource use. Economic and qualitative studies will also be carried out in parallel. Discussion. This paper describes the design and development of a trial protocol of a complex intervention study based in therapy out-patient departments. The findings will provide evidence to support or refute the use of an optimised exercise programme for RA of the hand in addition to best practice usual care. Trial registration. Current Controlled Trials ISRCTN89936343. © 2012 Trial Team et al.; licensee BioMed Central Ltd.

Keywords:adult, arm exercise, arm prosthesis, article, controlled study, cost effectiveness analysis, economic evaluation, functional assessment, functional disease, hand function, hand osteoarthritis, health care utilization, human, kinesiotherapy, major clinical study, methodology, Michigan Hand Outcome Questionnaire, multicenter study, muscle training, outpatient care, patient care, quality of life, questionnaire, randomized controlled trial, rheumatoid arthritis, single blind procedure, splinting, stretching exercise, treatment outcome, Arthritis, Rheumatoid, Exercise Therapy, Follow-Up Studies, Hand, Humans, Muscle Stretching Exercises, Resistance Training, Treatment Outcome, Upper Extremity
Subjects:B Subjects allied to Medicine > B160 Physiotherapy
B Subjects allied to Medicine > B190 Anatomy, Physiology and Pathology not elsewhere classified
Divisions:College of Social Science > Lincoln Institute of Health
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ID Code:23904
Deposited On:28 Sep 2016 14:09

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