title: 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.
abstract: 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
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry CV4 7AL, UK.
authors.forename: Jo
authors.initials: J
authors.lastname: Adams
authors.forename: Chris
authors.initials: C
authors.lastname: Bridle
authors.forename: Sukhdeep
authors.initials: S
authors.lastname: Dosanjh
authors.forename: Peter
authors.initials: P
authors.lastname: Heine
authors.forename: Sarah E
authors.initials: SE
authors.lastname: Lamb
authors.forename: Joanne
authors.initials: J
authors.lastname: Lord
authors.forename: Christopher
authors.initials: C
authors.lastname: McConkey
authors.forename: Vivien
authors.initials: V
authors.lastname: Nichols
authors.forename: Francine
authors.initials: F
authors.lastname: Toye
authors.forename: Martin R
authors.initials: MR
authors.lastname: Underwood
authors.forename: Mark A
authors.initials: MA
authors.lastname: Williams
authors.forename: Esther M
authors.initials: EM
authors.lastname: Williamson
mesh_terms: D001172:Arthritis, Rheumatoid / Q000453:epidemiology / Q000503:physiopathology / Q000534:rehabilitation*; D005081:Exercise Therapy / Q000379:methods; D005500:Follow-Up Studies; D006225:Hand / Q000473:pathology / Q000502:physiology*; D006801:Humans; D052580:Muscle Stretching Exercises / Q000379:methods*; D055070:Resistance Training / Q000379:methods*; D016896:Treatment Outcome; D034941:Upper Extremity / Q000502:physiology*