title: Exercise programme with telephone follow-up for people with hand osteoarthritis - protocol for a randomised controlled trial.
abstract: BACKGROUND
  Hand osteoarthritis (OA) is one of the most prevalent musculoskeletal diseases in an adult population and may have a large influence on an individual's functioning, health-related quality of life and participation in society. Several studies have demonstrated that exercises may reduce pain and improve functioning in people with knee OA, with a similar effect suggested for hip OA. For hand OA, available research is very limited and shows conflicting results, and high-quality randomised controlled trials are warranted.This paper outlines the protocol for a randomised controlled trial that aims to determine the effect of an exercise intervention on self-reported hand activity performance in people with hand OA.
  
  
  METHODS
  Participants with physician-confirmed hand OA according to the ACR clinical criteria are being recruited from two Norwegian OA cohorts: the population-based "Musculoskeletal pain in Ullensaker Study" (MUST) OA cohort, and the hospital-based Oslo Hand OA cohort. Participants are randomised into an intervention- or control group. The control group receives "usual care", whereas the intervention group receives a 12-week exercise intervention. The intervention group attends four group sessions and is instructed to perform the exercise program three times a week at home. Adherence will be captured using self-report. During the eight weeks with no group sessions, the intervention group receives a weekly telephone call. The assessments and group sessions are being conducted locally in Ullensaker Municipality and at Diakonhjemmet Hospital, Oslo. Outcomes are collected at baseline, and at 3 and 6 months. The primary outcome measure is self-reported hand activity performance at 3 months post-randomisation, as measured by the Functional Index for Hand Osteoarthritis (FIHOA); and a patient-generated measure of disability, the Patient-Specific Functional Scale (PSFS). Secondary outcome measures are self-reported OA symptoms (e.g. pain, stiffness and fatigue), the Patient Global Assessment of disease activity, measured hand function (e.g. grip strength, thumb web space and hand dexterity) and health-related quality of life. Cost-utility and cost-effectiveness analyses will be conducted.
  
  
  CONCLUSIONS
  This study will contribute to the knowledge on both the effect and resource use of an exercise programme with telephone follow-up on self-reported hand activity performance among people with hand OA.
  
  
  BACKGROUND
  The trial is registered at ClinicalTrials.gov with registration number: NCT01245842.
authors.affiliation: National Advisory Unit on Rehabilitation in Rheumatology, Diakonhjemmet Hospital, Oslo, PO Box 23 Vindern, N-0319 Oslo, Norway. nina.osteras@medisin.uio.no.
authors.forename: Nina
authors.initials: N
authors.lastname: Østerås
authors.forename: Kåre Birger
authors.initials: KB
authors.lastname: Hagen
authors.forename: Margreth
authors.initials: M
authors.lastname: Grotle
authors.forename: Anne-Lene
authors.initials: AL
authors.lastname: Sand-Svartrud
authors.forename: Petter
authors.initials: P
authors.lastname: Mowinckel
authors.forename: Eline
authors.initials: E
authors.lastname: Aas
authors.forename: Ingvild
authors.initials: I
authors.lastname: Kjeken
mesh_terms: D000328:Adult; D000368:Aged; D002985:Clinical Protocols; D004496:Education, Continuing; D005081:Exercise Therapy / Q000191:economics; D005260:Female; D005500:Follow-Up Studies; D050823:Hand Joints / Q000503:physiopathology; D018737:Hand Strength; D006801:Humans; D008297:Male; D008875:Middle Aged; D009788:Occupational Therapy / Q000193:education; D010003:Osteoarthritis / Q000191:economics / Q000628:therapy*; D059825:Physical Therapists / Q000193:education; D016037:Single-Blind Method; D013689:Telephone