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A randomised controlled trial of exercise prescription on Fibromyalgia (The Fibromyalgia Intervention Trial:- FIT)
ISRCTN ISRCTN65116271
ClinicalTrials.gov identifier
Public title A randomised controlled trial of exercise prescription on Fibromyalgia (The Fibromyalgia Intervention Trial:- FIT)
Scientific title
Acronym FIT
Serial number at source REC00109
Study hypothesis To evaluate the efficacy of a class based exercise prescription program for fibromyalgia (FM). The assessment was performed by a randomised controlled trial comparing the active treatment of graded aerobic fitness exercise to a control treatment of relaxation and flexibility.
Lay summary
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Fibromyalgia
Participants - inclusion criteria Fibromyalgia
Participants - exclusion criteria Inability to attend classes
Anticipated start date 30/09/1998
Anticipated end date 30/12/2000
Status of trial Completed
Patient information material
Target number of participants 132 (added 12/01/10, see publication)
Interventions 1. Graded aerobic fitness programme (intervention)
2. Programme of relaxation and flexibility
Primary outcome measure(s) Participants' self assessment of improvement, tender point count, impact of condition measured by fibromyalgia impact questionnaire, and short form McGill pain questionnaire.
Secondary outcome measure(s) Not provided at time of registration
Sources of funding NHS Executive London (UK)
Trial website
Publications 2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12142304
Contact name Dr  Selwyn  Richards
  Address Kings Healthcare NHS Trust
Dept of Rheumatology
Poole NHS Trust
  City/town Poole
  Zip/Postcode BH15 2JB
  Country United Kingdom
  Tel +44 (0)20 7346 6195
  Email selwyn.richards@kcl.ac.uk
Sponsor NHS R&D Regional Programme Register - Department of Health (UK)
  Address The Department of Health
Richmond House
79 Whitehall
  City/town London
  Zip/Postcode SW1A 2NL
  Country United Kingdom
  Tel +44 (0)20 7307 2622
  Fax +44 (0)20 7307 2623
  Email dhmail@doh.gsi.org.uk
  Sponsor website: http://www.doh.gov.uk
Date applied 23/01/2004
Last edited 12/01/2010
Date ISRCTN assigned 23/01/2004
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