A randomised controlled trial of exercise prescription on Fibromyalgia (The Fibromyalgia Intervention Trial:- FIT)

ISRCTN ISRCTN65116271
DOI https://doi.org/10.1186/ISRCTN65116271
Secondary identifying numbers REC00109
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
12/01/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Selwyn Richards
Scientific

Kings Healthcare NHS Trust
Dept of Rheumatology
Poole NHS Trust
Poole
BH15 2JB
United Kingdom

Phone +44 (0)20 7346 6195
Email selwyn.richards@kcl.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Scientific title
Study acronymFIT
Study objectivesTo 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.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedFibromyalgia
Intervention1. Graded aerobic fitness programme (intervention)
2. Programme of relaxation and flexibility
Intervention typeOther
Primary outcome measureParticipants' self assessment of improvement, tender point count, impact of condition measured by fibromyalgia impact questionnaire, and short form McGill pain questionnaire.
Secondary outcome measuresNot provided at time of registration
Overall study start date30/09/1998
Completion date30/12/2000

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants132 (added 12/01/10, see publication)
Key inclusion criteriaFibromyalgia
Key exclusion criteriaInability to attend classes
Date of first enrolment30/09/1998
Date of final enrolment30/12/2000

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Kings Healthcare NHS Trust
Poole
BH15 2JB
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive London (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 27/07/2002 Yes No