Contact information
Type
Scientific
Primary contact
Dr Selwyn Richards
ORCID ID
Contact details
Kings Healthcare NHS Trust
Dept of Rheumatology
Poole NHS Trust
Poole
BH15 2JB
United Kingdom
+44 (0)20 7346 6195
selwyn.richards@kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
REC00109
Study information
Scientific title
Acronym
FIT
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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Fibromyalgia
Intervention
1. Graded aerobic fitness programme (intervention)
2. Programme of relaxation and flexibility
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Participants' self assessment of improvement, tender point count, impact of condition measured by fibromyalgia impact questionnaire, and short form McGill pain questionnaire.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
30/09/1998
Overall trial end date
30/12/2000
Reason abandoned
Eligibility
Participant inclusion criteria
Fibromyalgia
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
132 (added 12/01/10, see publication)
Participant exclusion criteria
Inability to attend classes
Recruitment start date
30/09/1998
Recruitment end date
30/12/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Kings Healthcare NHS Trust
Poole
BH15 2JB
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive London (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12142304
Publication citations
-
Results
Richards SC, Scott DL, Prescribed exercise in people with fibromyalgia: parallel group randomised controlled trial., BMJ, 2002, 325, 7357, 185.