Condition category
Musculoskeletal Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
12/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.doh.gov.uk

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

  1. Results

    Richards SC, Scott DL, Prescribed exercise in people with fibromyalgia: parallel group randomised controlled trial., BMJ, 2002, 325, 7357, 185.

Additional files

Editorial Notes