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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

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 design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Scientific title
Study acronym	FIT
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Fibromyalgia
Intervention	1. Graded aerobic fitness programme (intervention) 2. Programme of relaxation and flexibility
Intervention type	Other
Primary outcome measure	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 study start date	30/09/1998
Completion date	30/12/2000

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	132 (added 12/01/10, see publication)
Key inclusion criteria	Fibromyalgia
Key exclusion criteria	Inability to attend classes
Date of first enrolment	30/09/1998
Date of final enrolment	30/12/2000

Kings Healthcare NHS Trust

Poole
BH15 2JB
United Kingdom

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

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

Government

NHS Executive London (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

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