A randomised controlled trial of exercise prescription on Fibromyalgia (The Fibromyalgia Intervention Trial:- FIT)
| ISRCTN | ISRCTN65116271 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65116271 |
| Protocol serial number | REC00109 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive London (UK) |
- 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
Scientific
Kings Healthcare NHS Trust
Dept of Rheumatology
Poole NHS Trust
Poole
BH15 2JB
United Kingdom
| Phone | +44 (0)20 7346 6195 |
|---|---|
| selwyn.richards@kcl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Participants' self assessment of improvement, tender point count, impact of condition measured by fibromyalgia impact questionnaire, and short form McGill pain questionnaire. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/12/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 132 |
| 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 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Kings Healthcare NHS Trust
Poole
BH15 2JB
United Kingdom
BH15 2JB
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
