Prevention of muscular strength and balance loss and osteoporosis using whole-body vibration in women with fibromyalgia
| ISRCTN | ISRCTN16950947 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16950947 |
| Secondary identifying numbers | 11/05 |
- Submission date
- 28/11/2007
- Registration date
- 12/02/2008
- Last edited
- 20/06/2012
- 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
Prof Narcis Gusi
Scientific
Scientific
Faculty of Sports Sciences
University of Extremadura
Caceres
10071
Spain
| Phone | +34 927 257460 |
|---|---|
| ngusi@unex.es |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
| Scientific title | |
| Study acronym | EVFEO/11/05 |
| Study objectives | 1. Whole-body vibration exercise is effective in improving muscular strength in lower limbs and balance in women with fibromyalgia 2. Whole-body vibration exercise is effective in improving health related quality of life in women with fibromyalgia 3. Whole-body vibration is a cost-effective alternative compared to usual health care |
| Ethics approval(s) | Approved by the Biomedic Ethical Committee of the University of Extremadura on 12/06/2005; reference number 11/05 (academic research funded in 2007). |
| Health condition(s) or problem(s) studied | Fibromyalgia |
| Intervention | Intervention group: Three sessions of whole-body vibration per week. Each session consisted of 6 repetitions at 12.6 HZ of whole-body vibration on reciprocal vibrating platform (Galileo 2000, Novotec. Germany). The feet of subject will be aligned perpendicular to usual use (this is a new technique). The time spent in each repetition will be increased 15 seconds every month from 30 second to 1 minute. Control group: Usual care |
| Intervention type | Other |
| Primary outcome measure | The following will be assessed at baseline and 3 months: 1. Balance (Fall risk and postural stability) measured by Biodex Balance 2. Neuromuscular function (isokinetic measurements with surface electromyography measurements) measured by System-3 Biodex Dynamometer and MP100 Biopac 3. Fear to Fall Questionnaire (FES-I) 4. Health related Quality of life: 4.1. EuroQol EQ-5D Instrument (utility index) 4.2. Fibromyalgia Impact Questionnaire 4.3. 15-D instrument (utility index) 4.4. 36-item Short Form health survey (SF-36) (utility index) 5. Health system and societal costs 6. Pain threshold measured by algometer |
| Secondary outcome measures | The following will be assessed at baseline and 3 months: 1. Hand-grip 2. Percentage of fat 3. Visual Analogue Scale for pain (0-10) 4. Visual Analogue Scale for general health (attached to EuroQOL 5D [EQ-5D]) |
| Overall study start date | 30/11/2007 |
| Completion date | 30/05/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Target number of participants | 50 |
| Key inclusion criteria | 1. Women who suffer fibromyalgia according to diagnosis by the American College of Rheumatology criteria 2. Older than 35 years |
| Key exclusion criteria | 1. Contraindications to physical exercise 2. Other physical or psychological therapies different from usual care in the National Health Service (outpatient clinic) 3. Cognitive disease |
| Date of first enrolment | 30/11/2007 |
| Date of final enrolment | 30/05/2008 |
Locations
Countries of recruitment
- Spain
Study participating centre
Faculty of Sports Sciences
Caceres
10071
Spain
10071
Spain
Sponsor information
University of Extremadura (Spain)
University/education
University/education
Avda Elvas s/n
Badajoz
06071
Spain
| Phone | +34 92 428 93 05 |
|---|---|
| vicein@unex.es | |
| Website | http://www.unex.es |
"ROR" |
https://ror.org/0174shg90 |
Funders
Funder type
Government
Health & Dependence Department and Young & Sports Department of Junta de Extremadura (ref: 118/06) (Spain)
No information available
University of Extremadura (Spain)
No information available
Results and Publications
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2011 | Yes | No | |
| Results article | results | 01/02/2012 | Yes | No |
