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 |
| Protocol serial number | 11/05 |
| Sponsor | University of Extremadura (Spain) |
| Funders | Health & Dependence Department and Young & Sports Department of Junta de Extremadura (ref: 118/06) (Spain), University of Extremadura (Spain) |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Faculty of Sports Sciences
University of Extremadura
Caceres
10071
Spain
| Phone | +34 927 257460 |
|---|---|
| ngusi@unex.es |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
The following will be assessed at baseline and 3 months: |
| Key secondary outcome measure(s) |
The following will be assessed at baseline and 3 months: |
| Completion date | 30/05/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Target sample size at registration | 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
10071
Spain
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 | 01/08/2011 | Yes | No | |
| Results article | results | 01/02/2012 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
