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

Study website

Contact information

Prof Narcis Gusi
Scientific

Faculty of Sports Sciences
University of Extremadura
Caceres
10071
Spain

Phone +34 927 257460
Email ngusi@unex.es

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typePrevention
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet.
Scientific title
Study acronymEVFEO/11/05
Study objectives1. 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) studiedFibromyalgia
InterventionIntervention 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 typeOther
Primary outcome measureThe 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 measuresThe 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 date30/11/2007
Completion date30/05/2008

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexFemale
Target number of participants50
Key inclusion criteria1. Women who suffer fibromyalgia according to diagnosis by the American College of Rheumatology criteria
2. Older than 35 years
Key exclusion criteria1. 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 enrolment30/11/2007
Date of final enrolment30/05/2008

Locations

Countries of recruitment

  • Spain

Study participating centre

Faculty of Sports Sciences
Caceres
10071
Spain

Sponsor information

University of Extremadura (Spain)
University/education

Avda Elvas s/n
Badajoz
06071
Spain

Phone +34 92 428 93 05
Email vicein@unex.es
Website http://www.unex.es
ROR logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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