Contact information
Type
Scientific
Primary contact
Prof Narcis Gusi
ORCID ID
Contact details
Faculty of Sports Sciences
Avda Universidad s/n
Caceres
10071
Spain
+34 (0)92 725 74 60
ngusi@unex.es
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
15/04
Study information
Scientific title
Acronym
EVCOM/15/04
Study hypothesis
1. Vibratory exercise reduces bone loss more than walk-based exercise
2. Vibratory exercise maintains the fitness (balance, lower limbs strength etc.) more than walk-based exercise
Ethics approval
Bioethical Committee of the University of Extremadura on 15/09/2004, reference number 15/04
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
Prevention of falls and osteoporosis in postmenopausal women
Intervention
1. Intervention group: eight months of vibratory exercise
2. Control group: eight months of walk-based exercise
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Bone mass density (dual energy x-ray absorptiometry [DEXA] technique)
2. Fitness (balance, isokinetic strength, vertical jump, walking speed, stairs climbing)
Secondary outcome measures
Health-related quality of life (EQ-5D, short-form-36 questionnaire [SF-36])
Overall trial start date
01/11/2004
Overall trial end date
01/07/2005
Reason abandoned
Eligibility
Participant inclusion criteria
Women older than 60 years old
Participant type
Patient
Age group
Senior
Gender
Female
Target number of participants
36
Participant exclusion criteria
1. Contraindications to physical exercise
2. Disease or drugs treatment that could influence measures such as bone metabolism or strength
3. Other physical or psychological therapies
4. Cognitive disease
5. Nutritional deficit in vitamin D or calcium
6. Smoking or alcohol consumption
Recruitment start date
01/11/2004
Recruitment end date
01/07/2005
Locations
Countries of recruitment
Spain
Trial participating centre
Faculty of Sports Sciences
Caceres
10071
Spain
Sponsor information
Organisation
University of Extremadura (Spain)
Sponsor details
Avda Elvas s/n
Badajoz
06071
Spain
+34 (0)92 428 93 05
vicein@unex.es
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Health Department of Junta de Extremadura: Sociosanitary Research (SCSS0466) - Spain
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17137514
Publication citations
-
Results
Gusi N, Raimundo A, Leal A, Low-frequency vibratory exercise reduces the risk of bone fracture more than walking: a randomized controlled trial., BMC Musculoskelet Disord, 2006, 7, 92, doi: 10.1186/1471-2474-7-92.