Condition category
Musculoskeletal Diseases
Date applied
18/06/2006
Date assigned
14/07/2006
Last edited
28/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.unex.es

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

  1. 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.

Additional files

Editorial Notes