Vibratory exercise to prevent falls and osteoporosis in older women in primary care

ISRCTN	ISRCTN76235671
DOI	https://doi.org/10.1186/ISRCTN76235671
Protocol serial number	15/04
Sponsor	University of Extremadura (Spain)
Funder	Health Department of Junta de Extremadura: Sociosanitary Research (SCSS0466) - Spain

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Narcis Gusi
Scientific

Faculty of Sports Sciences
Avda Universidad s/n
Caceres
10071
Spain

Phone	+34 (0)92 725 74 60
Email	ngusi@unex.es

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	EVCOM/15/04
Study objectives	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(s)	Bioethical Committee of the University of Extremadura on 15/09/2004, reference number 15/04
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	1. Bone mass density (dual energy x-ray absorptiometry [DEXA] technique) 2. Fitness (balance, isokinetic strength, vertical jump, walking speed, stairs climbing)
Key secondary outcome measure(s)	Health-related quality of life (EQ-5D, short-form-36 questionnaire [SF-36])
Completion date	01/07/2005

Participant type(s)	Patient
Age group	Senior
Sex	Female
Target sample size at registration	36
Key inclusion criteria	Women older than 60 years old
Key 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
Date of first enrolment	01/11/2004
Date of final enrolment	01/07/2005

Faculty of Sports Sciences

Caceres
10071
Spain

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	30/11/2006		Yes	No