Clinical trial NCT01375790: Whole-body Vibration Training in Older People
Official title: Neuromuscular Training With Whole Body Vibration in Older People: A Randomized Multicentre Clinical Trial With Blinded to Evaluator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Aging
Keywords: whole-body vibration
older people
exercise
body balance
muscle performance
falls
physiotherapy
Lead sponsor: Asociacion Colaboracion Cochrane Iberoamericana
Sponsor class: OTHER
First posted: 2011-06-17
Enrollment: 160
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, multicentre, and parallel clinical trial with blinded to evaluator.

The principal hypothesis is that whole-body vibration training plus exercise improves the body balance and prevents falls more than only exercise training in institutionalized older people. The number needed of patients is 160 (80 per group).


Eligibility criteria: Inclusion Criteria:

* Institutionalized older people who were 65 years and older
* The patient consent to participate in the study

Exclusion Criteria:

* Residents who present an acute disease that not resolved during 10 days.
* Residents with a pacemaker (or serious cardiac alterations)
* Residents with epilepsy
* Residents with a high risk of thromboembolism
* Residents with a history of a hip or knee joint replacement
* Residents who not were musculoskeletal disorders and cognitive or physical dysfunction that interfering with test and training procedures.
* Residents that not accept to participate in the study.

Primary outcomes:
measure: Body balance.
timeFrame: at 6 weeks
Secondary outcomes:
measure: Body balance
timeFrame: at six months
measure: Muscle performance
timeFrame: at 6 weeks, and 6 months
measure: Number of falls
timeFrame: during 6 months
measure: Safety of interventions
timeFrame: During 6 months
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Albada Centre Socio Sanitari Parc Taulí
state: Babadell
city: Badalona
country: Spain
facility: Ballesol Badalona
state: Barcelona
city: Barberà del Vallès
country: Spain
facility: Ballesol Barberà
state: Barcelona
city: Sabadell
country: Spain
facility: Residència Allegra
state: Barcelona
city: Barcelona
country: Spain
facility: Residència Poble Nou
city: Barcelona
country: Spain
facility: Ballesol Fabra i Puig
city: Barcelona
country: Spain
facility: Ballesol Almogàvers
city: Barcelona
country: Spain
facility: Residència Mapfre Quavitae
city: Barcelona
country: Spain
facility: Residència AMMA Horta
city: Barcelona
country: Spain
facility: Residència Collserola (Mutuam)
Study officials:
affiliation: • Health Sciences Faculty Blanquerna (Universitat Ramon Llull)
name: Mercè Sitjà Rabert, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sitja-Rabert M, Martinez-Zapata MJ, Fort Vanmeerhaeghe A, Rey Abella F, Romero-Rodriguez D, Bonfill X. Effects of a whole body vibration (WBV) exercise intervention for institutionalized older people: a randomized, multicentre, parallel, clinical trial. J Am Med Dir Assoc. 2015 Feb;16(2):125-31. doi: 10.1016/j.jamda.2014.07.018. Epub 2014 Oct 3.
citation: Sitja-Rabert M, Martinez-Zapata MJ, Fort-Vanmeerhaeghe A, Rey-Abella F, Romero-Rodriguez D, Bonfill X. Whole body vibration for older persons: an open randomized, multicentre, parallel, clinical trial. BMC Geriatr. 2011 Dec 22;11:89. doi: 10.1186/1471-2318-11-89.