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Open Access Study protocol

Whole body vibration for older persons: an open randomized, multicentre, parallel, clinical trial

Mercè Sitjà-Rabert1*, Mª José Martínez-Zapata2, Azahara Fort-Vanmeerhaeghe3, Ferran Rey-Abella1, Daniel Romero-Rodríguez3 and Xavier Bonfill24

Author Affiliations

1 Physiotherapy Research Group (GReFis), Blanquerna School of Health Science (Universitat Ramon Llull), Barcelona, Spain

2 Iberoamerican Cochrane Centre. Institute of Biomedical Research (IIB Sant Pau); Universitat Autònoma de Barcelona; CIBER Epidemiología y Salud Pública, CIBERESP, Barcelona, Spain

3 EUSES Health and Sport Sciences School, Universitat de Girona, Girona, Spain

4 Public Health and Clinical Epidemiology Service. Hospital de la Santa Creu i Sant Pau, Barcelona, Spain

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BMC Geriatrics 2011, 11:89  doi:10.1186/1471-2318-11-89

Published: 22 December 2011

Abstract

Background

Institutionalized older persons have a poor functional capacity. Including physical exercise in their routine activities decreases their frailty and improves their quality of life. Whole-body vibration (WBV) training is a type of exercise that seems beneficial in frail older persons to improve their functional mobility, but the evidence is inconclusive. This trial will compare the results of exercise with WBV and exercise without WBV in improving body balance, muscle performance and fall prevention in institutionalized older persons.

Methods/Design

An open, multicentre and parallel randomized clinical trial with blinded assessment. 160 nursing home residents aged over 65 years and of both sexes will be identified to participate in the study. Participants will be centrally randomised and allocated to interventions (vibration or exercise group) by telephone. The vibration group will perform static/dynamic exercises (balance and resistance training) on a vibratory platform (Frequency: 30-35 Hz; Amplitude: 2-4 mm) over a six-week training period (3 sessions/week). The exercise group will perform the same exercise protocol but without a vibration stimuli platform. The primary outcome measure is the static/dynamic body balance. Secondary outcomes are muscle strength and, number of new falls. Follow-up measurements will be collected at 6 weeks and at 6 months after randomization. Efficacy will be analysed on an intention-to-treat (ITT) basis and 'per protocol'. The effects of the intervention will be evaluated using the "t" test, Mann-Witney test, or Chi-square test, depending on the type of outcome. The final analysis will be performed 6 weeks and 6 months after randomization.

Discussion

This study will help to clarify whether WBV training improves body balance, gait mobility and muscle strength in frail older persons living in nursing homes. As far as we know, this will be the first study to evaluate the efficacy of WBV for the prevention of falls.

Trial Registration

ClinicalTrials.gov: NCT01375790