title: Whole body vibration for older persons: an open randomized, multicentre, parallel, clinical trial.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT01375790.
authors.affiliation: Physiotherapy Research Group (GReFis), Blanquerna School of Health Science (Universitat Ramon Llull), Barcelona, Spain. mercesr@blanquerna.url.edu
authors.forename: Mercè
authors.initials: M
authors.lastname: Sitjà-Rabert
authors.forename: Ma José
authors.initials: MJ
authors.lastname: Martínez-Zapata
authors.forename: Azahara
authors.initials: A
authors.lastname: Fort-Vanmeerhaeghe
authors.forename: Ferran
authors.initials: F
authors.lastname: Rey-Abella
authors.forename: Daniel
authors.initials: D
authors.lastname: Romero-Rodríguez
authors.forename: Xavier
authors.initials: X
authors.lastname: Bonfill
mesh_terms: D000058:Accidental Falls / Q000517:prevention & control; D000369:Aged, 80 and over; D005081:Exercise Therapy / Q000295:instrumentation / Q000379:methods*; D016330:Frail Elderly; D005684:Gait; D006801:Humans; D053580:Muscle Strength; D004856:Postural Balance; D011788:Quality of Life; D012107:Research Design; D014732:Vibration