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Whole Body Vibration Training Among Older People Using Sheltered Housing (VAREX)

This study has been terminated.
(Lack of funding)
Ministry of Education and Culture, Finland
Pirkanmaa Hospital District
Information provided by (Responsible Party):
Harri Sievanen, UKK Institute Identifier:
First received: January 27, 2012
Last updated: May 10, 2016
Last verified: May 2016
The purpose of this randomised (double-blind) controlled exercise intervention trial is to determine whether the whole body vibration (WBV) training can effectively improve physical functioning of older people living in or regularly using services of sheltered housing, reduce their fear of falling, and prevent falling. The study comprises a 10-week training period and a 10-month follow-up period.

Condition Intervention Phase
Physical Performance
Fear of Falling
Behavioral: Whole body vibration training
Behavioral: Wellness group
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Whole Body Vibration Training on Physical Functioning and Risk of Falling in Older People Using Sheltered Housing

Resource links provided by NLM:

Further study details as provided by UKK Institute:

Primary Outcome Measures:
  • Number of falls [ Time Frame: One year ]
    Participants keep fall diaries on daily basis and mail the diaries to the investigators in every month. In case of a reported fall, the investigator contacts the participant and enquires the details of the fall.

Secondary Outcome Measures:
  • Physical functioning [ Time Frame: 10 weeks and one year ]
    The standard Short Physical Performance Battery (SPPB) is used for the assessment of participant's balance, walking speed and chair rising time at the baseline, after the 10 week training and after the subsequent 10 month follow-up.In addition, 4-m maximal walking speed , Timed Up and Go (TUG) test and grip strength are assessed at the same time points.

  • Fear of falling [ Time Frame: 10 weeks and one year ]
    The Falls Efficacy Scale (FES-I)is used for the assessment of perceived fear of falling at the baseline, after 10 week training and after the subsequent 10-month follow-up.

Enrollment: 130
Study Start Date: October 2011
Estimated Study Completion Date: December 2016
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Whole body vibration training Behavioral: Whole body vibration training
The intervention comprises a 10-week individually supervised, progressive WBV training done twice a week on a side-alternating device with simultaneous body transferring and slight squatting exercises. At the week one, the duration of a single training bout is 1 x 1 min, and the number of 1 min bouts is weekly increased by one until five bouts is reached. During weeks 4 - 10, the training comprises 5 x 1 min bouts with 1 min rest periods between. During weeks 1 to 3, vibration frequencies are 12 and 18 Hz, which are used alternately. Thereafter, also 26 Hz may be used instead of 18 Hz. In addition, the amplitude of vibration is increased progressively according to a specified protocol. A detailed training diary is kept.
Other Name: Galileo Med M Plus
Active Comparator: Wellness group Behavioral: Wellness group
The intervention comprises a 10-week supervised group training done once a week with the focus on stretching and flexibility exercises done mostly in a sitting position. The duration of a single training session is 45 minutes. A training diary is kept.


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • lives in sheltered housing or uses regularly services provided by sheltered housing
  • ambulatory, able to walk independently with or without a walking aid
  • Mini Mental State Examination (MSSE) points 16 or more

Exclusion Criteria:

  • knee or hip prosthesis
  • osteosynthetic material in lower limbs
  • stiffening operation of the spinal column
  • cardiac pacemaker
  • recent fracture (< 1 yr for lower limb or spinal fractures, < ½ yr for upper limb fractures)
  • recent major surgical operation
  • acute thrombosis or its high risk
  • acute musculoskeletal inflammation
  • gall or bladder stones
  • problematic hernia
  • unstable cardiovascular or other systematic disease
  • tumor
  • diabetic neuropathy
  • strong vertigo
  Contacts and Locations
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Please refer to this study by its identifier: NCT01523600

Kaukaharjun Seniorikeskus
Tampere, Finland
Kuuselan Seniorikeskus
Tampere, Finland
Tampere, Finland
Tampere, Finland
Sponsors and Collaborators
UKK Institute
Ministry of Education and Culture, Finland
Pirkanmaa Hospital District
Study Director: Harri Sievanen, ScD The UKK Institute
  More Information

Responsible Party: Harri Sievanen, Research Director, UKK Institute Identifier: NCT01523600     History of Changes
Other Study ID Numbers: 138,04
R11122 ( Other Identifier: Ethics Committee )
Study First Received: January 27, 2012
Last Updated: May 10, 2016

Keywords provided by UKK Institute:
whole body vibration
physical functioning
older people
prevention processed this record on May 25, 2017