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

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ClinicalTrials.gov Identifier: NCT01523600
Recruitment Status : Terminated (Lack of funding)
First Posted : February 1, 2012
Last Update Posted : May 11, 2016
Sponsor:
Collaborators:
Ministry of Education and Culture, Finland
Pirkanmaa Hospital District
Information provided by (Responsible Party):
Harri Sievanen, UKK Institute

January 27, 2012
February 1, 2012
May 11, 2016
October 2011
March 2014   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01523600 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
  • 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.
Not Provided
Not Provided
 
Whole Body Vibration Training Among Older People Using Sheltered Housing
Effect of Whole Body Vibration Training on Physical Functioning and Risk of Falling in Older People Using Sheltered Housing
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
  • Falls
  • Physical Performance
  • Fear of Falling
  • 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
  • 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.
  • Experimental: Whole body vibration training
    Intervention: Behavioral: Whole body vibration training
  • Active Comparator: Wellness group
    Intervention: Behavioral: Wellness group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
130
200
December 2016
March 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
65 Years and older   (Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Finland
 
 
NCT01523600
138,04
R11122 ( Other Identifier: Ethics Committee )
No
Not Provided
Not Provided
Harri Sievanen, UKK Institute
UKK Institute
  • Ministry of Education and Culture, Finland
  • Pirkanmaa Hospital District
Study Director: Harri Sievanen, ScD The UKK Institute
UKK Institute
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP