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

This study has been terminated.
(Lack of funding)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01523600
First Posted: February 1, 2012
Last Update Posted: May 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Ministry of Education and Culture, Finland
Pirkanmaa Hospital District
Information provided by (Responsible Party):
Harri Sievanen, UKK Institute
  Purpose
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
Falls 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 (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 Harri Sievanen, 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.

  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01523600


Locations
Finland
Kaukaharjun Seniorikeskus
Tampere, Finland
Kuuselan Seniorikeskus
Tampere, Finland
Tammenlehvä-keskus
Tampere, Finland
Viola-koti
Tampere, Finland
Sponsors and Collaborators
UKK Institute
Ministry of Education and Culture, Finland
Pirkanmaa Hospital District
Investigators
Study Director: Harri Sievanen, ScD The UKK Institute
  More Information

Responsible Party: Harri Sievanen, Research Director, UKK Institute
ClinicalTrials.gov Identifier: NCT01523600     History of Changes
Other Study ID Numbers: 138,04
R11122 ( Other Identifier: Ethics Committee )
First Submitted: January 27, 2012
First Posted: February 1, 2012
Last Update Posted: May 11, 2016
Last Verified: May 2016

Keywords provided by Harri Sievanen, UKK Institute:
whole body vibration
physical functioning
falls
older people
prevention