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

This study is currently recruiting participants.
Verified September 2012 by UKK Institute
Sponsor:
Collaborators:
Finnish Ministry for Education and Culture
Pirkanmaa Hospital District
Information provided by (Responsible Party):
Harri Sievanen, UKK Institute
ClinicalTrials.gov Identifier:
NCT01523600
First received: January 27, 2012
Last updated: September 12, 2012
Last verified: September 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by UKK Institute:

Primary Outcome Measures:
  • Number of falls [ Time Frame: One year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 200
Study Start Date: October 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01523600

Contacts
Contact: Maarit Piirtola, PhD, PT +358-3-2829272 maarit.piirtola@utu.fi
Contact: Saija Karinkanta, PhD, PT +358-3-2829223 saija.karinkanta@uta.fi

Locations
Finland
Viola-koti Completed
Tampere, Finland
Tammenlehvä-keskus Completed
Tampere, Finland
Kuuselan Seniorikeskus Completed
Tampere, Finland
Kaukaharjun Seniorikeskus Recruiting
Tampere, Finland
Peurankalliokeskus Not yet recruiting
Tampere, Finland
Sponsors and Collaborators
UKK Institute
Finnish Ministry for Education and Culture
Pirkanmaa Hospital District
Investigators
Study Director: Harri Sievanen, ScD The UKK Institute
  More Information

No publications provided

Responsible Party: Harri Sievanen, Research Director, UKK Institute
ClinicalTrials.gov Identifier: NCT01523600     History of Changes
Other Study ID Numbers: 138,04, R11122
Study First Received: January 27, 2012
Last Updated: September 12, 2012
Health Authority: Finland: Ethics Committee

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

ClinicalTrials.gov processed this record on June 18, 2013