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

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.

Study Overview

• Status: Terminated
• Conditions: Fear of Falling; Falls; Physical Performance
• Intervention / Treatment: Behavioral: Whole body vibration training; Behavioral: Wellness group

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Phase 4

Contacts and Locations

Study Locations

• Finland
  • Tampere, Finland
    • Kaukaharjun Seniorikeskus
  • Tampere, Finland
    • Kuuselan Seniorikeskus
  • Tampere, Finland
    • Tammenlehvä-keskus
  • Tampere, Finland
    • Viola-koti

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of falls	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.	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical functioning	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.	10 weeks and one year
Fear of falling	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.	10 weeks and one year

Collaborators and Investigators

• Sponsor: UKK Institute
• Collaborators: Pirkanmaa Hospital District; Ministry of Education and Culture, Finland
• Investigators: Study Director: Harri Sievanen, ScD, The UKK Institute

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): March 1, 2014
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: January 27, 2012
• First Submitted That Met QC Criteria: January 27, 2012
• First Posted (Estimate): February 1, 2012

Study Record Updates

• Last Update Posted (Estimate): May 11, 2016
• Last Update Submitted That Met QC Criteria: May 10, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: prevention; falls; whole body vibration; older people; physical functioning
• Other Study ID Numbers: 138,04; R11122 (Other Identifier: Ethics Committee)