Whole Body Vibration Training Among Older People Using Sheltered Housing (VAREX)
|ClinicalTrials.gov Identifier: NCT01523600|
Recruitment Status : Terminated (Lack of funding)
First Posted : February 1, 2012
Last Update Posted : May 11, 2016
|Condition or disease||Intervention/treatment||Phase|
|Falls Physical Performance Fear of Falling||Behavioral: Whole body vibration training Behavioral: Wellness group||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Effect of Whole Body Vibration Training on Physical Functioning and Risk of Falling in Older People Using Sheltered Housing|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||March 2014|
|Estimated Study Completion Date :||December 2016|
|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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01523600
|Study Director:||Harri Sievanen, ScD||The UKK Institute|