Whole Body Vibration Training Among Older People Using Sheltered Housing

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Whole Body Vibration Training on Physical Functioning and Risk of Falling in Older People Using Sheltered Housing

Conditions
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Falls, Physical Performance, Fear of Falling

Intervention / Treatment
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* Behavioral: Whole body vibration training
* Behavioral: Wellness group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Whole body vibration training<br> | Behavioral: Whole body vibration training<br>* 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.<br>* Other names: Galileo Med M Plus;|
| Active Comparator: Wellness group<br> | Behavioral: Wellness group<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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whole body vibration, physical functioning, falls, older people, prevention