Whole Body Vibration Training Among Older People Using Sheltered Housing

Falls Clinical Trial

— VAREX  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01523600
• Other study ID #: 138,04
• Secondary ID: R11122
• Status: Terminated
• Phase: Phase 4
• First received: January 27, 2012
• Last updated: May 10, 2016
• Start date: October 2011
• Est. completion date: December 2016

Study information

• Verified date: May 2016
• Source: UKK Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 130
• Est. completion date: December 2016
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Falls
• Fear of Falling
• Physical Performance

Intervention

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.
• 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.

Locations

Country	Name	City	State
Finland	Kaukaharjun Seniorikeskus	Tampere
Finland	Kuuselan Seniorikeskus	Tampere
Finland	Tammenlehvä-keskus	Tampere
Finland	Viola-koti	Tampere

Sponsors (3)

Lead Sponsor	Collaborator
UKK Institute	Ministry of Education and Culture, Finland, Pirkanmaa Hospital District

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No