NCT01523600

Brief 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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2011

Longer than P75 for phase_4

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 1, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

May 11, 2016

Status Verified

May 1, 2016

Enrollment Period

2.4 years

First QC Date

January 27, 2012

Last Update Submit

May 10, 2016

Conditions

FallsPhysical PerformanceFear of Falling

Keywords

whole body vibrationphysical functioningfallsolder peopleprevention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Physical functioning

    10 weeks and one year

  • Fear of falling

    10 weeks and one year

Study Arms (2)

Whole body vibration training

EXPERIMENTAL
Behavioral: Whole body vibration training

Wellness group

ACTIVE COMPARATOR
Behavioral: Wellness group

Interventions

Whole body vibration trainingBEHAVIORAL

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.

Also known as: Galileo Med M Plus
Whole body vibration training
Wellness groupBEHAVIORAL

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.

Wellness group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Kaukaharjun Seniorikeskus

Tampere, Finland

Location

Kuuselan Seniorikeskus

Tampere, Finland

Location

Tammenlehvä-keskus

Tampere, Finland

Location

Viola-koti

Tampere, Finland

Location

Study Officials

  • Harri Sievanen, ScD

    The UKK Institute

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Director

Study Record Dates

First Submitted

January 27, 2012

First Posted

February 1, 2012

Study Start

October 1, 2011

Primary Completion

March 1, 2014

Study Completion

December 1, 2016

Last Updated

May 11, 2016

Record last verified: 2016-05

Locations

FI(4)