NCT01735682

Brief Summary

It is hypothesized that whole body vibration exercise group will have significantly more improvement in physical functioning and reduction in fall incidence among institutionalized elderly, compared with conventional exercise group and control group.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 28, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

May 30, 2014

Status Verified

May 1, 2014

Enrollment Period

2.4 years

First QC Date

November 20, 2012

Last Update Submit

May 29, 2014

Conditions

Geriatric Disorder

Keywords

older adultsexercisebalancegaitfallrehabilitationvibrationmuscle

Outcome Measures

Primary Outcomes (2)

  • Timed-Up-and-Go test

    It is a measure of functional mobility

    week 0

  • Timed-up-and-go test

    week 8

Secondary Outcomes (17)

  • Berg balance scale

    week 0

  • Berg balance scale

    week 8

  • leg extension strength

    week 0

  • leg extension strength

    week 8

  • shoulder abduction strength

    week 0

  • +12 more secondary outcomes

Study Arms (3)

Whole body vibration

EXPERIMENTAL

This group will receive whole body vibration and conventional exercise training (1 hour per session, 3 sessions per week, for 8 consecutive weeks).

Device: Whole body vibration

Conventional exercise

ACTIVE COMPARATOR

This group will receive convention exercise training (1 hour per session, 3 sessions per week, for 8 consecutive weeks).

Behavioral: Conventional exercise

Control

ACTIVE COMPARATOR

This group will have exercise training that involve only the upper limbs (about 30 minutes per session, 3 sessions per week, for 8 consecutive weeks).

Behavioral: Control

Interventions

Whole body vibrationDEVICE

The vibration frequency and amplitude used will be 30-40 Hz and 1mm, respectively. The total exposure to the vibration stimulation is 4 minutes.

Whole body vibration
Conventional exerciseBEHAVIORAL

The conventional exercise training involves upper limb and lower limb strengthening exercises using sandbags.

Conventional exercise
ControlBEHAVIORAL

The control treatment involves exercises of the upper limbs.

Control

Eligibility Criteria

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

You may qualify if:

  • Functional Ambulation Category 1 to 4
  • able to understand simple verbal commands
  • able to tolerate intermittent physical activity for at least 45 minutes
  • able to perform knee flexion \>45 degree
  • able to stand with or without support for 1 minute or more

You may not qualify if:

  • peripheral vascular disease
  • any symptoms associated with vestibular disorder
  • any contraindications to exercise (e.g. unstable angina)
  • any serious illnesses that preclude participation (e.g. cancer)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shatin Hospital

Shatin, New Territories, Hong Kong

RECRUITING

Related Publications (2)

  • Bautmans I, Van Hees E, Lemper JC, Mets T. The feasibility of Whole Body Vibration in institutionalised elderly persons and its influence on muscle performance, balance and mobility: a randomised controlled trial [ISRCTN62535013]. BMC Geriatr. 2005 Dec 22;5:17. doi: 10.1186/1471-2318-5-17.

    PMID: 16372905BACKGROUND

  • Bruyere O, Wuidart MA, Di Palma E, Gourlay M, Ethgen O, Richy F, Reginster JY. Controlled whole body vibration to decrease fall risk and improve health-related quality of life of nursing home residents. Arch Phys Med Rehabil. 2005 Feb;86(2):303-7. doi: 10.1016/j.apmr.2004.05.019.

    PMID: 15706558BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Marco Pang, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Philip Chan, MSc

CONTACT

852-9851-1382cfl083@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 20, 2012

First Posted

November 28, 2012

Study Start

November 1, 2012

Primary Completion

April 1, 2015

Study Completion

October 1, 2015

Last Updated

May 30, 2014

Record last verified: 2014-05

Locations

HK(1)