NCT01734083

Brief Summary

The whole body vibration exercise group will have significantly more improvement in mobility, muscle strength, balance, balance confidence, and cognitive function with a lower fall rate than the 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
66

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
20 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 27, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

November 27, 2012

Status Verified

November 1, 2012

Enrollment Period

2.2 years

First QC Date

November 21, 2012

Last Update Submit

November 26, 2012

Conditions

Dementia

Keywords

rehabilitationexercisefallmusclevibrationmobilitycognition

Outcome Measures

Primary Outcomes (3)

  • Timed-up-and-go test

    A measure of functional mobility

    week 0

  • Timed-up-and-go test

    week 9

  • Timed-up-and-go test

    week 21

Secondary Outcomes (16)

  • Berg balance scale

    week 0

  • Berg balance scale

    week 9

  • Berg balance scale

    week 21

  • Activities-specific balance confidence scale

    week 0

  • Activities-specific balance confidence scale

    week 9

  • +11 more secondary outcomes

Study Arms (2)

Whole body vibration exercise

EXPERIMENTAL

The experimental group will receive 2 sessions of whole body vibration exercise training and conventional exercise per week for a period of 9 weeks. The total duration of vibration exposure per session will range from 4 to 6 minutes. The vibration frequency and amplitude used will be 30 Hz and 1 mm, respectively.

Device: Whole body vibration exerciseBehavioral: Conventional exercise

Conventional exercise

ACTIVE COMPARATOR

This group will receive 2 sessions of conventional exercise training per week for a period of 9 weeks.

Behavioral: Conventional exercise

Interventions

Whole body vibration exerciseDEVICE

The whole body vibration will be delivered by a platform that can generate vibration signals (Powerplate). The total duration of vibration exposure per session will range from 4 to 6 minutes. The vibration bouts (30-45 seconds per bout) will be interspersed with a 1 to 2 minutes of rest period. While standing on the vibration platform, subjects will be instructed to repeat two exercises: (1) static semi-squats, and (2) dynamic semi-squats.

Whole body vibration exercise
Conventional exerciseBEHAVIORAL

The conventional exercise training will involve a combination of upper limb and lower limb stretching and strengthening exercises, balance training, and gait re-education.

Conventional exerciseWhole body vibration exercise

Eligibility Criteria

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

You may qualify if:

  • a diagnosis of mild or moderate dementia, with a Clinical Dementia Rating (CDR) of 1 to 2, and a Cantonese Mini-mental State Examination (CMMSE) score at 10 or above but below the local cutoff for dementia (18-22, depending on education level)
  • able to stand for at least 1 minute with or without hand support
  • living in the community
  • having an informed consent (from the primary caregiver)

You may not qualify if:

  • significant musculoskeletal conditions (e.g. amputations)
  • metal implants in the lower extremity
  • recent fracture in the lower extremity
  • vestibular disorders
  • peripheral vascular disease
  • other serious illnesses or contraindications to exercise.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jockey Club Centre for Positive Ageing

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

DementiaMotor Activity

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersBehavior

Study Officials

  • Marco Pang, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Pang, PhD

CONTACT

852-2766-7156Marco.Pang@polyu.edu.hk

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
Associate Professor

Study Record Dates

First Submitted

November 21, 2012

First Posted

November 27, 2012

Study Start

November 1, 2012

Primary Completion

January 1, 2015

Study Completion

July 1, 2015

Last Updated

November 27, 2012

Record last verified: 2012-11

Locations

HK(1)