search
Back to results

Whole Body Vibration Exercise for Elderly With Cognitive Impairments

Primary Purpose

Dementia

Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Whole body vibration exercise
Conventional exercise
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia focused on measuring rehabilitation, exercise, fall, muscle, vibration, mobility, cognition

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.

Sites / Locations

  • Jockey Club Centre for Positive AgeingRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Whole body vibration exercise

Conventional exercise

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Timed-up-and-go test
A measure of functional mobility
Timed-up-and-go test
Timed-up-and-go test

Secondary Outcome Measures

Berg balance scale
Berg balance scale
Berg balance scale
Activities-specific balance confidence scale
Activities-specific balance confidence scale
Activities-specific balance confidence scale
five times sit-to-stand test
five times sit-to-stand test
five times sit-to-stand test
Mini-Mental State Examination
Mini-Mental State Examination
Mini-Mental State Examination
Quality of Life in Alzheimer's disease
Quality of Life in Alzheimer's disease
Quality of Life in Alzheimer's disease
incidence of falls
Incidence of falls will be recorded by using fall diaries.

Full Information

First Posted
November 21, 2012
Last Updated
November 26, 2012
Sponsor
The Hong Kong Polytechnic University
Collaborators
Chinese University of Hong Kong
search

1. Study Identification

Unique Protocol Identification Number
NCT01734083
Brief Title
Whole Body Vibration Exercise for Elderly With Cognitive Impairments
Official Title
The Effects of Whole Body Vibration Exercise Training on Physical Functioning and Falls in Community-dwelling Elderly With Cognitive Impairments
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
November 2012 (undefined)
Primary Completion Date
January 2015 (Anticipated)
Study Completion Date
July 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
Chinese University of Hong Kong

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
rehabilitation, exercise, fall, muscle, vibration, mobility, cognition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Whole body vibration exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional exercise
Arm Type
Active Comparator
Arm Description
This group will receive 2 sessions of conventional exercise training per week for a period of 9 weeks.
Intervention Type
Device
Intervention Name(s)
Whole body vibration exercise
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Conventional exercise
Intervention Description
The conventional exercise training will involve a combination of upper limb and lower limb stretching and strengthening exercises, balance training, and gait re-education.
Primary Outcome Measure Information:
Title
Timed-up-and-go test
Description
A measure of functional mobility
Time Frame
week 0
Title
Timed-up-and-go test
Time Frame
week 9
Title
Timed-up-and-go test
Time Frame
week 21
Secondary Outcome Measure Information:
Title
Berg balance scale
Time Frame
week 0
Title
Berg balance scale
Time Frame
week 9
Title
Berg balance scale
Time Frame
week 21
Title
Activities-specific balance confidence scale
Time Frame
week 0
Title
Activities-specific balance confidence scale
Time Frame
week 9
Title
Activities-specific balance confidence scale
Time Frame
week 21
Title
five times sit-to-stand test
Time Frame
week 0
Title
five times sit-to-stand test
Time Frame
week 9
Title
five times sit-to-stand test
Time Frame
week 21
Title
Mini-Mental State Examination
Time Frame
week 0
Title
Mini-Mental State Examination
Time Frame
week 9
Title
Mini-Mental State Examination
Time Frame
week 21
Title
Quality of Life in Alzheimer's disease
Time Frame
week 0
Title
Quality of Life in Alzheimer's disease
Time Frame
week 9
Title
Quality of Life in Alzheimer's disease
Time Frame
week 21
Title
incidence of falls
Description
Incidence of falls will be recorded by using fall diaries.
Time Frame
daily starting from week 0 to week 33

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marco Pang, PhD
Phone
852-2766-7156
Email
Marco.Pang@polyu.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Pang, PhD
Organizational Affiliation
Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jockey Club Centre for Positive Ageing
City
Shatin
State/Province
New Territories
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timothy Kwok, MD
Phone
852-2636-6323
Email
tkwok@cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Timothy Kwok, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
16372905
Citation
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.
Results Reference
background
PubMed Identifier
15706558
Citation
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.
Results Reference
background

Learn more about this trial

Whole Body Vibration Exercise for Elderly With Cognitive Impairments

We'll reach out to this number within 24 hrs