- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01735682
Whole Body Vibration Exercise Training for Institutionalized Elderly
May 29, 2014 updated by: Marco Yiu-Chung Pang, The Hong Kong Polytechnic University
The Effects of Whole Body Vibration Exercise Training on Physical Functioning and Falls in Institutionalized Elderly: a Randomized Controlled Trial
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
68
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Territories
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Shatin, New Territories, Hong Kong
- Recruiting
- Shatin Hospital
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Contact:
- Philip Chan, MSc
- Phone Number: 852-9851-1382
- Email: cfl083@gmail.com
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Whole body vibration
This group will receive whole body vibration and conventional exercise training (1 hour per session, 3 sessions per week, for 8 consecutive weeks).
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The vibration frequency and amplitude used will be 30-40 Hz and 1mm, respectively.
The total exposure to the vibration stimulation is 4 minutes.
|
Active Comparator: Conventional exercise
This group will receive convention exercise training (1 hour per session, 3 sessions per week, for 8 consecutive weeks).
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The conventional exercise training involves upper limb and lower limb strengthening exercises using sandbags.
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Active Comparator: Control
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).
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The control treatment involves exercises of the upper limbs.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Timed-Up-and-Go test
Time Frame: week 0
|
It is a measure of functional mobility
|
week 0
|
Timed-up-and-go test
Time Frame: week 8
|
week 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Berg balance scale
Time Frame: week 0
|
week 0
|
|
Berg balance scale
Time Frame: week 8
|
week 8
|
|
leg extension strength
Time Frame: week 0
|
week 0
|
|
leg extension strength
Time Frame: week 8
|
week 8
|
|
shoulder abduction strength
Time Frame: week 0
|
week 0
|
|
shoulder abduction strength
Time Frame: week 8
|
week 8
|
|
elbow flexion strength
Time Frame: week 0
|
week 0
|
|
elbow flexion strength
Time Frame: week 8
|
week 8
|
|
six minute walk test
Time Frame: week 0
|
week 0
|
|
six minute walk test
Time Frame: week 8
|
week 8
|
|
Activities-specific balance confidence scale
Time Frame: week 0
|
week 0
|
|
Activities-specific balance confidence scale
Time Frame: week 8
|
week 8
|
|
Quick DASH
Time Frame: week 0
|
A measure of upper limb function
|
week 0
|
Quick DASH
Time Frame: week 8
|
week 8
|
|
Physiological Profile Assessment: short form
Time Frame: week 0
|
week 0
|
|
Physiological Profile Assessment: short form
Time Frame: week 8
|
week 8
|
|
falls incidence
Time Frame: Daily from week 0 to 12 months after termination of treatment/control period
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Daily from week 0 to 12 months after termination of treatment/control period
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Marco Pang, PhD, Hong Kong Polytechnic University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2012
Primary Completion (Anticipated)
April 1, 2015
Study Completion (Anticipated)
October 1, 2015
Study Registration Dates
First Submitted
November 20, 2012
First Submitted That Met QC Criteria
November 25, 2012
First Posted (Estimate)
November 28, 2012
Study Record Updates
Last Update Posted (Estimate)
May 30, 2014
Last Update Submitted That Met QC Criteria
May 29, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HSEARS20120730001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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