- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01734083
Whole Body Vibration Exercise for Elderly With Cognitive Impairments
November 26, 2012 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 Community-dwelling Elderly With Cognitive Impairments
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
66
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
- Jockey Club Centre for Positive Ageing
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Contact:
- Timothy Kwok, MD
- Phone Number: 852-2636-6323
- Email: tkwok@cuhk.edu.hk
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Principal Investigator:
- Timothy Kwok, MD
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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:
- 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.
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 exercise
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.
|
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.
The conventional exercise training will involve a combination of upper limb and lower limb stretching and strengthening exercises, balance training, and gait re-education.
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Active Comparator: Conventional exercise
This group will receive 2 sessions of conventional exercise training per week for a period of 9 weeks.
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The conventional exercise training will involve a combination of upper limb and lower limb stretching and strengthening exercises, balance training, and gait re-education.
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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
|
A measure of functional mobility
|
week 0
|
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Timed-up-and-go test
Time Frame: week 9
|
week 9
|
|
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Timed-up-and-go test
Time Frame: week 21
|
week 21
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Berg balance scale
Time Frame: week 0
|
week 0
|
|
|
Activities-specific balance confidence scale
Time Frame: week 0
|
week 0
|
|
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Berg balance scale
Time Frame: week 9
|
week 9
|
|
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Berg balance scale
Time Frame: week 21
|
week 21
|
|
|
Activities-specific balance confidence scale
Time Frame: week 9
|
week 9
|
|
|
Activities-specific balance confidence scale
Time Frame: week 21
|
week 21
|
|
|
five times sit-to-stand test
Time Frame: week 0
|
week 0
|
|
|
five times sit-to-stand test
Time Frame: week 9
|
week 9
|
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five times sit-to-stand test
Time Frame: week 21
|
week 21
|
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Mini-Mental State Examination
Time Frame: week 0
|
week 0
|
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Mini-Mental State Examination
Time Frame: week 9
|
week 9
|
|
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Mini-Mental State Examination
Time Frame: week 21
|
week 21
|
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Quality of Life in Alzheimer's disease
Time Frame: week 0
|
week 0
|
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Quality of Life in Alzheimer's disease
Time Frame: week 9
|
week 9
|
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Quality of Life in Alzheimer's disease
Time Frame: week 21
|
week 21
|
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incidence of falls
Time Frame: daily starting from week 0 to week 33
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Incidence of falls will be recorded by using fall diaries.
|
daily starting from week 0 to week 33
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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)
January 1, 2015
Study Completion (Anticipated)
July 1, 2015
Study Registration Dates
First Submitted
November 21, 2012
First Submitted That Met QC Criteria
November 26, 2012
First Posted (Estimate)
November 27, 2012
Study Record Updates
Last Update Posted (Estimate)
November 27, 2012
Last Update Submitted That Met QC Criteria
November 26, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSEARS20120929006
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.