DementiaNCT01734083
Whole Body Vibration Exercise for Elderly With Cognitive Impairments
A study testing Whole body vibration exercise and Conventional exercise in people with Dementia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Whole body vibration exercise and Conventional exercise
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteHong Kong
- Study dates
- Nov 2012to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Jockey Club Centre for Positive Ageing
Shatin, New Territories
Timothy Kwok, MD, 852-2636-6323, tkwok@cuhk.edu.hk
Timothy Kwok, MD
About this study
Official title: 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.
- Conditions
- Dementia
- Being tested
- Whole body vibration exercise, Conventional exercise
- Keywords
- rehabilitation, exercise, fall, muscle, vibration, mobility, cognition
- Medical subject headings
- Dementia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Conventional exerciseBehavioural
The conventional exercise training will involve a combination of upper limb and lower limb stretching and strengthening exercises, balance training, and gait re-education.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Whole body vibration exercise; Behavioral: Conventional exercise |
| Conventional exercise | Active comparator | This group will receive 2 sessions of conventional exercise training per week for a period of 9 weeks. Receives: Behavioral: Conventional exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed-up-and-go test
A measure of functional mobility
Measured: week 0
Timed-up-and-go test
Measured: week 9
Timed-up-and-go test
Measured: week 21
Secondary outcomes (16)
Berg balance scale
Measured: week 0
Berg balance scale
Measured: week 9
Berg balance scale
Measured: week 21
Activities-specific balance confidence scale
Measured: week 0
Activities-specific balance confidence scale
Measured: week 9
Activities-specific balance confidence scale
Measured: week 21
five times sit-to-stand test
Measured: week 0
five times sit-to-stand test
Measured: week 9
five times sit-to-stand test
Measured: week 21
Mini-Mental State Examination
Measured: week 0
Mini-Mental State Examination
Measured: week 9
Mini-Mental State Examination
Measured: week 21
Quality of Life in Alzheimer's disease
Measured: week 0
Quality of Life in Alzheimer's disease
Measured: week 9
Quality of Life in Alzheimer's disease
Measured: week 21
incidence of falls
Incidence of falls will be recorded by using fall diaries.
Measured: daily starting from week 0 to week 33
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionJan 2015 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Responsible party
- Principal investigator, Marco Yiu-Chung Pang, The Hong Kong Polytechnic University
- Investigators
- Marco Pang, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01734083
- Sponsor's protocol ID
- HSEARS20120929006
- Status last verified
- Nov 2012
- First submitted
- 21 Nov 2012
- Last updated
- 27 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 16372905Bruyere 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.
PubMed 15706558
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Whole Body Vibration Exercise Training on Physical Functioning and Falls in Community-dwelling Elderly With Cognitive Impairments
- ClinicalTrials.gov ID
- NCT01734083
- Acronym / sponsor ID
- HSEARS20120929006
- Conditions
- Dementia
- Keywords
- rehabilitation, exercise, fall, muscle, vibration, mobility, cognition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Study start
- Nov 2012
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 27 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole body vibration exercise | Experimental | Device: Whole body vibration exercise, Behavioral: Conventional exerciseThe 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. |
| Conventional exercise | Active comparator | Behavioral: Conventional exerciseThis group will receive 2 sessions of conventional exercise training per week for a period of 9 weeks. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- significant musculoskeletal conditions (e.g. amputations)
- metal implants in the lower extremity
- recent fracture in the lower extremity
- vestibular disorders
- peripheral vascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole body vibration exerciseThe 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. | Device | Whole body vibration exercise |
| Conventional exerciseThe conventional exercise training will involve a combination of upper limb and lower limb stretching and strengthening exercises, balance training, and gait re-education. | Behavioural | Conventional exercise, Whole body vibration exercise |
Primary outcome
Timed-up-and-go test
Time frame: week 0
A measure of functional mobility
Timed-up-and-go test
Time frame: week 9
Timed-up-and-go test
Time frame: week 21
16 secondary outcomes
Berg balance scale
Time frame: week 0
Berg balance scale
Time frame: week 9
Berg balance scale
Time frame: week 21
Activities-specific balance confidence scale
Time frame: week 0
Activities-specific balance confidence scale
Time frame: week 9
Activities-specific balance confidence scale
Time frame: week 21
five times sit-to-stand test
Time frame: week 0
five times sit-to-stand test
Time frame: week 9
five times sit-to-stand test
Time frame: week 21
Mini-Mental State Examination
Time frame: week 0
Mini-Mental State Examination
Time frame: week 9
Mini-Mental State Examination
Time frame: week 21
Quality of Life in Alzheimer's disease
Time frame: week 0
Quality of Life in Alzheimer's disease
Time frame: week 9
Quality of Life in Alzheimer's disease
Time frame: week 21
incidence of falls
Time frame: daily starting from week 0 to week 33
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2012.
- Background: PubMed 16372905Bautmans 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.
- Background: PubMed 15706558Bruyere 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Pang, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole body vibration exercise and Conventional exercise in people with Dementia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marco Pang, PhD (852-2766-7156, Marco.Pang@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed-up-and-go test (time frame: week 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01734083, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2012.