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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Marco Pang, PhD contact

852-2766-7156

Marco.Pang@polyu.edu.hk

Hong Kong1 site, 1 recruiting

  • Jockey Club Centre for Positive Ageing

    Shatin, New Territories

    Timothy Kwok, MD, 852-2636-6323, tkwok@cuhk.edu.hk

    Timothy Kwok, MD

    Recruiting

Other trials in Hong Kong

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 groups in NCT01734083
Study groupRoleWhat they receive
Whole body vibration exerciseExperimentalThe 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 exerciseActive comparatorThis 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.

  1. Timed-up-and-go test

    A measure of functional mobility

    Measured: week 0

  2. Timed-up-and-go test

    Measured: week 9

  3. Timed-up-and-go test

    Measured: week 21

Secondary outcomes (16)

  1. Berg balance scale

    Measured: week 0

  2. Berg balance scale

    Measured: week 9

  3. Berg balance scale

    Measured: week 21

  4. Activities-specific balance confidence scale

    Measured: week 0

  5. Activities-specific balance confidence scale

    Measured: week 9

  6. Activities-specific balance confidence scale

    Measured: week 21

  7. five times sit-to-stand test

    Measured: week 0

  8. five times sit-to-stand test

    Measured: week 9

  9. five times sit-to-stand test

    Measured: week 21

  10. Mini-Mental State Examination

    Measured: week 0

  11. Mini-Mental State Examination

    Measured: week 9

  12. Mini-Mental State Examination

    Measured: week 21

  13. Quality of Life in Alzheimer's disease

    Measured: week 0

  14. Quality of Life in Alzheimer's disease

    Measured: week 9

  15. Quality of Life in Alzheimer's disease

    Measured: week 21

  16. 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.

  1. First posted27 Nov 2012 (estimated)
  2. Study startNov 2012
  3. Primary completionJan 2015 (estimated)
  4. Study completionJul 2015 (estimated)

Resources

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)
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 16372905

  • 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.

    PubMed 15706558

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.

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