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Whole Body Vibration Exercise for Elderly With Cognitive Impairments

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ClinicalTrials.gov Identifier: NCT01734083
Recruitment Status : Unknown
Verified November 2012 by Marco Yiu-Chung Pang, The Hong Kong Polytechnic University.
Recruitment status was:  Recruiting
First Posted : November 27, 2012
Last Update Posted : November 27, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Dementia Device: Whole body vibration exercise Behavioral: Conventional exercise

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Whole Body Vibration Exercise Training on Physical Functioning and Falls in Community-dwelling Elderly With Cognitive Impairments
Study Start Date : November 2012
Estimated Primary Completion Date : January 2015
Estimated Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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.
Device: Whole body vibration exercise
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.
Behavioral: Conventional exercise
The conventional exercise training will involve a combination of upper limb and lower limb stretching and strengthening exercises, balance training, and gait re-education.
Active Comparator: Conventional exercise
This group will receive 2 sessions of conventional exercise training per week for a period of 9 weeks.
Behavioral: Conventional exercise
The conventional exercise training will involve a combination of upper limb and lower limb stretching and strengthening exercises, balance training, and gait re-education.


Outcome Measures

Primary Outcome Measures :
  1. Timed-up-and-go test [ Time Frame: week 0 ]
    A measure of functional mobility

  2. Timed-up-and-go test [ Time Frame: week 9 ]
  3. Timed-up-and-go test [ Time Frame: week 21 ]

Secondary Outcome Measures :
  1. Berg balance scale [ Time Frame: week 0 ]
  2. Berg balance scale [ Time Frame: week 9 ]
  3. Berg balance scale [ Time Frame: week 21 ]
  4. Activities-specific balance confidence scale [ Time Frame: week 0 ]
  5. Activities-specific balance confidence scale [ Time Frame: week 9 ]
  6. Activities-specific balance confidence scale [ Time Frame: week 21 ]
  7. five times sit-to-stand test [ Time Frame: week 0 ]
  8. five times sit-to-stand test [ Time Frame: week 9 ]
  9. five times sit-to-stand test [ Time Frame: week 21 ]
  10. Mini-Mental State Examination [ Time Frame: week 0 ]
  11. Mini-Mental State Examination [ Time Frame: week 9 ]
  12. Mini-Mental State Examination [ Time Frame: week 21 ]
  13. Quality of Life in Alzheimer's disease [ Time Frame: week 0 ]
  14. Quality of Life in Alzheimer's disease [ Time Frame: week 9 ]
  15. Quality of Life in Alzheimer's disease [ Time Frame: week 21 ]
  16. incidence of falls [ Time Frame: daily starting from week 0 to week 33 ]
    Incidence of falls will be recorded by using fall diaries.


Eligibility Criteria

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01734083


Contacts
Contact: Marco Pang, PhD 852-2766-7156 Marco.Pang@polyu.edu.hk

Locations
Hong Kong
Jockey Club Centre for Positive Ageing Recruiting
Shatin, New Territories, Hong Kong
Contact: Timothy Kwok, MD    852-2636-6323    tkwok@cuhk.edu.hk   
Principal Investigator: Timothy Kwok, MD         
Sponsors and Collaborators
The Hong Kong Polytechnic University
Chinese University of Hong Kong
Investigators
Principal Investigator: Marco Pang, PhD Hong Kong Polytechnic University
More Information

Publications:
Responsible Party: Marco Yiu-Chung Pang, Associate Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT01734083     History of Changes
Other Study ID Numbers: HSEARS20120929006
First Posted: November 27, 2012    Key Record Dates
Last Update Posted: November 27, 2012
Last Verified: November 2012

Keywords provided by Marco Yiu-Chung Pang, The Hong Kong Polytechnic University:
rehabilitation
exercise
fall
muscle
vibration
mobility
cognition

Additional relevant MeSH terms:
Dementia
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders