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Whole Body Vibration Exercise for Elderly With Cognitive Impairments

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2012 by Marco Yiu-Chung Pang, The Hong Kong Polytechnic University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01734083
First Posted: November 27, 2012
Last Update Posted: November 28, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Chinese University of Hong Kong
Information provided by (Responsible Party):
Marco Yiu-Chung Pang, The Hong Kong Polytechnic University
  Purpose
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 Intervention
Dementia Device: Whole body vibration exercise Behavioral: Conventional exercise

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Marco Yiu-Chung Pang, The Hong Kong Polytechnic University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]
    Incidence of falls will be recorded by using fall diaries.


Estimated Enrollment: 66
Study Start Date: November 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

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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 Submitted: November 21, 2012
First Posted: November 27, 2012
Last Update Posted: November 28, 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
Cognition Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders