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Whole Body Vibration Exercise for Elderly With Cognitive Impairments

This study is currently recruiting participants.
Verified November 2012 by The Hong Kong Polytechnic University
Sponsor:
Collaborator:
Chinese University of Hong Kong
Information provided by (Responsible Party):
Marco Yiu-Chung Pang, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:
NCT01734083
First received: November 21, 2012
Last updated: November 26, 2012
Last verified: November 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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:

U.S. FDA Resources

Further study details as provided by The Hong Kong Polytechnic University:

Primary Outcome Measures:
  • Timed-up-and-go test [ Time Frame: week 0 ] [ Designated as safety issue: No ]
    A measure of functional mobility

  • Timed-up-and-go test [ Time Frame: week 9 ] [ Designated as safety issue: No ]
  • Timed-up-and-go test [ Time Frame: week 21 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Berg balance scale [ Time Frame: week 0 ] [ Designated as safety issue: No ]
  • Berg balance scale [ Time Frame: week 9 ] [ Designated as safety issue: No ]
  • Berg balance scale [ Time Frame: week 21 ] [ Designated as safety issue: No ]
  • Activities-specific balance confidence scale [ Time Frame: week 0 ] [ Designated as safety issue: No ]
  • Activities-specific balance confidence scale [ Time Frame: week 9 ] [ Designated as safety issue: No ]
  • Activities-specific balance confidence scale [ Time Frame: week 21 ] [ Designated as safety issue: No ]
  • five times sit-to-stand test [ Time Frame: week 0 ] [ Designated as safety issue: No ]
  • five times sit-to-stand test [ Time Frame: week 9 ] [ Designated as safety issue: No ]
  • five times sit-to-stand test [ Time Frame: week 21 ] [ Designated as safety issue: No ]
  • Mini-Mental State Examination [ Time Frame: week 0 ] [ Designated as safety issue: No ]
  • Mini-Mental State Examination [ Time Frame: week 9 ] [ Designated as safety issue: No ]
  • Mini-Mental State Examination [ Time Frame: week 21 ] [ Designated as safety issue: No ]
  • Quality of Life in Alzheimer's disease [ Time Frame: week 0 ] [ Designated as safety issue: No ]
  • Quality of Life in Alzheimer's disease [ Time Frame: week 9 ] [ Designated as safety issue: No ]
  • Quality of Life in Alzheimer's disease [ Time Frame: week 21 ] [ Designated as safety issue: No ]
  • incidence of falls [ Time Frame: daily starting from week 0 to week 33 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: November 21, 2012
Last Updated: November 26, 2012
Health Authority: Hong Kong: Ethics Committee

Keywords provided by 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
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013