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Whole Body Vibration Exercise for Elderly With Cognitive Impairments

This study is currently recruiting participants. (see Contacts and Locations)
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on November 25, 2014