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Whole Body Vibration Exercise Training for Institutionalized Elderly

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ClinicalTrials.gov Identifier: NCT01735682
Recruitment Status : Unknown
Verified May 2014 by Marco Yiu-Chung Pang, The Hong Kong Polytechnic University.
Recruitment status was:  Recruiting
First Posted : November 28, 2012
Last Update Posted : May 30, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
It is hypothesized that whole body vibration exercise group will have significantly more improvement in physical functioning and reduction in fall incidence among institutionalized elderly, compared with conventional exercise group and control group.

Condition or disease Intervention/treatment
Geriatric Disorder Device: Whole body vibration Behavioral: Conventional exercise Behavioral: Control

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 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 Institutionalized Elderly: a Randomized Controlled Trial
Study Start Date : November 2012
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Whole body vibration
This group will receive whole body vibration and conventional exercise training (1 hour per session, 3 sessions per week, for 8 consecutive weeks).
Device: Whole body vibration
The vibration frequency and amplitude used will be 30-40 Hz and 1mm, respectively. The total exposure to the vibration stimulation is 4 minutes.
Active Comparator: Conventional exercise
This group will receive convention exercise training (1 hour per session, 3 sessions per week, for 8 consecutive weeks).
Behavioral: Conventional exercise
The conventional exercise training involves upper limb and lower limb strengthening exercises using sandbags.
Active Comparator: Control
This group will have exercise training that involve only the upper limbs (about 30 minutes per session, 3 sessions per week, for 8 consecutive weeks).
Behavioral: Control
The control treatment involves exercises of the upper limbs.


Outcome Measures

Primary Outcome Measures :
  1. Timed-Up-and-Go test [ Time Frame: week 0 ]
    It is a measure of functional mobility

  2. Timed-up-and-go test [ Time Frame: week 8 ]

Secondary Outcome Measures :
  1. Berg balance scale [ Time Frame: week 0 ]
  2. Berg balance scale [ Time Frame: week 8 ]
  3. leg extension strength [ Time Frame: week 0 ]
  4. leg extension strength [ Time Frame: week 8 ]
  5. shoulder abduction strength [ Time Frame: week 0 ]
  6. shoulder abduction strength [ Time Frame: week 8 ]
  7. elbow flexion strength [ Time Frame: week 0 ]
  8. elbow flexion strength [ Time Frame: week 8 ]
  9. six minute walk test [ Time Frame: week 0 ]
  10. six minute walk test [ Time Frame: week 8 ]
  11. Activities-specific balance confidence scale [ Time Frame: week 0 ]
  12. Activities-specific balance confidence scale [ Time Frame: week 8 ]
  13. Quick DASH [ Time Frame: week 0 ]
    A measure of upper limb function

  14. Quick DASH [ Time Frame: week 8 ]
  15. Physiological Profile Assessment: short form [ Time Frame: week 0 ]
  16. Physiological Profile Assessment: short form [ Time Frame: week 8 ]
  17. falls incidence [ Time Frame: Daily from week 0 to 12 months after termination of treatment/control period ]

Eligibility Criteria

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Functional Ambulation Category 1 to 4
  • able to understand simple verbal commands
  • able to tolerate intermittent physical activity for at least 45 minutes
  • able to perform knee flexion >45 degree
  • able to stand with or without support for 1 minute or more

Exclusion Criteria:

  • peripheral vascular disease
  • any symptoms associated with vestibular disorder
  • any contraindications to exercise (e.g. unstable angina)
  • any serious illnesses that preclude participation (e.g. cancer)
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): NCT01735682


Contacts
Contact: Philip Chan, MSc 852-9851-1382 cfl083@gmail.com

Locations
Hong Kong
Shatin Hospital Recruiting
Shatin, New Territories, Hong Kong
Contact: Philip Chan, MSc    852-9851-1382    cfl083@gmail.com   
Sponsors and Collaborators
The Hong Kong Polytechnic University
Shatin Hospital
Investigators
Principal Investigator: Marco Pang, PhD Hong Kong Polytechnic University
More Information

Publications:
Responsible Party: Marco Yiu-Chung Pang, Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT01735682     History of Changes
Other Study ID Numbers: HSEARS20120730001
First Posted: November 28, 2012    Key Record Dates
Last Update Posted: May 30, 2014
Last Verified: May 2014

Keywords provided by Marco Yiu-Chung Pang, The Hong Kong Polytechnic University:
older adults
exercise
balance
gait
fall
rehabilitation
vibration
muscle