Whole Body Vibration Exercise Training for Institutionalized Elderly

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by The Hong Kong Polytechnic University
Sponsor:
Collaborator:
Shatin Hospital, Hong Kong
Information provided by (Responsible Party):
Marco Yiu-Chung Pang, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:
NCT01735682
First received: November 20, 2012
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

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 Intervention
Geriatric Disorder
Device: Whole body vibration
Behavioral: Conventional exercise
Behavioral: Control

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 Institutionalized Elderly: a Randomized Controlled Trial

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 ]
    It is a measure of functional mobility

  • Timed-up-and-go test [ Time Frame: week 8 ] [ 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 8 ] [ Designated as safety issue: No ]
  • leg extension strength [ Time Frame: week 0 ] [ Designated as safety issue: No ]
  • leg extension strength [ Time Frame: week 8 ] [ Designated as safety issue: No ]
  • shoulder abduction strength [ Time Frame: week 0 ] [ Designated as safety issue: No ]
  • shoulder abduction strength [ Time Frame: week 8 ] [ Designated as safety issue: No ]
  • elbow flexion strength [ Time Frame: week 0 ] [ Designated as safety issue: No ]
  • elbow flexion strength [ Time Frame: week 8 ] [ Designated as safety issue: No ]
  • six minute walk test [ Time Frame: week 0 ] [ Designated as safety issue: No ]
  • six minute walk test [ Time Frame: week 8 ] [ 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 8 ] [ Designated as safety issue: No ]
  • Quick DASH [ Time Frame: week 0 ] [ Designated as safety issue: No ]
    A measure of upper limb function

  • Quick DASH [ Time Frame: week 8 ] [ Designated as safety issue: No ]
  • Physiological Profile Assessment: short form [ Time Frame: week 0 ] [ Designated as safety issue: No ]
  • Physiological Profile Assessment: short form [ Time Frame: week 8 ] [ Designated as safety issue: No ]
  • falls incidence [ Time Frame: Daily from week 0 to 12 months after termination of treatment/control period ] [ Designated as safety issue: No ]

Estimated Enrollment: 68
Study Start Date: November 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
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: 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, Hong Kong
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
Study First Received: November 20, 2012
Last Updated: May 29, 2014
Health Authority: Hong Kong: Research Office, The Hong Kong Polytechnic University

Keywords provided by The Hong Kong Polytechnic University:
older adults
exercise
balance
gait
fall
rehabilitation
vibration
muscle

ClinicalTrials.gov processed this record on July 22, 2014