Effects of Whole-body Vibration in the Frail Elderly

March 16, 2014 updated by: Li Zhang

Acute and Chronic Effects of Whole-body Vibration on Mobility, Muscle Strength, Bone and General Health Status in the Frail Elderly

Objective: To study the acute and chronic effects of whole-body vibration (WBV) exercises on the lower extremity blood flow, mobility function, balance, muscle strength, bone density, and general health status, and its feasibility as an intervention in frail elderly patients.

Design: Randomized controlled trial. Subjects: The frail older persons meeting the Fried Frailty Criteria.

Interventions: All eligible subjects were randomly assigned to 4 groups:

(1) WBV group: Subjects received a whole-body vibration exercise alone; (2) Progressive resistance training (PRT) group: Subjects received progressive resistance training; (3) WBV+ PRT group: Subjects received the whole-body vibration and progressive resistance training; (4) Control group: Subjects received no intervention/training. The periods of intervention are 12 weeks.

Main measures: The lower extremities blood flow (the diameters and red blood cell velocity of the common femoral artery), timed up and go test, 30-second chair stand test, five times sit to stand test, lower extremities muscle strength, balance function, balance confidence, bone density, and general health status was assessed at the beginning of the study, at instant, 12 weeks and 24 month after the intervention.

Study hypothesis: Whole-body vibration exercise is a safe and effective method that can improve the lower extremity blood flow, mobility function, balance, muscle strength, bone density, and general health status in the frail elderly.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Recruiting
        • Rehabilitation Department, Nanlou, Chinese PLA general hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ≥75 years old
  • Fried Frailty Criteria
  • Mini Mental State Examination score ≥18

Exclusion Criteria:

  • Recent fractures (≤6 months)
  • Gallbladder or kidney stones
  • Malignancies
  • Rheumatic arthritis
  • Epilepsy
  • Serious heart sicknesses or an implant, and bypass stent or cardiac pacemaker
  • Any diseases to be associated with a life expectancy of less than 12 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: WBV training
Whole-body vibration training was performed on a commercial Galileo machine (Germany). Participants were required to stand on the moveable rectangular platform and positioned their feet at an equal and standardized distance from the axis of rotation so that the vertical vibration amplitude was 1-3 mm. The frequency was set at 6-26 Hz. The vibration protocol consisted of four to five bouts (60 seconds for each bout), and three to five times a week for 12 weeks. The positions taken by the subjects differed according to their function. Participants who could stand independently were instructed to adopt a "partial squat" position with slight flexion at the hips, knees, and ankle joints to damp the vibrations approximately at the pelvic level.
Procedure: WBV training
EXPERIMENTAL: WBV+ PRT training
Procedure: WBV training
Procedure: PRT training
ACTIVE_COMPARATOR: PRT training
Procedure: PRT training
PLACEBO_COMPARATOR: Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of the common femoral artery's blood flow from Baseline to 60min post-WBV
Time Frame: 60min post-WBV
60min post-WBV
Change of lower extremities muscle strength from Baseline to 3 month post-WBV
Time Frame: 3 month post-WBV
3 month post-WBV
Change of "timed up and go" test (TUGT) from Baseline to 3 month post-WBV
Time Frame: 3 month post-WBV
3 month post-WBV
Change of 30-second chair stand test from Baseline to 3 month post-WBV
Time Frame: 3 month post-WBV
3 month post-WBV
Change of balance function from Baseline to 3 month post-WBV
Time Frame: 3 month post-WBV
3 month post-WBV
Change of balance confidence from Baseline to 3 month post-WBV
Time Frame: 3 month post-WBV
3 month post-WBV
Change of bone density from Baseline to 6 month post-WBV
Time Frame: 6 month post-WBV
6 month post-WBV
Change of general health status (SF-12 score) from Baseline to 6 month post-WBV
Time Frame: 6 month post-WBV
6 month post-WBV

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Li Zhang

Investigators

  • Study Director: Changshui Weng, Bachelor, Chinese PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ANTICIPATED)

December 1, 2015

Study Completion (ANTICIPATED)

December 1, 2015

Study Registration Dates

First Submitted

March 14, 2014

First Submitted That Met QC Criteria

March 16, 2014

First Posted (ESTIMATE)

March 18, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

March 18, 2014

Last Update Submitted That Met QC Criteria

March 16, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ChinaPLAGH-2013FC3009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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