Effect of Whole Body Vibration on Walking Performance in Elderly Hemodialysis Patients

September 19, 2022 updated by: Yusuke Sakaguchi, Osaka University

A Randomized Controlled Trial to Evaluate the Efficacy of Whole Body Vibration on Walking Performance in Elderly Hemodialysis Patients

The purpose of this study is to evaluate the efficacy of whole body vibration for 12 weeks on walking performance in elderly hemodialysis patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a multicenter, prospective, randomized controlled trial. Eligible subjects will be randomized in a 1:1 ratio to a whole-body vibration (WBV) group or controlled group. Patients in a WBV group will receive WBV training three times a week before initiation of dialysis sessions for 12 weeks. The primary outcome of the study will be the change in walking performance assessed by the timed up and go test.

Study Type

Interventional

Enrollment (Actual)

98

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 Locations

  • Japan
    • Osaka
      • Suita, Osaka, Japan, 5650871
        • Osaka University Hospital

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

61 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Undergoing maintenance hemodialysis three times a week .

Exclusion Criteria:

  • Having difficulty in walking by oneself.
  • Having difficulty in receiving whole body vibration training because of cognitive impairment.
  • History of fracture of lower limb within 1 year.
  • History of total hip arthroplasty.
  • Unsuitable for participant in the trial by an attending physician.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Whole Body Vibration
Other: Whole Body Vibration
Receiving WBV training three times a week before initiation of dialysis sessions for 12 weeks. Subjects stand on a platform of WBV for 3 minutes in every training session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in the timed up and go test
Time Frame: 12 weeks after starting intervention
12 weeks after starting intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in the one-leg standing test
Time Frame: 12 weeks after starting intervention
12 weeks after starting intervention
Change in the 30-second chair-stand test
Time Frame: 12 weeks after starting intervention
12 weeks after starting intervention

Collaborators and Investigators

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

Sponsor

Osaka University

Investigators

  • Principal Investigator: Yusuke Sakaguchi, MD, PhD, Department of Nephrology, Osaka University

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 (Actual)

April 1, 2021

Primary Completion (Actual)

March 30, 2022

Study Completion (Actual)

March 30, 2022

Study Registration Dates

First Submitted

February 24, 2021

First Submitted That Met QC Criteria

February 24, 2021

First Posted (Actual)

March 1, 2021

Study Record Updates

Last Update Posted (Actual)

September 21, 2022

Last Update Submitted That Met QC Criteria

September 19, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • WBV-HD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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