Impact of Whole-body Vibration Training on Sarcopenic Elderly

January 14, 2021 updated by: Jae-Young Lim, Seoul National University Bundang Hospital

Impact of Whole-body Vibration Training on Sarcopenia in Geriatric Hospitalized Patients

Sarcopenia is defined as a phenomenon which the amount of muscle mass in elderly aged 60-70 years is about 20-30% lower than that of the young adults and middle-aged people due to muscle atrophy caused by aging and alteration in muscle itself in aged skeletal muscle. Whole body vibration(WBV) training can be a choice for hospitalized patients who cannot conduct high intensity resistance training.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study is prospective study.

The goal of this study is

  1. To investigate the effect of whole body vibration training using vibration platform with tilt table on muscle mass, muscle strength, physical performance in hospitalized older adults with sarcopenia.
  2. To demonstrate whether whole body vibration training using vibration platform with tilt table can be useful in hospitalized older adults with sarcopenia who could not perform high intensity exercise.

Study Type

Interventional

Enrollment (Anticipated)

40

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

  • Korea, Republic of
    • Gyeonggi
      • SeongNam, Gyeonggi, Korea, Republic of, 463-707
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jae-Young Lim, MD, PhD
        • Sub-Investigator:
          • Seung-Kyu Lim, MD

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

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • More than 70-year old people who admitted Seoul National University hospital, Bundang.
  • Deconditioning subjects with diabetics, infections, chronic lung disease, etc. who cannot walk independently due to long-term hospital care.
  • Subjects who had a mobility impairment.
  • Subjects who can agree voluntarily.

Exclusion Criteria:

  • Subjects who inserted implant due to trauma within 1~2 months recently.
  • Acute coronary syndrome.
  • Uncontrolled hypertension.
  • Subjects who took drugs which can affects neuromuscular system.
  • Severely impaired cognition
  • Subjects who cannot agree volun.tarily.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Whole body vibration plus conventional therapy group
conventional therapy + whole body vibration training for 40 minutes per day, five days per week for two-week period.
Device: whole body vibration plus conventional therapy

Subjects enrolled in whole body vibration training group are exposed to side-to-side alternating vertical sinusoidal vibration. Galileo system(Novotec Medical GmbH, Pforzheim, Germany) is used to training. Frequency of whole body vibration is 12Hz and amplitude is 4mm. After 10 minutes of vibration training, subjects rest 3 minutes. Then, additional 10 minutes of training will be given.

conventional physical therapy is consisted of passive range of motion exercise and walking exercise.
Active Comparator: conventional training group
conventional therapy (passive range of motion exercise and walking exercise) for 40 minutes per day, five days per week for two-week period.
Procedure: conventional therapy
conventional physical therapy is consisted of passive range of motion exercise and walking exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Berg balance scale
Time Frame: Before intervention / after two weeks intervention

Change from baseline Berg balance scale to 2 weeks after initial assessment.

Berg balance scale [from 0 to 56 score] is widely used to assess subjects' ability to control body balance.

For '0' score, it means subject cannot maintain his/her own standing balance. For '56' score, he/she can properly keep static/dynamic standing balance.
Before intervention / after two weeks intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximal voluntary isometric contraction at knee
Time Frame: Before intervention / after two weeks intervention

Change from baseline knee extension power to 2 weeks after initial assessment.

Using the machine(muscle tester(manual), Lafayett instrument, USA), knee extension power will be measured while subject sit in the chair.
Before intervention / after two weeks intervention
10 meter walking test
Time Frame: Before intervention / after two weeks intervention

Change from baseline time when performing 10 meter walking test to 2 weeks after initial assessment.

The subject was asked to move 10 meter away from baseline. While subject moved, total amount of time was measured. Then, the time used in first 2 meter movement and last time used in last 2 meter movement was excluded. Finally, total time used in 6 meter movement was measured.
Before intervention / after two weeks intervention
Hand grip muscle strength
Time Frame: Before intervention / after two weeks intervention

Change from baseline hand grip strength to 2 weeks after initial assessment.

Its assessment is made by Leonardo Mechanograph(Novotec Medical GmbH, Pforzheim, Germany), (unit = N ). For the actual testing procedure, grip strength measurements of the bilateral limb were conducted. The subject was instructed to slowly squeeze the machine. Each measure site was tested one times during 3 seconds. The subjects sit in the chair, maintaining elbow flexed at 90 degree.
Before intervention / after two weeks intervention

Collaborators and Investigators

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

Sponsor

Seoul National University Bundang Hospital

Investigators

  • Study Director: Jae-Young Lim, Ph.D., Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 8, 2017

Primary Completion (Anticipated)

May 31, 2021

Study Completion (Anticipated)

July 31, 2021

Study Registration Dates

First Submitted

October 2, 2018

First Submitted That Met QC Criteria

October 2, 2018

First Posted (Actual)

October 4, 2018

Study Record Updates

Last Update Posted (Actual)

January 15, 2021

Last Update Submitted That Met QC Criteria

January 14, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B1607354003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

Clinical Trials on Sarcopenia

Clinical Trials on whole body vibration plus conventional therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe