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Impact of Whole-body Vibration Training on Sarcopenic Elderly

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03695354
Recruitment Status : Recruiting
First Posted : October 4, 2018
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Jae-Young Lim, Seoul National University Bundang Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Sarcopenia Device: whole body vibration plus conventional therapy Procedure: conventional therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Impact of Whole-body Vibration Training on Sarcopenia in Geriatric Hospitalized Patients
Actual Study Start Date : February 8, 2017
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : December 31, 2019

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.




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.




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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03695354


Contacts
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Contact: Jae-Young Lim, Ph.D. +821053900373 drlim1@snu.ac.kr
Contact: Bo-Ram Kim +82317877732 bboram2@gmail.com

Locations
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Korea, Republic of
Seoul National University Bundang Hospital Recruiting
SeongNam, Gyeonggi, Korea, Republic of, 463-707
Contact: Jae-Young Lim, MD, PhD    +82317877732    jaden.lim@gmail.com   
Contact: Seung-Kyu Lim, MD    +821096045700    flyingmango77@gmail.com   
Principal Investigator: Jae-Young Lim, MD, PhD         
Sub-Investigator: Seung-Kyu Lim, MD         
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
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Study Director: Jae-Young Lim, Ph.D. Seoul National University Bundang Hospital
Publications:

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Responsible Party: Jae-Young Lim, Professor, Department of Rehabilitation Medicine, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT03695354    
Other Study ID Numbers: B1607354003
First Posted: October 4, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jae-Young Lim, Seoul National University Bundang Hospital:
sarcopenia
vibration
gait
muscle
rehabilitation
Additional relevant MeSH terms:
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Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical