Impact of Whole-body Vibration Training on Sarcopenic Elderly

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Jae-Young Lim，Seoul National University Bundang Hospital

Tracking Information

First Submitted Date ^ICMJE

October 2, 2018

First Posted Date ^ICMJE

October 4, 2018

Last Update Posted Date

October 4, 2018

Actual Study Start Date ^ICMJE

February 8, 2017

Estimated Primary Completion Date

December 31, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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.
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.
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.

Descriptive Information

Brief Title ^ICMJE

Impact of Whole-body Vibration Training on Sarcopenic Elderly

Official Title ^ICMJE

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

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.

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 ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Supportive Care

Condition ^ICMJE

Intervention ^ICMJE

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.
Procedure: conventional therapy
conventional physical therapy is consisted of passive range of motion exercise and walking exercise.

Study Arms

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.
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.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

December 31, 2018

Estimated Primary Completion Date

December 31, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

70 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Korea, Republic of

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Jae-Young Lim，Seoul National University Bundang Hospital

Study Sponsor ^ICMJE

Seoul National University Bundang Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

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

PRS Account

Seoul National University Bundang Hospital

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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