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Impact of Whole-body Vibration Training on Sarcopenic Elderly

Sponsor
Seoul National University Bundang Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03695354
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
53.7
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: whole body vibration plus conventional therapy
  • Procedure: conventional therapy
 N/A

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 Design

Study Type:
Interventional
Anticipated 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 :
Feb 8, 2017
Anticipated Primary Completion Date :
May 31, 2021
Anticipated Study Completion Date :
Jul 31, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Berg balance scale [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
70 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul National University Bundang Hospital SeongNam Gyeonggi Korea, Republic of 463-707

Sponsors and Collaborators

  • Seoul National University Bundang Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

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:
Oct 4, 2018
Last Update Posted:
Jan 15, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jae-Young Lim, Professor, Department of Rehabilitation Medicine, Seoul National University Bundang Hospital
sarcopenia
vibration
gait
muscle
rehabilitation
Additional relevant MeSH terms:
Sarcopenia

Study Results

No Results Posted as of Jan 15, 2021