Back to resultsImpact of Whole-body Vibration Training on Sarcopenic Elderly
Primary Purpose
Sarcopenia
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
whole body vibration plus conventional therapy
conventional therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Sarcopenia focused on measuring sarcopenia, vibration, gait, muscle, rehabilitation
Eligibility 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.
Sites / Locations
- Seoul National University Bundang HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Whole body vibration plus conventional therapy group
conventional training group
Arm Description
conventional therapy + whole body vibration training for 40 minutes per day, five days per week for two-week period.
conventional therapy (passive range of motion exercise and walking exercise) for 40 minutes per day, five days per week for two-week period.
Outcomes
Primary Outcome Measures
Berg balance scale
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
Maximal voluntary isometric contraction at knee
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
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
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.
Full Information
NCT ID
NCT03695354
First Posted
October 2, 2018
Last Updated
January 14, 2021
Sponsor
Seoul National University Bundang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03695354
Brief Title
Impact of Whole-body Vibration Training on Sarcopenic Elderly
Official Title
Impact of Whole-body Vibration Training on Sarcopenia in Geriatric Hospitalized Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 8, 2017 (Actual)
Primary Completion Date
May 31, 2021 (Anticipated)
Study Completion Date
July 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
Detailed Description
This study is prospective study.
The goal of this study is
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
sarcopenia, vibration, gait, muscle, rehabilitation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Whole body vibration plus conventional therapy group
Arm Type
Experimental
Arm Description
conventional therapy + whole body vibration training for 40 minutes per day, five days per week for two-week period.
Arm Title
conventional training group
Arm Type
Active Comparator
Arm Description
conventional therapy (passive range of motion exercise and walking exercise) for 40 minutes per day, five days per week for two-week period.
Intervention Type
Device
Intervention Name(s)
whole body vibration plus conventional therapy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
conventional therapy
Intervention Description
conventional physical therapy is consisted of passive range of motion exercise and walking exercise.
Primary Outcome Measure Information:
Title
Berg balance scale
Description
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.
Time Frame
Before intervention / after two weeks intervention
Secondary Outcome Measure Information:
Title
Maximal voluntary isometric contraction at knee
Description
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.
Time Frame
Before intervention / after two weeks intervention
Title
10 meter walking test
Description
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.
Time Frame
Before intervention / after two weeks intervention
Title
Hand grip muscle strength
Description
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.
Time Frame
Before intervention / after two weeks intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jae-Young Lim, Ph.D.
Phone
+821053900373
Email
drlim1@snu.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Bo-Ram Kim
Phone
+82317877732
Email
bboram2@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae-Young Lim, Ph.D.
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
SeongNam
State/Province
Gyeonggi
ZIP/Postal Code
463-707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae-Young Lim, MD, PhD
Phone
+82317877732
Email
jaden.lim@gmail.com
First Name & Middle Initial & Last Name & Degree
Seung-Kyu Lim, MD
Phone
+821096045700
Email
flyingmango77@gmail.com
First Name & Middle Initial & Last Name & Degree
Jae-Young Lim, MD, PhD
First Name & Middle Initial & Last Name & Degree
Seung-Kyu Lim, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20648661
Citation
Verschueren SM, Bogaerts A, Delecluse C, Claessens AL, Haentjens P, Vanderschueren D, Boonen S. The effects of whole-body vibration training and vitamin D supplementation on muscle strength, muscle mass, and bone density in institutionalized elderly women: a 6-month randomized, controlled trial. J Bone Miner Res. 2011 Jan;26(1):42-9. doi: 10.1002/jbmr.181.
Results Reference
background
PubMed Identifier
20546975
Citation
Santin-Medeiros F, Garatachea Vallejo N. [Musculoskeletal effects of vibration training in the elderly]. Rev Esp Geriatr Gerontol. 2010 Sep-Oct;45(5):281-4. doi: 10.1016/j.regg.2010.04.001. Epub 2010 May 23. Spanish.
Results Reference
background
PubMed Identifier
20500555
Citation
von Stengel S, Kemmler W, Engelke K, Kalender WA. Effect of whole-body vibration on neuromuscular performance and body composition for females 65 years and older: a randomized-controlled trial. Scand J Med Sci Sports. 2012 Feb;22(1):119-27. doi: 10.1111/j.1600-0838.2010.01126.x. Epub 2010 May 24.
Results Reference
background
PubMed Identifier
19789832
Citation
Kemmler W, V Stengel S, Mayer S, Niedermayer M, Hentschke C, Kalender WA. [Effect of whole body vibration on the neuromuscular performance of females 65 years and older. One-year results of the controlled randomized ELVIS study]. Z Gerontol Geriatr. 2010 Apr;43(2):125-32. doi: 10.1007/s00391-009-0074-0. Epub 2009 Oct 1. German.
Results Reference
background
PubMed Identifier
19724891
Citation
Pietrangelo T, Mancinelli R, Toniolo L, Cancellara L, Paoli A, Puglielli C, Iodice P, Doria C, Bosco G, D'Amelio L, di Tano G, Fulle S, Saggini R, Fano G, Reggiani C. Effects of local vibrations on skeletal muscle trophism in elderly people: mechanical, cellular, and molecular events. Int J Mol Med. 2009 Oct;24(4):503-12. doi: 10.3892/ijmm_00000259.
Results Reference
background
PubMed Identifier
19422657
Citation
Machado A, Garcia-Lopez D, Gonzalez-Gallego J, Garatachea N. Whole-body vibration training increases muscle strength and mass in older women: a randomized-controlled trial. Scand J Med Sci Sports. 2010 Apr;20(2):200-7. doi: 10.1111/j.1600-0838.2009.00919.x. Epub 2009 Apr 20.
Results Reference
background
PubMed Identifier
18726053
Citation
Kaeding TS. [Sarcopenia and whole body vibration training: an overview]. Z Gerontol Geriatr. 2009 Apr;42(2):88-92. doi: 10.1007/s00391-008-0565-4. Epub 2008 Aug 29. German.
Results Reference
background
PubMed Identifier
17595419
Citation
Bogaerts A, Delecluse C, Claessens AL, Coudyzer W, Boonen S, Verschueren SM. Impact of whole-body vibration training versus fitness training on muscle strength and muscle mass in older men: a 1-year randomized controlled trial. J Gerontol A Biol Sci Med Sci. 2007 Jun;62(6):630-5. doi: 10.1093/gerona/62.6.630.
Results Reference
background
PubMed Identifier
16513017
Citation
Cardinale M, Rittweger J. Vibration exercise makes your muscles and bones stronger: fact or fiction? J Br Menopause Soc. 2006 Mar;12(1):12-8. doi: 10.1258/136218006775997261.
Results Reference
background
PubMed Identifier
16118292
Citation
Cardinale M, Wakeling J. Whole body vibration exercise: are vibrations good for you? Br J Sports Med. 2005 Sep;39(9):585-9; discussion 589. doi: 10.1136/bjsm.2005.016857.
Results Reference
background
PubMed Identifier
14594190
Citation
Cardinale M, Pope MH. The effects of whole body vibration on humans: dangerous or advantageous? Acta Physiol Hung. 2003;90(3):195-206. doi: 10.1556/APhysiol.90.2003.3.2.
Results Reference
background
PubMed Identifier
15161453
Citation
Roelants M, Delecluse C, Verschueren SM. Whole-body-vibration training increases knee-extension strength and speed of movement in older women. J Am Geriatr Soc. 2004 Jun;52(6):901-8. doi: 10.1111/j.1532-5415.2004.52256.x.
Results Reference
background
PubMed Identifier
18048942
Citation
Rees S, Murphy A, Watsford M. Effects of vibration exercise on muscle performance and mobility in an older population. J Aging Phys Act. 2007 Oct;15(4):367-81. doi: 10.1123/japa.15.4.367.
Results Reference
background
PubMed Identifier
18550436
Citation
Rees SS, Murphy AJ, Watsford ML. Effects of whole body vibration on postural steadiness in an older population. J Sci Med Sport. 2009 Jul;12(4):440-4. doi: 10.1016/j.jsams.2008.02.002. Epub 2008 Jun 11.
Results Reference
background
PubMed Identifier
15903391
Citation
Jordan MJ, Norris SR, Smith DJ, Herzog W. Vibration training: an overview of the area, training consequences, and future considerations. J Strength Cond Res. 2005 May;19(2):459-66. doi: 10.1519/13293.1.
Results Reference
background
PubMed Identifier
17601464
Citation
Cheung WH, Mok HW, Qin L, Sze PC, Lee KM, Leung KS. High-frequency whole-body vibration improves balancing ability in elderly women. Arch Phys Med Rehabil. 2007 Jul;88(7):852-7. doi: 10.1016/j.apmr.2007.03.028.
Results Reference
background
PubMed Identifier
22745878
Citation
Song GE, Kim K, Lee DJ, Joo NS. Whole body vibration effects on body composition in the postmenopausal korean obese women: pilot study. Korean J Fam Med. 2011 Nov;32(7):399-405. doi: 10.4082/kjfm.2011.32.7.399. Epub 2011 Nov 30.
Results Reference
background
PubMed Identifier
24020031
Citation
Park YG, Kwon BS, Park JW, Cha DY, Nam KY, Sim KB, Chang J, Lee HJ. Therapeutic effect of whole body vibration on chronic knee osteoarthritis. Ann Rehabil Med. 2013 Aug;37(4):505-15. doi: 10.5535/arm.2013.37.4.505. Epub 2013 Aug 26.
Results Reference
background
PubMed Identifier
23411791
Citation
Lee BK, Chon SC. Effect of whole body vibration training on mobility in children with cerebral palsy: a randomized controlled experimenter-blinded study. Clin Rehabil. 2013 Jul;27(7):599-607. doi: 10.1177/0269215512470673. Epub 2013 Feb 14.
Results Reference
background
PubMed Identifier
24679831
Citation
Smoliner C, Sieber CC, Wirth R. Prevalence of sarcopenia in geriatric hospitalized patients. J Am Med Dir Assoc. 2014 Apr;15(4):267-72. doi: 10.1016/j.jamda.2013.11.027.
Results Reference
background
PubMed Identifier
23384705
Citation
Patel HP, Syddall HE, Jameson K, Robinson S, Denison H, Roberts HC, Edwards M, Dennison E, Cooper C, Aihie Sayer A. Prevalence of sarcopenia in community-dwelling older people in the UK using the European Working Group on Sarcopenia in Older People (EWGSOP) definition: findings from the Hertfordshire Cohort Study (HCS). Age Ageing. 2013 May;42(3):378-84. doi: 10.1093/ageing/afs197. Epub 2013 Feb 5.
Results Reference
background
PubMed Identifier
21483221
Citation
Kim IH. Age and gender differences in the relation of chronic diseases to activity of daily living (ADL) disability for elderly South Koreans: based on representative data. J Prev Med Public Health. 2011 Jan;44(1):32-40. doi: 10.3961/jpmph.2011.44.1.32.
Results Reference
background
Learn more about this trial
Impact of Whole-body Vibration Training on Sarcopenic Elderly
We'll reach out to this number within 24 hrs