NCT03695354

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 8, 2017

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 2, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 4, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

January 15, 2021

Status Verified

January 1, 2021

Enrollment Period

4.3 years

First QC Date

October 2, 2018

Last Update Submit

January 14, 2021

Conditions

Keywords

sarcopeniavibrationgaitmusclerehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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.

    Before intervention / after two weeks intervention

Secondary Outcomes (3)

  • Maximal voluntary isometric contraction at knee

    Before intervention / after two weeks intervention

  • 10 meter walking test

    Before intervention / after two weeks intervention

  • Hand grip muscle strength

    Before intervention / after two weeks intervention

Study Arms (2)

Whole body vibration plus conventional therapy group

EXPERIMENTAL

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

conventional training group

ACTIVE COMPARATOR

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

Interventions

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.

Whole body vibration plus conventional therapy group

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

conventional training group

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

RECRUITING

Related Publications (22)

  • 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.

    PMID: 20648661BACKGROUND
  • 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.

    PMID: 20546975BACKGROUND
  • 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.

    PMID: 20500555BACKGROUND
  • 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.

    PMID: 19789832BACKGROUND
  • 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.

    PMID: 19724891BACKGROUND
  • 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.

    PMID: 19422657BACKGROUND
  • 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.

    PMID: 18726053BACKGROUND
  • 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.

    PMID: 17595419BACKGROUND
  • 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.

    PMID: 16513017BACKGROUND
  • 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.

    PMID: 16118292BACKGROUND
  • 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.

    PMID: 14594190BACKGROUND
  • 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.

    PMID: 15161453BACKGROUND
  • 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.

    PMID: 18048942BACKGROUND
  • 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.

    PMID: 18550436BACKGROUND
  • 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.

    PMID: 15903391BACKGROUND
  • 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.

    PMID: 17601464BACKGROUND
  • 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.

    PMID: 22745878BACKGROUND
  • 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.

    PMID: 24020031BACKGROUND
  • 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.

    PMID: 23411791BACKGROUND
  • 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.

    PMID: 24679831BACKGROUND
  • 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.

    PMID: 23384705BACKGROUND
  • 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.

    PMID: 21483221BACKGROUND

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Jae-Young Lim, Ph.D.

    Seoul National University Bundang Hospital

    STUDY DIRECTOR

Central Study Contacts

Jae-Young Lim, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Rehabilitation Medicine

Study Record Dates

First Submitted

October 2, 2018

First Posted

October 4, 2018

Study Start

February 8, 2017

Primary Completion

May 31, 2021

Study Completion

July 31, 2021

Last Updated

January 15, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations