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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03695354
Other study ID # B1607354003
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 8, 2017
Est. completion date July 31, 2021

Study information

Verified date January 2021
Source Seoul National University Bundang Hospital
Contact Jae-Young Lim, Ph.D.
Phone +821053900373
Email drlim1@snu.ac.kr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date July 31, 2021
Est. primary completion date May 31, 2021
Accepts healthy volunteers No
Gender All
Age group 70 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Korea, Republic of Seoul National University Bundang Hospital SeongNam Gyeonggi

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (22)

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. — View Citation

Cardinale M, Pope MH. The effects of whole body vibration on humans: dangerous or advantageous? Acta Physiol Hung. 2003;90(3):195-206. Review. — View 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. Review. — View 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. Review. — View 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. — View 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. Review. — View 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. Review. German. — View 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. — View 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. — View 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. — View Citation

Machado A, García-López D, González-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. — View 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. — View 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. — View 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, Fanò 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. — View 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. — View 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. — View 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. — View 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. Review. Spanish. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 22 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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.
Before intervention / after two weeks intervention
Secondary 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.
Before intervention / after two weeks intervention
Secondary 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.
Before intervention / after two weeks intervention
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