SarcopeniaNCT03695354
Impact of Whole-body Vibration Training on Sarcopenic Elderly
A study testing whole body vibration plus conventional therapy and conventional therapy in people with Sarcopenia, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Sarcopenia
- What is being tested?
- whole body vibration plus conventional therapy and conventional therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Feb 2017to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
Jae-Young Lim, MD, PhD, +82317877732, jaden.lim@gmail.com
Seung-Kyu Lim, MD, +821096045700, flyingmango77@gmail.com
About this study
Official title: Impact of Whole-body Vibration Training on Sarcopenia in Geriatric Hospitalized Patients
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.
Read the 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.
- Conditions
- Sarcopenia
- Being tested
- whole body vibration plus conventional therapy, conventional therapy
- Keywords
- sarcopenia, vibration, gait, muscle, rehabilitation
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole body vibration plus conventional therapyDevice
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.
conventional therapyProcedure or surgery
conventional physical therapy is consisted of passive range of motion exercise and walking exercise.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before intervention / after two weeks intervention
Secondary outcomes (3)
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.
Measured: Before intervention / after two weeks intervention
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.
Measured: Before intervention / after two weeks intervention
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.
Measured: Before intervention / after two weeks intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start8 Feb 2017
- Primary completion31 May 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae-Young Lim, Seoul National University Bundang Hospital
- Investigators
- Jae-Young Lim, Ph.D., Study director, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03695354
- Sponsor's protocol ID
- B1607354003
- Status last verified
- Jan 2021
- First submitted
- 2 Oct 2018
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20648661Santin-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.
PubMed 20546975von 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.
PubMed 20500555Kemmler 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.
PubMed 19789832Pietrangelo 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.
PubMed 19724891Machado 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.
PubMed 19422657Kaeding 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.
PubMed 18726053Bogaerts 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.
PubMed 17595419Cardinale 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.
PubMed 16513017Cardinale 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.
PubMed 16118292Cardinale 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.
PubMed 14594190Roelants 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.
PubMed 15161453Rees 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.
PubMed 18048942Rees 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.
PubMed 18550436Jordan 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.
PubMed 15903391
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Whole-body Vibration Training on Sarcopenia in Geriatric Hospitalized Patients
- ClinicalTrials.gov ID
- NCT03695354
- Acronym / sponsor ID
- B1607354003
- Conditions
- Sarcopenia
- Keywords
- sarcopenia, vibration, gait, muscle, rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 8 Feb 2017 (actual)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 4 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole body vibration plus conventional therapy group | Experimental | Device: whole body vibration plus conventional therapyconventional therapy + whole body vibration training for 40 minutes per day, five days per week for two-week period. |
| conventional training group | Active comparator | Procedure: conventional therapyconventional therapy (passive range of motion exercise and walking exercise) for 40 minutes per day, five days per week for two-week period. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| whole body vibration plus conventional therapySubjects 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. | Device | Whole body vibration plus conventional therapy group |
| conventional therapyconventional physical therapy is consisted of passive range of motion exercise and walking exercise. | Procedure or surgery | conventional training group |
Primary outcome
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. 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.
3 secondary outcomes
Maximal voluntary isometric contraction at knee
Time frame: Before intervention / after two weeks intervention
10 meter walking test
Time frame: Before intervention / after two weeks intervention
Hand grip muscle strength
Time frame: Before intervention / after two weeks intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Background: PubMed 20648661Verschueren 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.
- Background: PubMed 20546975Santin-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.
- Background: PubMed 20500555von 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.
- Background: PubMed 19789832Kemmler 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.
- Background: PubMed 19724891Pietrangelo 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.
- Background: PubMed 19422657Machado 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.
- Background: PubMed 18726053Kaeding 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.
- Background: PubMed 17595419Bogaerts 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.
- Background: PubMed 16513017Cardinale 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.
- Background: PubMed 16118292Cardinale 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.
- Background: PubMed 14594190Cardinale 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.
- Background: PubMed 15161453Roelants 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jae-Young Lim, Ph.D. study director
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing whole body vibration plus conventional therapy and conventional therapy in people with Sarcopenia, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jae-Young Lim, Ph.D. (+821053900373, drlim1@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg balance scale (time frame: Before intervention / after two weeks intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03695354, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2021.