Muscle PhysiologyCTEWBWNCT03750799
Cross-training Effect of Whole-body Vibration
A study testing Whole body vibration in people with Muscle Physiology, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates whether an increase in the ipsilateral knee flexor muscle strength transfers to the contralateral knee extensors which are not exposed to vibration, when unilateral-isolated whole body vibration (WBV) is applied to the lower extremity. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Physiology
- What is being tested?
- Whole body vibration
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Nov 2018to 1 Feb 2019
- 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 20 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men with ages between 20-50 years
- Being healthy
- Being volunteer
- Right-sided dominant
Who cannot join
- Non-cooperative subject
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Istanbul
About this study
This study evaluates whether an increase in the ipsilateral knee flexor muscle strength transfers to the contralateral knee extensors which are not exposed to vibration, when unilateral-isolated whole body vibration (WBV) is applied to the lower extremity. In the half of volunteers the right leg were exposed vibration, while in the other half the right leg were exposed sham vibration. Muscle strength were measured with the Cybex® (Massachusetts, USA) extremity-testing system.
Read the detailed description
This study was included 40 healthy volunteers. The change in the quadriceps muscle strength after 20 session of WBV exercises was evaluated this study. In the WBV group, 20 sessions of unilateral lower extremity vibration exercises were performed with the Whole Body Vibration (WBV) device. WBV was applied when the subjects are in the semi-squat position. WBV was implemented with Powerplate® Pro5 (PowerPlate® International Ltd, London, United Kingdom). During 20 sessions, the WBV amplitude and vibration time were increased gradually. In the first session, the subjects were do a 30-second, 30-35, 40- and 45-Hz low-amplitude WBV while the knee and hip joint were in 30 degrees of flexion (in the semi-squat position); 10-second rest period between vibration applications were applied. A total duration of WBV was be two minutes. In the 20th session, the subjects were given a 60-second, 30-, 35-, 40- and 45-Hz high-amplitude WBV while the knee and hip joint were in 45 degrees of flexion; 10-second rest period between vibration applications were applied. A total duration of WBV was eight minutes. During WBV, the left lower extremity was in the knee-hip flexion position but was not exposed the vibration.
The same experimental protocol was applied to the isometric exercise (control) group. Unlike the experimental group, sham vibration was applied to the control group. Before and after 20 session-exercise, both knee extensor isokinetic muscle strength was measured.
- Conditions
- Muscle Physiology
- Being tested
- Whole body vibration, Sham vibration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole body vibrationDevice
Whole body vibration was applied on the right lower extremity in the experimental group.
Sham vibrationDevice
Sham vibration was applied on the right lower extremity in the Control sham group
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Whole body vibration was applied on the right lower extremity. Receives: Device: Whole body vibration |
| Sham group | Sham comparator | Unlike the experimental group, sham vibration was applied to the control group. Receives: Device: Sham vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength gain of the untrained contralateral quadriceps muscle
Untrained contralateral quadriceps muscle strength was measured with the Cybex extremity-testing system before and after trial. Unit of this parameter was Nm
Measured: four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start12 Nov 2018
- Primary completion1 Jan 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Muscle PhysiologyStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental group was exposed WBV, Control group was exposed sham WBV
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ilhan KARACAN, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Investigators
- Ilhan Karacan, Assoc Prof, Study chair, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03750799
- Sponsor's protocol ID
- IstPMRTRH-BMR2
- Acronym
- CTEWBW
- Status last verified
- Apr 2019
- First submitted
- 18 Nov 2018
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karacan I, Cidem M, Cidem M, Turker KS. Whole-body vibration induces distinct reflex patterns in human soleus muscle. J Electromyogr Kinesiol. 2017 Jun;34:93-101. doi: 10.1016/j.jelekin.2017.04.007. Epub 2017 Apr 24.
PubMed 28457998Karacan I, Cidem M, Yilmaz G, Sebik O, Cakar HI, Turker KS. Tendon reflex is suppressed during whole-body vibration. J Electromyogr Kinesiol. 2016 Oct;30:191-5. doi: 10.1016/j.jelekin.2016.07.008. Epub 2016 Jul 25.
PubMed 27485766Cakar HI, Cidem M, Sebik O, Yilmaz G, Karamehmetoglu SS, Kara S, Karacan I, Turker KS. Whole-body vibration-induced muscular reflex: Is it a stretch-induced reflex? J Phys Ther Sci. 2015 Jul;27(7):2279-84. doi: 10.1589/jpts.27.2279. Epub 2015 Jul 22.
PubMed 26310784Karamehmetoglu SS, Karacan I, Cidem M, Kucuk SH, Ekmekci H, Bahadir C. Effects of osteocytes on vibration-induced reflex muscle activity in postmenopausal women. Turk J Med Sci. 2014;44(4):630-8.
PubMed 25551934Cidem M, Karacan I, Diracoglu D, Yildiz A, Kucuk SH, Uludag M, Gun K, Ozkaya M, Karamehmetoglu SS. A Randomized Trial on the Effect of Bone Tissue on Vibration-induced Muscle Strength Gain and Vibration-induced Reflex Muscle Activity. Balkan Med J. 2014 Mar;31(1):11-22. doi: 10.5152/balkanmedj.2013.9482. Epub 2014 Mar 1.
PubMed 25207162Cakar HI, Cidem M, Kara S, Karacan I. Vibration paradox and H-reflex suppression: is H-reflex suppression results from distorting effect of vibration? J Musculoskelet Neuronal Interact. 2014 Sep;14(3):318-24.
PubMed 25198227
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-training Effect of Whole-body Vibration
- ClinicalTrials.gov ID
- NCT03750799
- Acronym / sponsor ID
- CTEWBW / IstPMRTRH-BMR2
- Conditions
- Muscle Physiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 12 Nov 2018 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 23 Nov 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.
This study evaluates whether an increase in the ipsilateral knee flexor muscle strength transfers to the contralateral knee extensors which are not exposed to vibration, when unilateral-isolated whole body vibration (WBV) is applied to the lower extremity. In the half of volunteers the right leg were exposed vibration, while in the other half the right leg were exposed sham vibration. Muscle strength were measured with the Cybex® (Massachusetts, USA) extremity-testing system.
Detailed description
This study was included 40 healthy volunteers. The change in the quadriceps muscle strength after 20 session of WBV exercises was evaluated this study. In the WBV group, 20 sessions of unilateral lower extremity vibration exercises were performed with the Whole Body Vibration (WBV) device. WBV was applied when the subjects are in the semi-squat position. WBV was implemented with Powerplate® Pro5 (PowerPlate® International Ltd, London, United Kingdom). During 20 sessions, the WBV amplitude and vibration time were increased gradually. In the first session, the subjects were do a 30-second, 30-35, 40- and 45-Hz low-amplitude WBV while the knee and hip joint were in 30 degrees of flexion (in the semi-squat position); 10-second rest period between vibration applications were applied. A total duration of WBV was be two minutes. In the 20th session, the subjects were given a 60-second, 30-, 35-, 40- and 45-Hz high-amplitude WBV while the knee and hip joint were in 45 degrees of flexion; 10-second rest period between vibration applications were applied. A total duration of WBV was eight minutes. During WBV, the left lower extremity was in the knee-hip flexion position but was not exposed the vibration.
The same experimental protocol was applied to the isometric exercise (control) group. Unlike the experimental group, sham vibration was applied to the control group. Before and after 20 session-exercise, both knee extensor isokinetic muscle strength was measured.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Experimental group was exposed WBV, Control group was exposed sham WBV
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Whole body vibrationWhole body vibration was applied on the right lower extremity. |
| Sham group | Sham comparator | Device: Sham vibrationUnlike the experimental group, sham vibration was applied to the control group. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Men with ages between 20-50 years
- Being healthy
- Being volunteer
- Right-sided dominant
Key exclusion criteria (1 listed)
- Non-cooperative subject
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 vibrationWhole body vibration was applied on the right lower extremity in the experimental group. | Device | Experimental group |
| Sham vibrationSham vibration was applied on the right lower extremity in the Control sham group | Device | Sham group |
Primary outcome
Muscle strength gain of the untrained contralateral quadriceps muscle
Time frame: four months
Untrained contralateral quadriceps muscle strength was measured with the Cybex extremity-testing system before and after trial. Unit of this parameter was Nm
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Background: PubMed 28457998Karacan I, Cidem M, Cidem M, Turker KS. Whole-body vibration induces distinct reflex patterns in human soleus muscle. J Electromyogr Kinesiol. 2017 Jun;34:93-101. doi: 10.1016/j.jelekin.2017.04.007. Epub 2017 Apr 24.
- Background: PubMed 27485766Karacan I, Cidem M, Yilmaz G, Sebik O, Cakar HI, Turker KS. Tendon reflex is suppressed during whole-body vibration. J Electromyogr Kinesiol. 2016 Oct;30:191-5. doi: 10.1016/j.jelekin.2016.07.008. Epub 2016 Jul 25.
- Background: PubMed 26310784Cakar HI, Cidem M, Sebik O, Yilmaz G, Karamehmetoglu SS, Kara S, Karacan I, Turker KS. Whole-body vibration-induced muscular reflex: Is it a stretch-induced reflex? J Phys Ther Sci. 2015 Jul;27(7):2279-84. doi: 10.1589/jpts.27.2279. Epub 2015 Jul 22.
- Background: PubMed 25551934Karamehmetoglu SS, Karacan I, Cidem M, Kucuk SH, Ekmekci H, Bahadir C. Effects of osteocytes on vibration-induced reflex muscle activity in postmenopausal women. Turk J Med Sci. 2014;44(4):630-8.
- Background: PubMed 25207162Cidem M, Karacan I, Diracoglu D, Yildiz A, Kucuk SH, Uludag M, Gun K, Ozkaya M, Karamehmetoglu SS. A Randomized Trial on the Effect of Bone Tissue on Vibration-induced Muscle Strength Gain and Vibration-induced Reflex Muscle Activity. Balkan Med J. 2014 Mar;31(1):11-22. doi: 10.5152/balkanmedj.2013.9482. Epub 2014 Mar 1.
- Background: PubMed 25198227Cakar HI, Cidem M, Kara S, Karacan I. Vibration paradox and H-reflex suppression: is H-reflex suppression results from distorting effect of vibration? J Musculoskelet Neuronal Interact. 2014 Sep;14(3):318-24.
- 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.
Ilhan Karacan, Assoc Prof study chair
Istanbul Physical Medicine Rehabilitation Training and Research 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 in people with Muscle Physiology, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 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: finished, as of the sponsor's last update on 18 Apr 2019. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle strength gain of the untrained contralateral quadriceps muscle (time frame: four months). 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 NCT03750799, which also lists 6 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 18 Apr 2019.