Bone MassWBV-BMNCT01419782
Effects of Unilateral WBV on Muscleactivity of Contralateral Hip Adductor
A study testing Whole-body vibration in people with Bone Mass and Effects of Vibration, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate effects of femur exposed to unilateral vibration on the rest muscle electrical activity of contralateral hip adductors and contralateral soleus H-reflex in young adult men. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bone Mass, Effects of Vibration
- What is being tested?
- Whole-body vibration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2011to Dec 2012
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 20-40 yrs
- Gender: Male
- Volunteer
- Healthy status: Patients having hypoesthesia in his leg and Healthy subjects
- Dominant hand:Right-handed
Who cannot join
- Bone diseases (osteoporosis, osteomalacia, paget's disease, neoplasm, etc),
- Systemic diseases (cardiovascular, endocrine, infections etc),
- Myopathy-tendinopathy
- Lower limb joint disease
- Vertigo
- Obesity (BMI >30 kg/m2)
Show all 11Show fewer
- Professional sportsman
- Male doing regular sports activities
- Skin disease in lower limb
- Non-cooperative subject
- Hemolysis of blood sample
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bagcilar Training & Research Hospital
Istanbul
About this study
Official title: The Effects Of Femur On The Resting Myoelectrical Activity Of Contralateral Adductor Muscle During Unilateral Lower Extremity Vibration: Bone Myoregulation Reflex
The aim of this study is to investigate effects of femur exposed to unilateral vibration on the rest muscle electrical activity of contralateral hip adductors and contralateral soleus H-reflex in young adult men.
This study hypothesize that femur exposed to unilateral vibration may affect the rest muscle electrical activity of contralateral hip adductors. Vibration can effectively enhance muscle strength and power. Previous studies have shown that vibration increases muscle electromyographic (EMG) activity. It has been showed that bone has an effect on the increase in muscle EMG activity caused by vibration in healthy young adults in a study. In this study, it was reported that vibrations-induced increases in muscle electrical activity of flexor carpi radialis (FCR) was related to ultradistal radius bone mineral content (BMC) and the FCR H-reflex was suppressed or depressed during vibration. This findings were reported to support the assumption that the bone exposed to cyclic mechanical loading may neuronally regulate muscle activity.
Read the detailed description
A total of 20 voluntaries are planned to include in this study.
Vibration will be applied the right lower extremity by whole-body vibration (PowerPlate Pro). Cases will stand on vibration plate. WBV will be applied at a frequency of 40 Hz and amplitude of 2 mm for 60 seconds. WBV will be applied one session only.
The rest muscle electrical activity of ipsilateral and contralateral hip adductor muscles at rest will be measured by PowerLab (data acquisition system, ADInstruments, Australia) device.The rest-EMGrms will be measured at before and during vibration. We also evaluate a change in contralateral soleus H reflex during vibration.
Effects of bone on the rest muscle electrical activity will be assessed by hip bone mineral density, bone mineral content and serum sclerostin level. The right hip bone mineral density (BMD) and BMC will be evaluated by bone densitometer (Norland). Plasma sclerostin level will be measured by using Human Sclerostin ELISA kıt before and after vibration.
- Conditions
- Bone Mass, Effects of Vibration
- Being tested
- Whole-body vibration
- Keywords
- bone, osteocyte, rest muscle electrical activity, whole-body vibration, sclerostin
- Medical subject headings
- Sclerosteosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-body vibrationOther
Also called Cyclic mechanical loading
Frequency: 40 Hz, vibration amplitude: 2 mm, duration: 60 sec
| Study group | Role | What they receive |
|---|---|---|
| Whole-body vibration | Experimental | whole body vibration will be applied the right lower limb. Receives: Other: Whole-body vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vibration-induced contralateral muscle electrical activity
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2011 (estimated)
- Study startMar 2011
- Primary completionNov 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone MassStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bagcilar Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ilhan Karacan, Clinical Associated Professor, Bagcilar Training and Research Hospital
- Investigators
- ILHAN KARACAN, MD, Principal investigator, Bagcilar Training & Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01419782
- Sponsor's protocol ID
- BEAH FTR-5
- Acronym
- WBV-BM
- Status last verified
- May 2013
- First submitted
- 17 Aug 2011
- Last updated
- 7 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects Of Femur On The Resting Myoelectrical Activity Of Contralateral Adductor Muscle During Unilateral Lower Extremity Vibration: Bone Myoregulation Reflex
- ClinicalTrials.gov ID
- NCT01419782
- Acronym / sponsor ID
- WBV-BM / BEAH FTR-5
- Conditions
- Bone Mass, Effects of Vibration
- Keywords
- bone, osteocyte, rest muscle electrical activity, whole-body vibration, sclerostin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Bagcilar Training and Research HospitalOther government
- Study start
- Mar 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 18 Aug 2011 (estimated)
- 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.
The aim of this study is to investigate effects of femur exposed to unilateral vibration on the rest muscle electrical activity of contralateral hip adductors and contralateral soleus H-reflex in young adult men.
This study hypothesize that femur exposed to unilateral vibration may affect the rest muscle electrical activity of contralateral hip adductors. Vibration can effectively enhance muscle strength and power. Previous studies have shown that vibration increases muscle electromyographic (EMG) activity. It has been showed that bone has an effect on the increase in muscle EMG activity caused by vibration in healthy young adults in a study. In this study, it was reported that vibrations-induced increases in muscle electrical activity of flexor carpi radialis (FCR) was related to ultradistal radius bone mineral content (BMC) and the FCR H-reflex was suppressed or depressed during vibration. This findings were reported to support the assumption that the bone exposed to cyclic mechanical loading may neuronally regulate muscle activity.
Detailed description
A total of 20 voluntaries are planned to include in this study.
Vibration will be applied the right lower extremity by whole-body vibration (PowerPlate Pro). Cases will stand on vibration plate. WBV will be applied at a frequency of 40 Hz and amplitude of 2 mm for 60 seconds. WBV will be applied one session only.
The rest muscle electrical activity of ipsilateral and contralateral hip adductor muscles at rest will be measured by PowerLab (data acquisition system, ADInstruments, Australia) device.The rest-EMGrms will be measured at before and during vibration. We also evaluate a change in contralateral soleus H reflex during vibration.
Effects of bone on the rest muscle electrical activity will be assessed by hip bone mineral density, bone mineral content and serum sclerostin level. The right hip bone mineral density (BMD) and BMC will be evaluated by bone densitometer (Norland). Plasma sclerostin level will be measured by using Human Sclerostin ELISA kıt before and after vibration.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Whole-body vibration | Experimental | Other: Whole-body vibrationwhole body vibration will be applied the right lower limb. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age: 20-40 yrs
- Gender: Male
- Volunteer
- Healthy status: Patients having hypoesthesia in his leg and Healthy subjects
- Dominant hand:Right-handed
Key exclusion criteria (11 listed)
- Bone diseases (osteoporosis, osteomalacia, paget's disease, neoplasm, etc),
- Systemic diseases (cardiovascular, endocrine, infections etc),
- Myopathy-tendinopathy
- Lower limb joint disease
- Vertigo
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 vibrationAlso: Cyclic mechanical loadingFrequency: 40 Hz, vibration amplitude: 2 mm, duration: 60 sec | Other | Whole-body vibration |
Primary outcome
Vibration-induced contralateral muscle electrical activity
Time frame: 3 month
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 7 May 2013.
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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, MD principal investigator
Bagcilar Training & 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 Bone Mass and Effects of Vibration, run by Bagcilar 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 5 inclusion and 11 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 7 May 2013. 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. 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?
Vibration-induced contralateral muscle electrical activity (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2013.