Vibration; ExposureMusMechProNCT04738916
Vibration Training in Healthy Individuals
A study testing Whole-body vibration training in people with Vibration; Exposure and Muscle Strength, run by Okan University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study was to examine the effect of six-week constant, low frequency and low amplitude Whole Body Vibration training on the strength and mechanical properties of the lower limb knee extensors and ankle joint dorsi flexor muscles. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Vibration; Exposure, Muscle Strength, Lower Limb
- What is being tested?
- Whole-body vibration training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Jan 2020to 30 Apr 2020
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteering
- Weight less than 120 kg
Who cannot join
- The presence of a history of trauma in the lower extremity in the last six months
- Limitation of movement in the lower extremity
- A history of cardiovascular, neurological, orthopedic disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Okan University Sports Laboratory
Istanbul, 34959
About this study
Official title: The Impact of Low-intensity Whole-body Vibration Training on Extensor Muscles Strength, and Mechanical Properties of Lower Limb
The aim of the study was to examine the effect of six-week constant, low frequency and low amplitude Whole Body Vibration training on the strength and mechanical properties of the lower limb knee extensors and ankle joint dorsi flexor muscles.
Read the detailed description
The aim of the study was to examine the effect of six-week constant, low frequency and low amplitude Whole Body Vibration training on the strength and mechanical properties of the lower limb knee extensors and ankle joint dorsi flexor muscles.
- Conditions
- Vibration; Exposure, Muscle Strength, Lower Limb
- Being tested
- Whole-body vibration training
- Keywords
- muscle mechanical properties
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-body vibration trainingDevice
Whole body vibration (WBV) is a form of treatment that has been shown to have an important role in increasing neuromuscular performance, improving muscular strength, balance. The technique involves standing and holding positions, or performing prescribed exercises, on a platform that is vibrating at a programmed frequency, amplitude, and magnitude of oscillationWhole-body vibration (WBV) is a therapeutic method that exposes the entire body to mechanical oscillations while the patient stands or sits on a vibrating platform.
| Study group | Role | What they receive |
|---|---|---|
| Vibration Group | Experimental | The vibration group was included in the low frequency (25 Hz), low amplitude (2mm), fixed six-week training on two non-consecutive days of the week. Receives: Device: Whole-body vibration training |
| Control Group | No intervention | No training was given to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle mechanical properties
MyotonPRO evaluation: Non-invasive assessment of state of tension, biomechanical and viscoelastic properties of lower limb extensors.
Measured: at 6-week
Secondary outcomes (1)
Muscle Strength
Lafayette: Hand-held dynamometer evaluation
Measured: at 6-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start11 Jan 2020
- Primary completion30 Mar 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vibration; ExposureStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Collaborators
- Bitlis Eren University
- Responsible party
- Principal investigator, Filiz Basol, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04738916
- Sponsor's protocol ID
- BEU
- Acronym
- MusMechPro
- Status last verified
- Mar 2021
- First submitted
- 27 Jan 2021
- Last updated
- 4 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Low-intensity Whole-body Vibration Training on Extensor Muscles Strength, and Mechanical Properties of Lower Limb
- ClinicalTrials.gov ID
- NCT04738916
- Acronym / sponsor ID
- MusMechPro / BEU
- Conditions
- Vibration; Exposure, Muscle Strength, Lower Limb
- Keywords
- muscle mechanical properties
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Collaborators
- Bitlis Eren University
- Study start
- 11 Jan 2020 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 4 Feb 2021 (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.
The aim of the study was to examine the effect of six-week constant, low frequency and low amplitude Whole Body Vibration training on the strength and mechanical properties of the lower limb knee extensors and ankle joint dorsi flexor muscles.
Detailed description
The aim of the study was to examine the effect of six-week constant, low frequency and low amplitude Whole Body Vibration training on the strength and mechanical properties of the lower limb knee extensors and ankle joint dorsi flexor muscles.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vibration Group | Experimental | Device: Whole-body vibration trainingThe vibration group was included in the low frequency (25 Hz), low amplitude (2mm), fixed six-week training on two non-consecutive days of the week. |
| Control Group | No intervention | –No training was given to the control group. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Volunteering
- Weight less than 120 kg
Key exclusion criteria (3 listed)
- The presence of a history of trauma in the lower extremity in the last six months
- Limitation of movement in the lower extremity
- A history of cardiovascular, neurological, orthopedic disease
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 trainingWhole body vibration (WBV) is a form of treatment that has been shown to have an important role in increasing neuromuscular performance, improving muscular strength, balance. The technique involves standing and holding positions, or performing prescribed exercises, on a platform that is vibrating at a programmed frequency, amplitude, and magnitude of oscillationWhole-body vibration (WBV) is a therapeutic method that exposes the entire body to mechanical oscillations while the patient stands or sits on a vibrating platform. | Device | Vibration Group |
Primary outcome
Muscle mechanical properties
Time frame: at 6-week
MyotonPRO evaluation: Non-invasive assessment of state of tension, biomechanical and viscoelastic properties of lower limb extensors.
1 secondary outcome
Muscle Strength
Time frame: at 6-week
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 4 Mar 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 training in people with Vibration; Exposure and Muscle Strength, run by Okan University 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 2 inclusion and 3 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 4 Mar 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 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?
Muscle mechanical properties (time frame: at 6-week). 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 4 Mar 2021.