Vibration; ExposureNCT05757661
Focal Vibration on the Performance of Amateur Athletes
A study testing Focal Vibration in people with Vibration; Exposure and Sports Physical Therapy, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial summary
Focal vibration is an adjustable instrument, which has the ability to apply vibration to a specific point at different hertz, powers and rhythms. The use of general or focused vibration is not new in the rehabilitation or sports field. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Vibration; Exposure, Sports Physical Therapy
- What is being tested?
- Focal Vibration
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2023to 1 Apr 2023
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Athletes between 18 and 30 years of age (athletics and field sports such as soccer, basketball, rugby... that may involve sprinting) federated and competing in university or national amateur leagues that perform sprinting and jumping in their sports practice.
- Active participation in regional, national or international competitions.
- Study participants must have signed the informed consent form in order to evaluate their inclusion in the study.
Who cannot join
- Volunteers who have suffered a sports injury during the last two months or are unable to perform physical activity.
- Not understanding the information provided by the therapist.
- Participate in other research studies.
- Being under a pharmacological medical treatment that may interfere with the measures, such as treatment with anticonvulsants, antidepressants, etc.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Universitat Internacional de Catalunya
Sant Cugat del Vallès, Barcelona, 08195
Albert Pérez-Bellmunt, PhD, 636817297, aperez@uic.es
About this study
Official title: Effectiveness of Focal Vibration on the Performance of Amateur Athletes
Focal vibration is an adjustable instrument, which has the ability to apply vibration to a specific point at different hertz, powers and rhythms. The use of general or focused vibration is not new in the rehabilitation or sports field. Vibration is intended to stimulate neuromuscular uses to produce involuntary and additional contractions of muscle tissue, indirectly causing an increase in strength or muscle mass , improved fall prevention, mobility and bone consolidation. This type of device has been used both in athletes and in patients with chronic diseases or in intensive care units. There are studies that use vibration in critically ill patients because it is a safe and feasible intervention for dependent patients. One of the advantages of focal vibration is that it can be used in both unloading and loading, which allows a wide range of adaptation to each patient, even simultaneously during a training activity.
The aim of the present study is to evaluate the effectiveness of a focal vibration treatment on strength, jumping and running speed in national federated athletes who perform sprinting and jumping in their sports practice.
Read more
A sample will be recruited during the months of April to September, estimating a sample of 70 total subjects (35 subjects in the vibration group and 35 subjects in the vibration placebo group).
Patients will receive a single treatment and assessments will be performed on the same day.
The focal vibration group will receive a 30-minute quadriceps intervention. 3 channels will be used on the muscle bellies of the rectus anterior, vastus internus and vastus externus. The vibration program configuration will be in an automatic mode of 10 seconds of vibration 3 seconds of rest to avoid mechanoreceptor coupling. The frequency used will be between 60 Hz to 150 Hz with a power of 80%. The placebo group will perform the same treatment as the intervention group but without the focal vibration head contacting the skin (placebo). A sufficient space will be left between the head and the headgear so that the vibration does not touch the skin as shown in previous studies.
A V-Plus machine (Wintecare S.A.) will be used for the vibration treatment. For the assessment measurements, a surface electromyograph, a force measurement dynamometer, the MyJump2 application for jump assessment and two photoelectric cells for sprint measurement will be used.
Read the detailed description
Focal vibration is an adjustable instrument, which has the ability to apply vibration to a specific point at different hertz, powers and rhythms. The use of general or focused vibration is not new in the rehabilitation or sports field. Vibration is intended to stimulate neuromuscular uses to produce involuntary and additional contractions of muscle tissue, indirectly causing an increase in strength or muscle mass , improved fall prevention, mobility and bone consolidation. This type of device has been used both in athletes and in patients with chronic diseases or in intensive care units. There are studies that use vibration in critically ill patients because it is a safe and feasible intervention for dependent patients. One of the advantages of focal vibration is that it can be used in both unloading and loading, which allows a wide range of adaptation to each patient, even simultaneously during a training activity.
As mentioned above, focal vibration has had good results in increasing muscle mass; however, there is no study that has assessed whether focal vibration generates immediate improvements in the performance of functional tests such as jumping, maximum strength or running speed.
Different studies have observed improved activation of muscle fibers after applying global and/or focal vibration; however, it is not known whether activation is maintained in more functional gestures that require maximum effort (such as jumping or sprinting) in trained individuals.
The aim of the present study is to evaluate the effectiveness of a focal vibration treatment on strength, jumping and running speed in national federated athletes who perform sprinting and jumping in their sports practice.
A sample will be recruited during the months of April to September, estimating a sample of 70 total subjects (35 subjects in the vibration group and 35 subjects in the vibration placebo group).
Patients will receive a single treatment and assessments will be performed on the same day.
The focal vibration group will receive a 30-minute quadriceps intervention. 3 channels will be used on the muscle bellies of the rectus anterior, vastus internus and vastus externus. The vibration program configuration will be in an automatic mode of 10 seconds of vibration 3 seconds of rest to avoid mechanoreceptor coupling. The frequency used will be between 60 Hz to 150 Hz with a power of 80%. The placebo group will perform the same treatment as the intervention group but without the focal vibration head contacting the skin (placebo). A sufficient space will be left between the head and the headgear so that the vibration does not touch the skin as shown in previous studies.
A V-Plus machine (Wintecare S.A.) will be used for the vibration treatment. For the assessment measurements, a surface electromyograph, a force measurement dynamometer, the MyJump2 application for jump assessment and two photoelectric cells for sprint measurement will be used.
- Conditions
- Vibration; Exposure, Sports Physical Therapy
- Being tested
- Focal Vibration, Sham Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focal VibrationOther
A single 30-minute focal vibration procedure will be performed on both quadriceps with the V-Plus Wintecare® machine.
Three channels will be used on the muscle bellies of the rectus anterior, vastus internus and vastus externus. The positioning of the vibration heads will be done with straps designed by the manufacturer to keep the vibration focus stable on the muscle belly.
The configuration of the vibration program will be in an automatic mode of 10 seconds of vibration and 3 seconds of rest to avoid the coupling of the mechanoreceptors. The frequency used will be between 60 Hz to 150 Hz with a power of 80%.
Sham GroupOther
The same procedure of the intervention group will be performed but without the focal vibration head contacting the skin (sham). A sufficient space will be left between the head and the headgear so that the vibration does not touch the skin.
| Study group | Role | What they receive |
|---|---|---|
| Focal Vibration Group | Experimental | Not described Receives: Other: Focal Vibration |
| Sham Group | Sham comparator | Not described Receives: Other: Sham Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 30 meters sprint (seconds)
Photoelectric cells will be used to measure the time required to complete a 30-meter sprint.
Measured: Baseline(immediately before intervention) and post intervention (immediately after intervention)
Changes in electromyographic activity during sprint (μ/v)
The mean electromyographic activity of the quadriceps musculature during sprint will be measured with The mDurance® system device (mDurance Solutions SL, Granada, Spain).
Measured: Baseline(immediately before intervention) and post intervention (immediately after intervention)
Secondary outcomes (4)
Countermovement jump (cm)
A bipodal jump will be performed and measured with the validated application "MyJump 2".
Measured: Baseline(immediately before intervention) and post intervention (immediately after intervention)
Changes in electromyographic activity during countermovement jump (μ/v)
The mean electromyographic activity of the quadriceps musculature during the jump will be measured with The mDurance® system device (mDurance Solutions SL, Granada, Spain).
Measured: Baseline(immediately before intervention) and post intervention (immediately after intervention)
Changes in isometric leg extension (Newtons)
A precision dynamometer (Microfeet II) will be used and the maximum force during an isometric contraction of this musculature during 5 seconds of the quadriceps will be analyzed.
Measured: Baseline(immediately before intervention) and post intervention (immediately after intervention)
Changes in electromyographic activity during isometric leg extension (μ/v)
The mean electromyographic activity of the quadriceps musculature during the isometric leg extension will be measured with The mDurance® system device (mDurance Solutions SL, Granada, Spain).
Measured: Baseline(immediately before intervention) and post intervention (immediately after intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start1 Mar 2023 (estimated)
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacobo Rodríguez Sanz, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05757661
- Sponsor's protocol ID
- FIS-2022-05
- Status last verified
- Feb 2023
- First submitted
- 23 Feb 2023
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Canet-Vintro M, Rodriguez-Sanz J, Lopez-de-Celis C, Campana-Arnal E, Hidalgo-Garcia C, Perez-Bellmunt A. Effects of focal vibration on changes in sports performance in amateur athletes: A randomized clinical trial. J Orthop Res. 2024 Sep;42(9):2106-2115. doi: 10.1002/jor.25857. Epub 2024 Apr 10.
PubMed 38598304
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Focal Vibration on the Performance of Amateur Athletes
- ClinicalTrials.gov ID
- NCT05757661
- Acronym / sponsor ID
- FIS-2022-05
- Conditions
- Vibration; Exposure, Sports Physical Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 7 Mar 2023 (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.
Focal vibration is an adjustable instrument, which has the ability to apply vibration to a specific point at different hertz, powers and rhythms. The use of general or focused vibration is not new in the rehabilitation or sports field. Vibration is intended to stimulate neuromuscular uses to produce involuntary and additional contractions of muscle tissue, indirectly causing an increase in strength or muscle mass , improved fall prevention, mobility and bone consolidation. This type of device has been used both in athletes and in patients with chronic diseases or in intensive care units. There are studies that use vibration in critically ill patients because it is a safe and feasible intervention for dependent patients. One of the advantages of focal vibration is that it can be used in both unloading and loading, which allows a wide range of adaptation to each patient, even simultaneously during a training activity.
The aim of the present study is to evaluate the effectiveness of a focal vibration treatment on strength, jumping and running speed in national federated athletes who perform sprinting and jumping in their sports practice.
A sample will be recruited during the months of April to September, estimating a sample of 70 total subjects (35 subjects in the vibration group and 35 subjects in the vibration placebo group).
Patients will receive a single treatment and assessments will be performed on the same day.
The focal vibration group will receive a 30-minute quadriceps intervention. 3 channels will be used on the muscle bellies of the rectus anterior, vastus internus and vastus externus. The vibration program configuration will be in an automatic mode of 10 seconds of vibration 3 seconds of rest to avoid mechanoreceptor coupling. The frequency used will be between 60 Hz to 150 Hz with a power of 80%. The placebo group will perform the same treatment as the intervention group but without the focal vibration head contacting the skin (placebo). A sufficient space will be left between the head and the headgear so that the vibration does not touch the skin as shown in previous studies.
A V-Plus machine (Wintecare S.A.) will be used for the vibration treatment. For the assessment measurements, a surface electromyograph, a force measurement dynamometer, the MyJump2 application for jump assessment and two photoelectric cells for sprint measurement will be used.
Detailed description
Focal vibration is an adjustable instrument, which has the ability to apply vibration to a specific point at different hertz, powers and rhythms. The use of general or focused vibration is not new in the rehabilitation or sports field. Vibration is intended to stimulate neuromuscular uses to produce involuntary and additional contractions of muscle tissue, indirectly causing an increase in strength or muscle mass , improved fall prevention, mobility and bone consolidation. This type of device has been used both in athletes and in patients with chronic diseases or in intensive care units. There are studies that use vibration in critically ill patients because it is a safe and feasible intervention for dependent patients. One of the advantages of focal vibration is that it can be used in both unloading and loading, which allows a wide range of adaptation to each patient, even simultaneously during a training activity.
As mentioned above, focal vibration has had good results in increasing muscle mass; however, there is no study that has assessed whether focal vibration generates immediate improvements in the performance of functional tests such as jumping, maximum strength or running speed.
Different studies have observed improved activation of muscle fibers after applying global and/or focal vibration; however, it is not known whether activation is maintained in more functional gestures that require maximum effort (such as jumping or sprinting) in trained individuals.
The aim of the present study is to evaluate the effectiveness of a focal vibration treatment on strength, jumping and running speed in national federated athletes who perform sprinting and jumping in their sports practice.
A sample will be recruited during the months of April to September, estimating a sample of 70 total subjects (35 subjects in the vibration group and 35 subjects in the vibration placebo group).
Patients will receive a single treatment and assessments will be performed on the same day.
The focal vibration group will receive a 30-minute quadriceps intervention. 3 channels will be used on the muscle bellies of the rectus anterior, vastus internus and vastus externus. The vibration program configuration will be in an automatic mode of 10 seconds of vibration 3 seconds of rest to avoid mechanoreceptor coupling. The frequency used will be between 60 Hz to 150 Hz with a power of 80%. The placebo group will perform the same treatment as the intervention group but without the focal vibration head contacting the skin (placebo). A sufficient space will be left between the head and the headgear so that the vibration does not touch the skin as shown in previous studies.
A V-Plus machine (Wintecare S.A.) will be used for the vibration treatment. For the assessment measurements, a surface electromyograph, a force measurement dynamometer, the MyJump2 application for jump assessment and two photoelectric cells for sprint measurement will be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Focal Vibration Group | Experimental | Other: Focal Vibration |
| Sham Group | Sham comparator | Other: Sham Group |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Athletes between 18 and 30 years of age (athletics and field sports such as soccer, basketball, rugby... that may involve sprinting) federated and competing in university or national amateur leagues that perform sprinting and jumping in their sports practice.
- Active participation in regional, national or international competitions.
- Study participants must have signed the informed consent form in order to evaluate their inclusion in the study.
Key exclusion criteria (4 listed)
- Volunteers who have suffered a sports injury during the last two months or are unable to perform physical activity.
- Not understanding the information provided by the therapist.
- Participate in other research studies.
- Being under a pharmacological medical treatment that may interfere with the measures, such as treatment with anticonvulsants, antidepressants, etc.
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 |
|---|---|---|
| Focal VibrationA single 30-minute focal vibration procedure will be performed on both quadriceps with the V-Plus Wintecare® machine. Three channels will be used on the muscle bellies of the rectus anterior, vastus internus and vastus externus. The positioning of the vibration heads will be done with straps designed by the manufacturer to keep the vibration focus stable on the muscle belly. The configuration of the vibration program will be in an automatic mode of 10 seconds of vibration and 3 seconds of rest to avoid the coupling of the mechanoreceptors. The frequency used will be between 60 Hz to 150 Hz with a power of 80%. | Other | Focal Vibration Group |
| Sham GroupThe same procedure of the intervention group will be performed but without the focal vibration head contacting the skin (sham). A sufficient space will be left between the head and the headgear so that the vibration does not touch the skin. | Other | Sham Group |
Primary outcome
Change in 30 meters sprint (seconds)
Time frame: Baseline(immediately before intervention) and post intervention (immediately after intervention)
Photoelectric cells will be used to measure the time required to complete a 30-meter sprint.
Changes in electromyographic activity during sprint (μ/v)
Time frame: Baseline(immediately before intervention) and post intervention (immediately after intervention)
The mean electromyographic activity of the quadriceps musculature during sprint will be measured with The mDurance® system device (mDurance Solutions SL, Granada, Spain).
4 secondary outcomes
Countermovement jump (cm)
Time frame: Baseline(immediately before intervention) and post intervention (immediately after intervention)
Changes in electromyographic activity during countermovement jump (μ/v)
Time frame: Baseline(immediately before intervention) and post intervention (immediately after intervention)
Changes in isometric leg extension (Newtons)
Time frame: Baseline(immediately before intervention) and post intervention (immediately after intervention)
Changes in electromyographic activity during isometric leg extension (μ/v)
Time frame: Baseline(immediately before intervention) and post intervention (immediately after intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Derived from this study: PubMed 38598304Canet-Vintro M, Rodriguez-Sanz J, Lopez-de-Celis C, Campana-Arnal E, Hidalgo-Garcia C, Perez-Bellmunt A. Effects of focal vibration on changes in sports performance in amateur athletes: A randomized clinical trial. J Orthop Res. 2024 Sep;42(9):2106-2115. doi: 10.1002/jor.25857. Epub 2024 Apr 10.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focal Vibration in people with Vibration; Exposure and Sports Physical Therapy, run by Universitat Internacional de Catalunya at 1 site in Spain.
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 3 inclusion and 4 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 7 Mar 2023. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 30 meters sprint (seconds) (time frame: Baseline(immediately before intervention) and post intervention (immediately after intervention)). The study lists 2 primary outcomes in all. 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 NCT05757661, which also lists 1 linked publication.
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 Mar 2023.