Neuromuscular Performance and BalanceNCT02416362
Immediate Effects of Whole Body Vibration on Neuromuscular Performance of Quadriceps Femoris and Balance
A study testing Vibration at 30 Hz and Vibration at 50 Hz in people with Neuromuscular Performance and Balance, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
Trial summary
The purpose of this study is to analyze the immediate effects of two exercise protocols on the vibration platform, on the strength of the thigh muscles, joint position sense of the knee and balance in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 29 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Neuromuscular Performance and Balance
- What is being tested?
- Vibration at 30 Hz and Vibration at 50 Hz
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2014to Dec 2014
- 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 29 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female sex
- Healthy
- Engaging in physical activity involving lower limbs at least 3 times per week
- Exhibiting ankle, hip and knee joint integrity of the non-dominant limb
- No history of muscle or joint injuries in the assessed limb in the last 6 months, or neurological, visual and/or non-corrected auditory impairments
Who cannot join
- Auto-desistance
- Referring pain or discomfort during the procedures for collection
- Not perform assessment procedures correctly in order to make it impossible to capture the data.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Rio Grande do Norte (UFRN)
Natal, Rio Grande do Norte, 59140-840
About this study
Official title: Immediate Effects of Whole Body Vibration on Neuromuscular Performance of Quadriceps Femoris and Balance of Healthy Women: a Randomized Controlled Trial
The purpose of this study is to analyze the immediate effects of two exercise protocols on the vibration platform, on the strength of the thigh muscles, joint position sense of the knee and balance in healthy subjects.
Read the detailed description
Design and research site: This is a randomized and blinded clinical trial held at the Laboratory of Neuromuscular Performance of the Department of Physical Therapy, Federal University of Rio Grande do Norte (UFRN). Characterization of the sample: The sample consisted of 60 women randomly divided into 3 distinct groups. Ethical aspects: For its implementation, this project was submitted to the Research Ethics Committee (REC) of the Federal University of Rio Grande do Norte. Was respected and ensured the autonomy and anonymity of participants, as well as your privacy as confidential data, as governed Resolution 196/96 of the National Health Council and the Helsinki declaration for human research. Instruments: Stationary bicycle (Ergo-Fit, ErgoCycle 167, Pirmasens, Germany); computerized baropodometry platform Eclipse 3000 model (Guy-Capron® SA, France); vibrating platform model Power Plate® pro5 ™; signal conditioning module (Telemyo direct transmission system) 8-channel (Noraxon, USA); self-adhesive electrode active surface (Noraxon, USA); isokinetic dynamometer (Biodex Multi-Joint System 4, Biomedical Biodex System Inc.®, New York, USA). Procedures: There was a previous pilot study for adequacy of any research procedures and the training of evaluators. The volunteers were informed about the procedures to be performed in the research, signed the informed consent form, fill in an evaluation form with anthropometric data and personal examination of members. Evaluations were performed before and after the intervention protocol. Initially, all the volunteers executed a warming exercise on a stationary bike for 5 minutes. Postural balance: the volunteers were placed standing on the baropodometry platform, supported in the non-dominant member and with the knee kept at 20 ° of flexion. The dominant member remained with the knee in 90 ° of flexion. The evaluation was repeated 3 times, being considered for analysis the average of the two best measures. The evaluation time was 20 seconds on an acquisition frequency of 20 Hz with a period of 1 minute break between tests. Previously the participant was allowed to become familiar with the equipment. Joint position sense: the volunteer was positioned sitting on the dynamometer, stabilized by braces and with the device axis aligned with the knee evaluated. The apparatus of the lever arm was attached to the distal leg. Then, the volunteer was instructed to perform a knee extension member starting with 90 ° of flexion. When the 45 target angle wass reached, the dynamometer arm remained in this position, keeping it for 5 seconds, so that the voluntary noticed which the angle to be achieved. Finally, prompted an active extension from 90 ° knee flexion (1 / s) to the target angle, the second trial of the subject. At that moment, the volunteer should trigger a device to record the angle reached. Torque rating: keeping the same previous position, the normalization of the electromyographic signal was held, where the subject performed two maximal voluntary isometric contractions of knee extension at an angle of 60 ° for 5s, with one-minute interval between each repetition. Then the concentric evaluation was conducted, with 5 maximal contractions for knee flexion and extension at 60 ° / s, starting from 90 ° flexion up to full extension. Electromyographic activity: emg was collected concurrently with exercise protocols on the platform, as well as during the torque rating. The volunteers were submitted for shaving and cleaning the skin with 70% alcohol before attaching the electrodes.
- Conditions
- Neuromuscular Performance and Balance
- Being tested
- Vibration at 30 Hz, Vibration at 50 Hz
- Keywords
- Postural Balance, Electromyography, Torque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibration at 30 HzOther
During the exercise protocol, the vibration platform will be turned on at a vibration frequency of 30 Hz.
Vibration at 50 HzOther
During the exercise protocol, the vibration platform will be turned on at a vibration frequency of 50 Hz.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The control group (No vibration) will hold an exercise protocol on the vibration platform, which is to stay on one foot on the non-dominant leg, with the knee held in 40 ° of flexion, hands together to the body and the trunk in the erect position. Altogether, the participant will perform 11 sets of 30 seconds with a rest interval of 30 seconds between sets. The knee angle will be monitored throughout the protocol by the second reviewer with a goniometer so that there is no change in it. The vibrating platform will remain off throughout intervention. |
| GE1 | Experimental | The GE1 (Vibration at 30 Hz) group will hold an exercise protocol on the vibration platform, which is to stay on one foot on the non-dominant leg, with the knee held in 40 ° of flexion, hands together to the body and the trunk in the erect position. Altogether, the participant will perform 11 sets of 30 seconds with a rest interval of 30 seconds between sets. The knee angle will be monitored throughout the protocol by the second reviewer with a goniometer so that there is no change in it. During the sets the vibrating platform will be turned on at a vibration frequency of 30 Hz. Receives: Other: Vibration at 30 Hz |
| GE2 | Experimental | The GE1 (Vibration at 50 Hz) group will hold an exercise protocol on the vibration platform, which is to stay on one foot on the non-dominant leg, with the knee held in 40 ° of flexion, hands together to the body and the trunk in the erect position. Altogether, the participant will perform 11 sets of 30 seconds with a rest interval of 30 seconds between sets. The knee angle will be monitored throughout the protocol by the second reviewer with a goniometer so that there is no change in it. During the sets the vibrating platform will be turned on at a vibration frequency of 50 Hz. Receives: Other: Vibration at 50 Hz |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Performance measured through isokinetic dynamometry
The muscle performance will be measured through isokinetic dynamometry and the variables analyzed will be peak torque normalized for body weight, mean power, total work and time to peak torque.
Measured: Baseline, immediately after the intervention protocol
Secondary outcomes (3)
Proprioception measured through joint position sense in the isokinetic dynamometer
The proprioception will be measured through joint position sense
Measured: Baseline, immediately after the intervention protocol
Muscle activation measured through surface electromyography
Measured by surface electromyography
Measured: Baseline, immediately after the intervention protocol
Balance measured through baropodometry
Measured by baropodometry
Measured: Baseline, immediately after the intervention protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study startAug 2014
- Primary completionNov 2014
- Study completionDec 2014
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 Neuromuscular Performance and BalanceStudies 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamilson Simões Brasileiro, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02416362
- Sponsor's protocol ID
- DTB2014
- Status last verified
- Apr 2015
- First submitted
- 17 Mar 2015
- Last updated
- 15 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Borges DT, Macedo LB, Lins CA, Brasileiro JS. Immediate effects of whole-body vibration on neuromuscular performance of quadriceps and oscillation of the center of pressure: A randomized controlled trial. Man Ther. 2016 Sep;25:62-8. doi: 10.1016/j.math.2016.06.005. Epub 2016 Jun 16.
PubMed 27422599
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of Whole Body Vibration on Neuromuscular Performance of Quadriceps Femoris and Balance of Healthy Women: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02416362
- Acronym / sponsor ID
- DTB2014
- Conditions
- Neuromuscular Performance and Balance
- Keywords
- Postural Balance, Electromyography, Torque
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 15 Apr 2015 (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 purpose of this study is to analyze the immediate effects of two exercise protocols on the vibration platform, on the strength of the thigh muscles, joint position sense of the knee and balance in healthy subjects.
Detailed description
Design and research site: This is a randomized and blinded clinical trial held at the Laboratory of Neuromuscular Performance of the Department of Physical Therapy, Federal University of Rio Grande do Norte (UFRN). Characterization of the sample: The sample consisted of 60 women randomly divided into 3 distinct groups. Ethical aspects: For its implementation, this project was submitted to the Research Ethics Committee (REC) of the Federal University of Rio Grande do Norte. Was respected and ensured the autonomy and anonymity of participants, as well as your privacy as confidential data, as governed Resolution 196/96 of the National Health Council and the Helsinki declaration for human research. Instruments: Stationary bicycle (Ergo-Fit, ErgoCycle 167, Pirmasens, Germany); computerized baropodometry platform Eclipse 3000 model (Guy-Capron® SA, France); vibrating platform model Power Plate® pro5 ™; signal conditioning module (Telemyo direct transmission system) 8-channel (Noraxon, USA); self-adhesive electrode active surface (Noraxon, USA); isokinetic dynamometer (Biodex Multi-Joint System 4, Biomedical Biodex System Inc.®, New York, USA). Procedures: There was a previous pilot study for adequacy of any research procedures and the training of evaluators. The volunteers were informed about the procedures to be performed in the research, signed the informed consent form, fill in an evaluation form with anthropometric data and personal examination of members. Evaluations were performed before and after the intervention protocol. Initially, all the volunteers executed a warming exercise on a stationary bike for 5 minutes. Postural balance: the volunteers were placed standing on the baropodometry platform, supported in the non-dominant member and with the knee kept at 20 ° of flexion. The dominant member remained with the knee in 90 ° of flexion. The evaluation was repeated 3 times, being considered for analysis the average of the two best measures. The evaluation time was 20 seconds on an acquisition frequency of 20 Hz with a period of 1 minute break between tests. Previously the participant was allowed to become familiar with the equipment. Joint position sense: the volunteer was positioned sitting on the dynamometer, stabilized by braces and with the device axis aligned with the knee evaluated. The apparatus of the lever arm was attached to the distal leg. Then, the volunteer was instructed to perform a knee extension member starting with 90 ° of flexion. When the 45 target angle wass reached, the dynamometer arm remained in this position, keeping it for 5 seconds, so that the voluntary noticed which the angle to be achieved. Finally, prompted an active extension from 90 ° knee flexion (1 / s) to the target angle, the second trial of the subject. At that moment, the volunteer should trigger a device to record the angle reached. Torque rating: keeping the same previous position, the normalization of the electromyographic signal was held, where the subject performed two maximal voluntary isometric contractions of knee extension at an angle of 60 ° for 5s, with one-minute interval between each repetition. Then the concentric evaluation was conducted, with 5 maximal contractions for knee flexion and extension at 60 ° / s, starting from 90 ° flexion up to full extension. Electromyographic activity: emg was collected concurrently with exercise protocols on the platform, as well as during the torque rating. The volunteers were submitted for shaving and cleaning the skin with 70% alcohol before attaching the electrodes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The control group (No vibration) will hold an exercise protocol on the vibration platform, which is to stay on one foot on the non-dominant leg, with the knee held in 40 ° of flexion, hands together to the body and the trunk in the erect position. Altogether, the participant will perform 11 sets of 30 seconds with a rest interval of 30 seconds between sets. The knee angle will be monitored throughout the protocol by the second reviewer with a goniometer so that there is no change in it. The vibrating platform will remain off throughout intervention. |
| GE1 | Experimental | Other: Vibration at 30 HzThe GE1 (Vibration at 30 Hz) group will hold an exercise protocol on the vibration platform, which is to stay on one foot on the non-dominant leg, with the knee held in 40 ° of flexion, hands together to the body and the trunk in the erect position. Altogether, the participant will perform 11 sets of 30 seconds with a rest interval of 30 seconds between sets. The knee angle will be monitored throughout the protocol by the second reviewer with a goniometer so that there is no change in it. During the sets the vibrating platform will be turned on at a vibration frequency of 30 Hz. |
| GE2 | Experimental | Other: Vibration at 50 HzThe GE1 (Vibration at 50 Hz) group will hold an exercise protocol on the vibration platform, which is to stay on one foot on the non-dominant leg, with the knee held in 40 ° of flexion, hands together to the body and the trunk in the erect position. Altogether, the participant will perform 11 sets of 30 seconds with a rest interval of 30 seconds between sets. The knee angle will be monitored throughout the protocol by the second reviewer with a goniometer so that there is no change in it. During the sets the vibrating platform will be turned on at a vibration frequency of 50 Hz. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female sex
- Healthy
- Engaging in physical activity involving lower limbs at least 3 times per week
- Exhibiting ankle, hip and knee joint integrity of the non-dominant limb
- No history of muscle or joint injuries in the assessed limb in the last 6 months, or neurological, visual and/or non-corrected auditory impairments
Key exclusion criteria (3 listed)
- Auto-desistance
- Referring pain or discomfort during the procedures for collection
- Not perform assessment procedures correctly in order to make it impossible to capture the data.
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 |
|---|---|---|
| Vibration at 30 HzDuring the exercise protocol, the vibration platform will be turned on at a vibration frequency of 30 Hz. | Other | GE1 |
| Vibration at 50 HzDuring the exercise protocol, the vibration platform will be turned on at a vibration frequency of 50 Hz. | Other | GE2 |
Primary outcome
Muscle Performance measured through isokinetic dynamometry
Time frame: Baseline, immediately after the intervention protocol
The muscle performance will be measured through isokinetic dynamometry and the variables analyzed will be peak torque normalized for body weight, mean power, total work and time to peak torque.
3 secondary outcomes
Proprioception measured through joint position sense in the isokinetic dynamometer
Time frame: Baseline, immediately after the intervention protocol
Muscle activation measured through surface electromyography
Time frame: Baseline, immediately after the intervention protocol
Balance measured through baropodometry
Time frame: Baseline, immediately after the intervention protocol
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 15 Apr 2015.
- Derived from this study: PubMed 27422599Borges DT, Macedo LB, Lins CA, Brasileiro JS. Immediate effects of whole-body vibration on neuromuscular performance of quadriceps and oscillation of the center of pressure: A randomized controlled trial. Man Ther. 2016 Sep;25:62-8. doi: 10.1016/j.math.2016.06.005. Epub 2016 Jun 16.
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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 Vibration at 30 Hz and Vibration at 50 Hz in people with Neuromuscular Performance and Balance, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
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 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 15 Apr 2015. 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 Brazil. 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 Performance measured through isokinetic dynamometry (time frame: Baseline, immediately after the intervention protocol). 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 NCT02416362, 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 15 Apr 2015; AzTrials last refreshed its copy on 7 Nov 2026.