- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02416362
Immediate Effects of Whole Body Vibration on Neuromuscular Performance of Quadriceps Femoris and Balance
April 9, 2015 updated by: Jamilson Simões Brasileiro, Universidade Federal do Rio Grande do Norte
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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RN
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Natal, RN, Brazil, 59140-840
- Federal University of Rio Grande do Norte (UFRN)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 29 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
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.
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|
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Experimental: GE1
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.
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During the exercise protocol, the vibration platform will be turned on at a vibration frequency of 30 Hz.
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Experimental: GE2
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.
|
During the exercise protocol, the vibration platform will be turned on at a vibration frequency of 50 Hz.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Baseline, immediately after the intervention protocol
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proprioception measured through joint position sense in the isokinetic dynamometer
Time Frame: Baseline, immediately after the intervention protocol
|
The proprioception will be measured through joint position sense
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Baseline, immediately after the intervention protocol
|
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Muscle activation measured through surface electromyography
Time Frame: Baseline, immediately after the intervention protocol
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Measured by surface electromyography
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Baseline, immediately after the intervention protocol
|
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Balance measured through baropodometry
Time Frame: Baseline, immediately after the intervention protocol
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Measured by baropodometry
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Baseline, immediately after the intervention protocol
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2014
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
March 17, 2015
First Submitted That Met QC Criteria
April 9, 2015
First Posted (Estimate)
April 15, 2015
Study Record Updates
Last Update Posted (Estimate)
April 15, 2015
Last Update Submitted That Met QC Criteria
April 9, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- DTB2014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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