- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04809415
Influence of Power and Wavelength on Photobiomodulation Therapy for Muscle Performance in Healthy Subjects
Study Overview
Status
Intervention / Treatment
Detailed Description
It is a blinded randomized clinical trial. The volunteers will undergo pre-evaluation, 5 weeks of training associated with the LED application, being distributed in two applications per week, and a re-evaluation 24 hours after the last application, totaling a total of approximately 7 weeks. Thus, on the first day (Pre-test) volunteers will be submitted to anthropometric evaluation and evaluation by bioimpedance for analysis of detailed body composition. Then, the maximum voluntary contraction test (CVM) will be performed on the isokinetic dynamometer, together with the electromyographic evaluation. Before and after the evaluation with the isokinetic dynamometer, thermography will be collected. Still, will be evaluated the vertical jump test after 15 minutes of passive rest.
After the initial evaluations, the researcher will go apply the respective interventions, which consist of applying LEDs all over the quadriceps and hamstring bilaterally, while the sham group (GS) will receive the LED application off, without the emission of light. The application will occur for five weeks and will occur twice weekly, on days spaced for at least 48 hours. The same will be done in conjunction with the lower limb strength training protocol. It is noteworthy that although the therapy follows the same energy values, two different pieces of equipment will be used, thus changing the wavelength, total power and power density, and the consequent coverage time and area.
The tests performed at the time of pre-application of the LED (Pre-test) will be reapplied in the same order 24 hours after the last application of the interventions. After seven days of the last application, the isokinetic evaluation, electromyography, and vertical jump evaluation will be performed. In addition, at the end of the second and fourth weeks, the volunteer will carry out an evaluation with the isokinetic dynamometer, electromyography, plethysmography, and thermography.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sao Paulo
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Ribeirao Preto, Sao Paulo, Brazil, 14049-900
- University of Sao Paulo
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- healthy individuals;
Exclusion Criteria:
- musculoskeletal injury in the last three months;
- cardiovascular diseases;
- use of anabolic, anti-inflammatory and analgesic drugs 72 hours before the evaluations;
- use of alcohol and illicit drugs during the collection period;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
SHAM_COMPARATOR: Sham Group (G-S)
The LED blanket will be positioned across the quadriceps and hamstring bilaterally, however, there will be no light emission.
However, the volunteer will perform the strength training protocol.
|
Simulation of the application of photobiomodulation therapy.
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EXPERIMENTAL: 300J Infrared Blanket LED Group (Blanket-300J)
The LED blanket with a wavelength of 940nm, energy of 300J, will be applied across the quadriceps and hamstrings bilaterally, just before the strength training protocol.
|
Photobiomodulation consists of irradiation by light in order to achieve photochemical and photophysical outcomes.
|
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EXPERIMENTAL: 300J Infrared Cluster LED Group (Cluster-300J)
The LED Cluster with a wavelength of 850 nm, energy of 300 J, will be applied to the quadriceps (5 points) and hamstrings (5 points), bilaterally, just before the strength training protocol.
|
Photobiomodulation consists of irradiation by light in order to achieve photochemical and photophysical outcomes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Difference of maximal voluntary contraction
Time Frame: 1 year
|
The study was designed to detect a difference of maximal voluntary contraction between the groups, following the interventions
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1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Carlos E Girasol, Student, University of Sao Paulo
Publications and helpful links
General Publications
- American College of Sports Medicine. American College of Sports Medicine position stand. Progression models in resistance training for healthy adults. Med Sci Sports Exerc. 2009 Mar;41(3):687-708. doi: 10.1249/MSS.0b013e3181915670.
- Ferraresi C, Beltrame T, Fabrizzi F, do Nascimento ES, Karsten M, Francisco Cde O, Borghi-Silva A, Catai AM, Cardoso DR, Ferreira AG, Hamblin MR, Bagnato VS, Parizotto NA. Muscular pre-conditioning using light-emitting diode therapy (LEDT) for high-intensity exercise: a randomized double-blind placebo-controlled trial with a single elite runner. Physiother Theory Pract. 2015 Jul;31(5):354-61. doi: 10.3109/09593985.2014.1003118. Epub 2015 Jan 14.
- Anders JJ, Lanzafame RJ, Arany PR. Low-level light/laser therapy versus photobiomodulation therapy. Photomed Laser Surg. 2015 Apr;33(4):183-4. doi: 10.1089/pho.2015.9848. No abstract available.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- DifPower
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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