- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03860766
Photobiomodulation in Different Doses on Strength Capacities and Functional Performance
Photobiomodulation With Infrared Light-emitting Diode (LED) in Different Doses on Strength Capacities and Functional Performance of Handball Players and Healthy Individuals
Study Overview
Status
Conditions
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.
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
-
Ribeirao Preto, Sao Paulo, Brazil, 14049-900
- University of Sao Paulo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Handball players with the participation of at least one official match in the last year and attend 70% of the team's activities during the current season; or
- 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: CROSSOVER
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
SHAM_COMPARATOR: Sham Group (G-S)
The LED 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.
|
An LED blanket with 267 infrared lamps with predetermined doses will be used, given a wavelength of 940nm, for 5 weeks, it will be applied by all extension of the quadriceps and hamstrings bilaterally, just before the force training protocol for the groups intervention or simulation for the sham group.
Photochemical or photophysical effects are expected from its application.
|
|
EXPERIMENTAL: 50J Infrared LED Group (G-50J)
The LED with a wavelength of 940nm, 50J power, will be applied throughout the quadriceps and hamstrings bilaterally, just before the strength training protocol.
|
An LED blanket with 267 infrared lamps with predetermined doses will be used, given a wavelength of 940nm, for 5 weeks, it will be applied by all extension of the quadriceps and hamstrings bilaterally, just before the force training protocol for the groups intervention or simulation for the sham group.
Photochemical or photophysical effects are expected from its application.
|
|
EXPERIMENTAL: 240J Infrared LED Group (G-240J)
The LED with a wavelength of 940nm, 240J power, will be applied across the quadriceps and hamstrings bilaterally, just before the strength training protocol.
|
An LED blanket with 267 infrared lamps with predetermined doses will be used, given a wavelength of 940nm, for 5 weeks, it will be applied by all extension of the quadriceps and hamstrings bilaterally, just before the force training protocol for the groups intervention or simulation for the sham group.
Photochemical or photophysical effects are expected from its application.
|
|
EXPERIMENTAL: Progressive dose infrared LED group (G-50-240J)
The LED with a wavelength of 940nm, initial energy of 50J with an increment of 38J each week to the final energy of 240J, will be applied throughout extension of the quadriceps and hamstrings bilaterally, immediately prior to the performance of the strength training protocol
|
An LED blanket with 267 infrared lamps with predetermined doses will be used, given a wavelength of 940nm, for 5 weeks, it will be applied by all extension of the quadriceps and hamstrings bilaterally, just before the force training protocol for the groups intervention or simulation for the sham group.
Photochemical or photophysical effects are expected from its application.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
difference of maximal voluntary contraction
Time Frame: 3 years
|
The study was designed to detect a difference of maximal voluntary contraction between the groups, following the interventions
|
3 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Carlos 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
- 4.188.366
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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