Photobiomodulation in Different Doses on Strength Capacities and Functional Performance

July 19, 2021 updated by: Rinaldo Roberto de Jesus Guirro, University of Sao Paulo

Photobiomodulation With Infrared Light-emitting Diode (LED) in Different Doses on Strength Capacities and Functional Performance of Handball Players and Healthy Individuals

Background: Photobiomodulation has been explored for years, with wide clinical use for wound healing and analgesia in varied orthopedic conditions, but the number of research and clinical use has increased during the last decade. Furthermore, considering the performance, the current literature is conflicting and restricted, with divergences in wavelength, power and energy density applied. Therefore, analyze different doses for a answer in short and long time, associated with capacities of strength, fatigue resistance and functional performance of handball players and healthy individuals becomes necessary. Objective: To analyze the effects of the application of LED photobiomodulation on the capacities of strength, functional efficiency, temperature and fatigue resistance of handball players and healthy individuals. Method: The study sample will be composed of 56 male individuals randomly allocated into four groups: LED 50J (G-50J), LED 240J (G-240J), LED 50-240J (G-50-240J) - progressive dose and Sham (G-S). The volunteers will be submitted to an evaluation of muscle performance and functional performance, metabolic, and physiological evaluation. After initial tests, in five consecutive weeks, the LEDT (940nm - infrared) will be applied to the quadriceps femoris muscle and hamstrings, bilaterally, associated with a muscle strength protocol. After 24 hours of the last application TLED, the tests will be repeated. Seven days after the last intervention will be performed a follow-up. For analysis, normality tests will be used to verify the distribution and adequate statistical tests for the appropriate intra and intergroup comparisons, being considered two factors in the comparisons, time, and group. A significance level of 5% will be adopted.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

56

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

    • Sao Paulo
      • Ribeirao Preto, Sao Paulo, Brazil, 14049-900
        • University of Sao Paulo

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 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

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

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: 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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Carlos Girasol, Student, University of Sao Paulo

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 (ACTUAL)

July 8, 2020

Primary Completion (ACTUAL)

July 19, 2021

Study Completion (ACTUAL)

July 19, 2021

Study Registration Dates

First Submitted

February 28, 2019

First Submitted That Met QC Criteria

February 28, 2019

First Posted (ACTUAL)

March 4, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 21, 2021

Last Update Submitted That Met QC Criteria

July 19, 2021

Last Verified

July 1, 2021

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)?

NO

IPD Plan Description

The datas will be sharing in form of manuscript.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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