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Effect of Light-emitting Diode (LED) Photobiomodulation Therapy on Muscular Fatigue in University Handball Athletes

Primary Purpose

Muscular Injury

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Fotobiomodulation
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscular Injury focused on measuring Physiotherapy, Muscle resistance, LED, Athletic performance

Eligibility Criteria

18 Years - 30 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Handball practitioners;
  • Absence of musculoskeletal injury in the last three months;
  • Absence of anti-inflammatory and / or analgesic drugs 72 hours before the evaluations

Exclusion Criteria:

  • Use of anabolic steroids;
  • Presence of cardiovascular disease
  • Use of alcohol and illicit drugs during the collection period

Sites / Locations

  • Universidade de São Paulo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Sham Comparator

Sham Comparator

Arm Label

Immediate LEDT Group

LEDT Group 15Min

Immediate Sham Group

Sham Group 15Min

Arm Description

The 940nm LED blanket will be positioned across the full length of the biceps brachii muscle in the dominant limb immediately before the muscle fatigue protocol.

The 940nm LED blanket will be positioned across the length of the biceps brachii muscle in the dominant limb 15 minutes before the muscle fatigue protocol.

The 940nm LED blanket will be positioned throughout the biceps brachii muscle in the dominant limb, however, it will not be ligated, with no light emission, immediately prior to the muscle fatigue protocol.

The 940nm LED blanket will be positioned throughout the biceps brachii muscle in the dominant limb, however, it will not be ligated, with no light emission, 15 minutes before the protocol of muscle fatigue.

Outcomes

Primary Outcome Measures

Difference in number of repetitions
The present study was designed to detect the difference in the number of repetitions between the groups groups, after the interventions.

Secondary Outcome Measures

Full Information

First Posted
May 27, 2019
Last Updated
March 17, 2021
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT03972007
Brief Title
Effect of Light-emitting Diode (LED) Photobiomodulation Therapy on Muscular Fatigue in University Handball Athletes
Official Title
Effect of Light-emitting Diode (LED) Photobiomodulation Therapy on Muscular Fatigue in University Handball Athletes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 18, 2019 (Actual)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
October 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Introduction: Low-intensity laser therapy (LBI) is a therapeutic modality with a large number of clinical studies in recent years, taking into account its effectiveness in tissue repair, pain control and, more recently, to increase performance. It is known that LED therapy has immediate effects. Therefore, analyzing the TLED in the infrared spectrum for acute responses at different times along with fatigue resistance capabilities, heart rate variability and biochemical response to fatigue in handball athletes becomes necessary. Objective: To analyze the acute effects of LED phototherapy (940nm) on fatigue resistance and recovery after strenuous exercises of university athletes. Method: The study sample will consist of 32 and 36 male athletes, for biceps brachii and quadriceps femoris, respectively. The athletes will be randomly assigned into four groups: Immediate TLED (TLED-I), TLED 15Min (TLED-15), Immediate Sham (Sham-I) and Sham 15Min (Sham-15). The tests performed will involve bioimpedance evaluation, blood lactate, electromyographic analysis and evaluation of maximum voluntary contraction by means of the maximal repetition test (1RM). Thus, the TLED will be applied on the muscle group to be evaluated, unilaterally, the same tests being repeated in the sequence. For analysis of the data, normality test 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.
Detailed Description
It is a blinded randomized clinical trial. The athletes will undergo a previous evaluation (day 1) comprised by anamnesis and evaluation of the bioimpedance to analyze the body composition, will still carry out the evaluation of the load for a maximum repetition. Thus, 7 days after (day 2) the previous evaluation in the times immediately after and after 15 minutes of the LED application will be carried out new tests. These will involve assessment of blood lactate, heart rate variability and electromyography. In addition, during the execution of the fatigue protocol will be collected the number of repetitions of muscle contraction and its total execution time. Due to the number of athletes that make up the university team (n = 19), cross-over will be necessary, where all athletes will initially be distributed to the 04 pre-defined groups in each subproject, and after the 7 days, they will be divided again.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscular Injury
Keywords
Physiotherapy, Muscle resistance, LED, Athletic performance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immediate LEDT Group
Arm Type
Experimental
Arm Description
The 940nm LED blanket will be positioned across the full length of the biceps brachii muscle in the dominant limb immediately before the muscle fatigue protocol.
Arm Title
LEDT Group 15Min
Arm Type
Experimental
Arm Description
The 940nm LED blanket will be positioned across the length of the biceps brachii muscle in the dominant limb 15 minutes before the muscle fatigue protocol.
Arm Title
Immediate Sham Group
Arm Type
Sham Comparator
Arm Description
The 940nm LED blanket will be positioned throughout the biceps brachii muscle in the dominant limb, however, it will not be ligated, with no light emission, immediately prior to the muscle fatigue protocol.
Arm Title
Sham Group 15Min
Arm Type
Sham Comparator
Arm Description
The 940nm LED blanket will be positioned throughout the biceps brachii muscle in the dominant limb, however, it will not be ligated, with no light emission, 15 minutes before the protocol of muscle fatigue.
Intervention Type
Device
Intervention Name(s)
Fotobiomodulation
Intervention Description
A 16x28 cm LED blanket containing 160 LEDs will be used and will use a total energy per area of 60J, with a wavelength of 940nm, just before the muscle fatigue protocol and will be applied throughout the Biceps extension.
Primary Outcome Measure Information:
Title
Difference in number of repetitions
Description
The present study was designed to detect the difference in the number of repetitions between the groups groups, after the interventions.
Time Frame
2 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Handball practitioners; Absence of musculoskeletal injury in the last three months; Absence of anti-inflammatory and / or analgesic drugs 72 hours before the evaluations Exclusion Criteria: Use of anabolic steroids; Presence of cardiovascular disease Use of alcohol and illicit drugs during the collection period
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rinaldo RJ Guirro
Organizational Affiliation
University of Sao Paulo
Official's Role
Study Director
Facility Information:
Facility Name
Universidade de São Paulo
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14049-900 Ribeirão Preto / SP
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The data will be shared in manuscript form
Citations:
PubMed Identifier
19731300
Citation
Leal Junior EC, Lopes-Martins RA, Rossi RP, De Marchi T, Baroni BM, de Godoi V, Marcos RL, Ramos L, Bjordal JM. Effect of cluster multi-diode light emitting diode therapy (LEDT) on exercise-induced skeletal muscle fatigue and skeletal muscle recovery in humans. Lasers Surg Med. 2009 Oct;41(8):572-7. doi: 10.1002/lsm.20810.
Results Reference
result
PubMed Identifier
25722067
Citation
Ferraresi C, Dos Santos RV, Marques G, Zangrande M, Leonaldo R, Hamblin MR, Bagnato VS, Parizotto NA. Light-emitting diode therapy (LEDT) before matches prevents increase in creatine kinase with a light dose response in volleyball players. Lasers Med Sci. 2015 May;30(4):1281-7. doi: 10.1007/s10103-015-1728-3. Epub 2015 Feb 27.
Results Reference
result
PubMed Identifier
21814736
Citation
de Almeida P, Lopes-Martins RA, De Marchi T, Tomazoni SS, Albertini R, Correa JC, Rossi RP, Machado GP, da Silva DP, Bjordal JM, Leal Junior EC. Red (660 nm) and infrared (830 nm) low-level laser therapy in skeletal muscle fatigue in humans: what is better? Lasers Med Sci. 2012 Mar;27(2):453-8. doi: 10.1007/s10103-011-0957-3. Epub 2011 Jul 22.
Results Reference
result

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Effect of Light-emitting Diode (LED) Photobiomodulation Therapy on Muscular Fatigue in University Handball Athletes

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