NCT03972007

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 18, 2019

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 3, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

March 22, 2021

Status Verified

March 1, 2021

Enrollment Period

2 years

First QC Date

May 27, 2019

Last Update Submit

March 17, 2021

Conditions

Keywords

PhysiotherapyMuscle resistanceLEDAthletic performance

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 years

Study Arms (4)

Immediate LEDT Group

EXPERIMENTAL

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.

Device: Fotobiomodulation

LEDT Group 15Min

EXPERIMENTAL

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.

Device: Fotobiomodulation

Immediate Sham Group

SHAM COMPARATOR

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.

Device: Fotobiomodulation

Sham Group 15Min

SHAM COMPARATOR

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.

Device: Fotobiomodulation

Interventions

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.

Immediate LEDT GroupImmediate Sham GroupLEDT Group 15MinSham Group 15Min

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade de São Paulo

Ribeirão Preto, São Paulo, 14049-900 Ribeirão Preto / SP, Brazil

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

Study Officials

  • Rinaldo RJ Guirro

    University of Sao Paulo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

May 27, 2019

First Posted

June 3, 2019

Study Start

May 18, 2019

Primary Completion

June 1, 2021

Study Completion

October 1, 2021

Last Updated

March 22, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

The data will be shared in manuscript form

Locations