Clinical trial NCT03972007: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Muscular Injury
Keywords: Physiotherapy
Muscle resistance
LED
Athletic performance
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2019-06-03
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Difference in number of repetitions
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Universidade de São Paulo
state: São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Rinaldo RJ Guirro
role: STUDY_DIRECTOR
References:
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.
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.
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.