Clinical trial NCT03695458: Local and Systemic Effects of Photobiomodulation Therapy on Muscle Performance and Recovery Post-exercise.
Official title: Local and Systemic Effects of Photobiomodulation Therapy on Muscle Performance and Recovery Post-exercise.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Phototherapy
Low-level Laser Therapy
Systemic
Keywords: phototherapy
systemic effect
recovery
performance
photobiomodulation
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2018-10-04
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, triple-blind and placebo-controlled
Primary purpose: TREATMENT

Brief summary: Recent studies with photobiomodulation therapy have shown positive results in delaying skeletal muscle fatigue and improving performance through levels of biochemical markers and variables related to exercise when this therapy was applied before exercise. Some studies suggest that photobiomodulation therapy has systemic effects, but it is not known whether therapy exerts any systemic effects on human skeletal muscle. With this factor in mind, this research aims to verify the local and systemic effects of phototherapy on muscle performance and recovery after exercise in healthy male participants. This research consists in a randomized, triple-blinded, placebo-controlled trial, with participation of 30 healthy subjects. Will be analyzed parameters related to exercise performance (peak torque in the maximum voluntary contraction test- MVC), delayed onset muscle soreness (DOMS) by visual analogue scale (VAS), and biochemical marker of muscle damage (CK) and blood Lactate (BL). The analysis will be performed before exercise protocol (baseline), after 1 minute of the exercise, and 1, 24, 48 and 72 hours after the end of exercise protocol

Detailed description: A total of 30 healthy male non-athletes, between 18-35 years, will be randomly divided into 3 experimental groups, named "Placebo (Control)", "Local", "Systemic", according to the lower limb who will receive photobiomodulation therapy. Firstly, a blood collection will be performed by a nurse with sterile and disposable materials for posterior analysis of creatine kinase (CK) and Blood Lactate (BL). Delayed onset muscle soreness (DOMS) will be assessed with the Visual Analogue Scale (VAS) using a 10 cm line. Participants will be instructed to mark the line where their pain best fits at that time (0=no pain, 10=worst pain).Then, the maximum voluntary contraction test (MVC) will be performed, which will consist in performing 3 times of 5-sec isometric contractions of the non-dominant knee extensors in the isokinetic dynamometer device. During the execution of the MVC, the participants will be verbally encouraged to exert the greatest force at that moment. Photobiomodulation therapy will be applied 2 minutes after the MVC test in six points of non-dominant anterior thigh muscle. After irradiation, participants will perform the protocol of eccentric contractions. This protocol will be performed to induce muscle fatigue by resisting the movement of knee flexion in 5 series of 15 repetitions with 30 seconds -intervals (eccentric contractions). Assessments (blood collection, VAS and MVC) will be performed before warm-up (baseline), 1 minute after exercise protocol and 1, 24, 48 and 72 hours after eccentric exercise protocol.

Eligibility criteria: Inclusion Criteria:

* Healthy individuals,
* Non-athletes
* Those who practice physical activity at maximal of once a week
* Between 18 and 35 years old,
* Male
* No history of musculoskeletal injury in the hip or knee previous two months of the study.
* Not be taking pharmacological agents and / or nutritional supplements, and should have frequency of 100% in all days of data collection.

Exclusion Criteria:

* Individuals who present musculoskeletal injury during the study
* Chronic joint disease in the non-dominant lower limb

Primary outcomes:
measure: Maximum Voluntary Contraction
timeFrame: baseline
measure: Maximum Voluntary Contraction
timeFrame: 1 minute after the protocol of eccentric contractions
measure: Maximum Voluntary Contraction
timeFrame: 1 hour after the protocol of eccentric contractions
measure: Maximum Voluntary Contraction
timeFrame: 24 hours after the protocol of eccentric contractions
measure: Maximum Voluntary Contraction
timeFrame: 48 hours after the protocol of eccentric contractions
measure: Maximum Voluntary Contraction
timeFrame: 72 hours after the protocol of eccentric contractions
Secondary outcomes:
measure: enzymatic activity of creatine kinase (CK)
timeFrame: baseline
measure: enzymatic activity of creatine kinase (CK)
timeFrame: 1 minute after the protocol of eccentric contractions
measure: enzymatic activity of creatine kinase (CK)
timeFrame: 1 hour after the protocol of eccentric contractions
measure: enzymatic activity of creatine kinase (CK)
timeFrame: 24 hours after the protocol of eccentric contractions
measure: enzymatic activity of creatine kinase (CK)
timeFrame: 48 hours after the protocol of eccentric contractions
measure: enzymatic activity of creatine kinase (CK)
timeFrame: 72 hours after the protocol of eccentric contractions
measure: Blood Lactate
timeFrame: baseline
measure: Blood Lactate
timeFrame: 1 minute after the protocol of eccentric contractions
measure: Blood Lactate
timeFrame: 1 hour after the protocol of eccentric contractions
measure: Blood Lactate
timeFrame: 24 hours after the protocol of eccentric contractions
measure: Blood Lactate
timeFrame: 48 hours after the protocol of eccentric contractions
measure: Blood Lactate
timeFrame: 72 hours after the protocol of eccentric contractions
measure: Delayed onset muscle soreness (DOMS)
timeFrame: baseline
measure: Delayed onset muscle soreness (DOMS)
timeFrame: 1 minute after the protocol of eccentric contractions
measure: Delayed onset muscle soreness (DOMS)
timeFrame: 1 hour after the protocol of eccentric contractions
measure: Delayed onset muscle soreness (DOMS)
timeFrame: 24 hours after the protocol of eccentric contractions
measure: Delayed onset muscle soreness (DOMS)
timeFrame: 48 hours after the protocol of eccentric contractions
measure: Delayed onset muscle soreness (DOMS)
timeFrame: 72 hours after the protocol of eccentric contractions
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Universidade Nove de Julho
state: SP
Study officials:
affiliation: University of Nove de Julho
name: Caroline M Machado, 1
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vanin AA, Miranda EF, Machado CS, de Paiva PR, Albuquerque-Pontes GM, Casalechi HL, de Tarso Camillo de Carvalho P, Leal-Junior EC. What is the best moment to apply phototherapy when associated to a strength training program? A randomized, double-blinded, placebo-controlled trial : Phototherapy in association to strength training. Lasers Med Sci. 2016 Nov;31(8):1555-1564. doi: 10.1007/s10103-016-2015-7. Epub 2016 Jul 1.
citation: Miranda EF, Vanin AA, Tomazoni SS, Grandinetti Vdos S, de Paiva PR, Machado Cdos S, Monteiro KK, Casalechi HL, de Tarso P, de Carvalho C, Leal-Junior EC. Using Pre-Exercise Photobiomodulation Therapy Combining Super-Pulsed Lasers and Light-Emitting Diodes to Improve Performance in Progressive Cardiopulmonary Exercise Tests. J Athl Train. 2016 Feb;51(2):129-35. doi: 10.4085/1062-6050-51.3.10. Epub 2016 Mar 4.
citation: Antonialli FC, De Marchi T, Tomazoni SS, Vanin AA, dos Santos Grandinetti V, de Paiva PR, Pinto HD, Miranda EF, de Tarso Camillo de Carvalho P, Leal-Junior EC. Phototherapy in skeletal muscle performance and recovery after exercise: effect of combination of super-pulsed laser and light-emitting diodes. Lasers Med Sci. 2014 Nov;29(6):1967-76. doi: 10.1007/s10103-014-1611-7. Epub 2014 Jun 19.
citation: Machado CDSM, Casalechi HL, Vanin AA, de Azevedo JB, de Carvalho PTC, Leal-Junior ECP. Does photobiomodulation therapy combined to static magnetic field (PBMT-sMF) promote ergogenic effects even when the exercised muscle group is not irradiated? A randomized, triple-blind, placebo-controlled trial. BMC Sports Sci Med Rehabil. 2020 Aug 26;12:49. doi: 10.1186/s13102-020-00197-6. eCollection 2020.