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Low Level Laser Therapy in Muscle Fatigue and Muscle Recovery (LLLT)

Primary Purpose

Muscle; Fatigue, Heart, Skeletal Muscle Recovery

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Low Level Laser (LLL)
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Muscle; Fatigue, Heart focused on measuring LLLT, muscle fatigue and recovery, phototherapy parameter

Eligibility Criteria

18 Years - 35 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • professional soccer players aged between 18 and 35 years old;
  • not presenting historical musculoskeletal injury in regions of the hip and knee in the 2 months preceding the study;
  • not making use of pharmacological agents and/or nutritional supplements;
  • participating with minimum frequency of 80% of the training team

Exclusion Criteria:

  • athletes who experience musculoskeletal injury during the study;
  • athletes who for whatever reason have their training routine changed with respect to the rest of the team during the course of study.

Sites / Locations

  • Nove de Julho University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Placebo Low Level Laser

2 Joules Low Level Laser

6 Joules Low Level Laser Therapy

10 Joules Low Level Therapy

Power of 100mW

Power of 400mW

Arm Description

Application of low level laser without any dose (0 Joule) before strenuous exercise. A laser device with a cluster of 5 diodes (810 nm, 200 mW) each diode was used for this study.

Application of 2 Joules of Low Level Laser Therapy before strenuous exercise with a cluster of 5 diode (810 nm, 200 mW each diode).

Application of 6 Joules of Low Level Laser Therapy before strenuous exercise with a cluster of 5 diode (810 nm, 200 mW each diode).

Application of 10 Joules of Low Level Laser Therapy before strenuous exercise with a cluster of 5 diode (810 nm, 200 mW each diode).

After assigning ideal dose of application it was delimited two experimental groups which was irradiated with the dose established by the first part of the study and power of 100mW.

After assigning ideal dose of application it was delimited two experimental groups which were irradiated with the dose established by the first part of the study and power of 400mW.

Outcomes

Primary Outcome Measures

Exercise performance (MVC and peak torque)
The investigators used an isokinetic dynamometer to assess muscle function and the execution of the exercise protocol, because this tool is currently recognized as the most reliable, reliability and reproducibility for measuring the performance musculoskeletal. The maximum voluntary contraction (MVC) was performed before the exercise protocol and repeated 1 minute, 1 hour, 24, 48, 72 and 96 hours after the eccentric contraction protocol. The peak torque was measured after evaluation of muscular pain, blood tests, stretching and warming, MVC and application of a predetermined dose of low level therapy (LLLT). It was done after 3 minutes of LLLT application through execution of a eccentric contraction of 5 series of 15 repetitions. After the execution of the exercise protocol it was repeated the collection of blood samples, measuring DOMS and muscle function test (MVC) in 1 minute, 1 hour, 24 hours, 48 hours, 72 hours and 96 hours from the protocol.

Secondary Outcome Measures

Blood tests (composite measures)
Biochemical markers of muscle damage (CK and LDH), inflammation (IL-1, IL-6 and tumor necrosis factor(TNF)-alpha) and oxidative stress (TBARS, CAT, SOD and carbonylated proteins). The analysis were performed before exercise protocols, after 1 minute, and 1, 24, 48, 72 and 96 hours after the end of exercise protocol.

Full Information

First Posted
April 24, 2013
Last Updated
December 4, 2014
Sponsor
University of Nove de Julho
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01844271
Brief Title
Low Level Laser Therapy in Muscle Fatigue and Muscle Recovery
Acronym
LLLT
Official Title
Low Level Laser Therapy in Muscle Fatigue and Muscle Recovery After Exercise: What is the Ideal Dose?
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Muscle fatigue and muscle recovery after exercise are recent areas of research involving Low Level Laser Therapy (LLLT) and many factors remain unknown, such as optimal doses, power and application parameters, mechanisms of action, effects on long-term exercise and the long-term effects on skeletal muscle recovery. The present research project aims to assess the effects of long-term recovery of LLLT in skeletal muscle after exercise and identify the optimal dose application of LLLT. After defining the best dose of application, we recruited two groups which will be irradiated with different power, 100mW and 400mW in order to seek the optimal parameter of low level laser therapy in performance. The investigators believed that the Low Level Laser Therapy can delay the physiological process of muscle fatigue, reduce injury or skeletal muscle microdamage arising from physical effort and accelerate muscle recovery after exercise.
Detailed Description
To achieve the proposed objectives it was performed a randomized, double-blinded, placebo-controlled trial, with voluntary participation of high-level soccer athletes. Participants received an application of low level laser prior to execution of a strenuous exercise. It was used a laser with a cluster of 5 diodes (810 nm, 200 mW each diode) with different doses (placebo, 2J, 6J, 10J) and power of 200mW. In a second step, with the optimal dose already defined, this was used to be applied with different powers in two experimental groups, 100mW and 400mW. The investigators analysed parameters related to volunteers exercise performance (torque peak / maximum voluntary contraction), delayed onset muscle soreness, and biochemical markers of muscle damage (CK and LDH), inflammation (interleukin 1 and 6, alpha tumoral necrosis factor) and oxidative stress (TBARS, CAT, SOD and carbonylated proteins). The analysis was performed before exercise protocols, after 1 minute, and 1, 24, 48, 72 and 96 hours after the end of exercise protocol in both parts of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle; Fatigue, Heart, Skeletal Muscle Recovery
Keywords
LLLT, muscle fatigue and recovery, phototherapy parameter

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo Low Level Laser
Arm Type
Placebo Comparator
Arm Description
Application of low level laser without any dose (0 Joule) before strenuous exercise. A laser device with a cluster of 5 diodes (810 nm, 200 mW) each diode was used for this study.
Arm Title
2 Joules Low Level Laser
Arm Type
Experimental
Arm Description
Application of 2 Joules of Low Level Laser Therapy before strenuous exercise with a cluster of 5 diode (810 nm, 200 mW each diode).
Arm Title
6 Joules Low Level Laser Therapy
Arm Type
Experimental
Arm Description
Application of 6 Joules of Low Level Laser Therapy before strenuous exercise with a cluster of 5 diode (810 nm, 200 mW each diode).
Arm Title
10 Joules Low Level Therapy
Arm Type
Experimental
Arm Description
Application of 10 Joules of Low Level Laser Therapy before strenuous exercise with a cluster of 5 diode (810 nm, 200 mW each diode).
Arm Title
Power of 100mW
Arm Type
Experimental
Arm Description
After assigning ideal dose of application it was delimited two experimental groups which was irradiated with the dose established by the first part of the study and power of 100mW.
Arm Title
Power of 400mW
Arm Type
Experimental
Arm Description
After assigning ideal dose of application it was delimited two experimental groups which were irradiated with the dose established by the first part of the study and power of 400mW.
Intervention Type
Device
Intervention Name(s)
Low Level Laser (LLL)
Intervention Description
Comparison of different dosages of a Low Level Laser applied in six different locations of the knee extensor muscles of the lower limb non-dominant before a strenuous exercise. We performed stretching and warming up of the muscles involved, assessment of muscle pain, withdrawal of blood sample, test muscle function (MVC), application of dose of low level laser designated for each volunteer (0, 2, 6 or 10), performing eccentric contractions protocol in isokinetic dynamometer . After the protocol we evaluated muscle function, the DOMS, and blood analyzes in 1 minute, 1 hour, 24 hours, 48 hours 72 hours and 96 hours. In a second stage, the optimal dose defined by the first part of the study will be tested in two different powers, 100 and 400mW. The study was repeated in two experimental groups using the optimal dose established and the powers of 100 and 400mW that was randomly distributed in groups.
Primary Outcome Measure Information:
Title
Exercise performance (MVC and peak torque)
Description
The investigators used an isokinetic dynamometer to assess muscle function and the execution of the exercise protocol, because this tool is currently recognized as the most reliable, reliability and reproducibility for measuring the performance musculoskeletal. The maximum voluntary contraction (MVC) was performed before the exercise protocol and repeated 1 minute, 1 hour, 24, 48, 72 and 96 hours after the eccentric contraction protocol. The peak torque was measured after evaluation of muscular pain, blood tests, stretching and warming, MVC and application of a predetermined dose of low level therapy (LLLT). It was done after 3 minutes of LLLT application through execution of a eccentric contraction of 5 series of 15 repetitions. After the execution of the exercise protocol it was repeated the collection of blood samples, measuring DOMS and muscle function test (MVC) in 1 minute, 1 hour, 24 hours, 48 hours, 72 hours and 96 hours from the protocol.
Time Frame
Maximum voluntary contraction (MVC) was performed before the exercise protocol and repeted 1 minute, 1 hour, 24, 48, 72 and 96 hours after the eccentric contraction protocol. The peak torque was performed after 3 minutes of LLLT application.
Secondary Outcome Measure Information:
Title
Blood tests (composite measures)
Description
Biochemical markers of muscle damage (CK and LDH), inflammation (IL-1, IL-6 and tumor necrosis factor(TNF)-alpha) and oxidative stress (TBARS, CAT, SOD and carbonylated proteins). The analysis were performed before exercise protocols, after 1 minute, and 1, 24, 48, 72 and 96 hours after the end of exercise protocol.
Time Frame
Analysis of biochemical markers of muscle damage, inflammation and oxidative stress before exercise protocols, after 1 minute, and 1, 24, 48, 72 and 96 hours after the end of exercise protocol.
Other Pre-specified Outcome Measures:
Title
Delayed onset muscle soreness (DOMS)
Description
Assessed through an analog algometer always by the same investigator.
Time Frame
The analysis were performed before exercise protocols, after 1 minute, and 1, 24, 48, 72 and 96 hours after the end of exercise protocol.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: professional soccer players aged between 18 and 35 years old; not presenting historical musculoskeletal injury in regions of the hip and knee in the 2 months preceding the study; not making use of pharmacological agents and/or nutritional supplements; participating with minimum frequency of 80% of the training team Exclusion Criteria: athletes who experience musculoskeletal injury during the study; athletes who for whatever reason have their training routine changed with respect to the rest of the team during the course of study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adriane A Vanin, PT
Organizational Affiliation
Nove de Julho University
Official's Role
Study Chair
Facility Information:
Facility Name
Nove de Julho University
City
São Paulo
State/Province
SP
ZIP/Postal Code
01504-001
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
20602109
Citation
Baroni BM, Leal Junior EC, De Marchi T, Lopes AL, Salvador M, Vaz MA. Low level laser therapy before eccentric exercise reduces muscle damage markers in humans. Eur J Appl Physiol. 2010 Nov;110(4):789-96. doi: 10.1007/s00421-010-1562-z. Epub 2010 Jul 3.
Results Reference
result
PubMed Identifier
24576321
Citation
de Oliveira AR, Vanin AA, De Marchi T, Antonialli FC, Grandinetti Vdos S, de Paiva PR, Albuquerque Pontes GM, Santos LA, Aleixo Junior Ide O, de Carvalho Pde T, Bjordal JM, Leal-Junior EC. What is the ideal dose and power output of low-level laser therapy (810 nm) on muscle performance and post-exercise recovery? Study protocol for a double-blind, randomized, placebo-controlled trial. Trials. 2014 Feb 27;15:69. doi: 10.1186/1745-6215-15-69.
Results Reference
derived

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Low Level Laser Therapy in Muscle Fatigue and Muscle Recovery

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