NCT01844271

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 1, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

December 8, 2014

Status Verified

December 1, 2014

Enrollment Period

4 months

First QC Date

April 24, 2013

Last Update Submit

December 4, 2014

Conditions

Keywords

LLLTmuscle fatigue and recoveryphototherapy parameter

Outcome Measures

Primary Outcomes (1)

  • 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.

    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 Outcomes (1)

  • Blood tests (composite measures)

    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 Outcomes (1)

  • Delayed onset muscle soreness (DOMS)

    The analysis were performed before exercise protocols, after 1 minute, and 1, 24, 48, 72 and 96 hours after the end of exercise protocol.

Study Arms (6)

Placebo Low Level Laser

PLACEBO COMPARATOR

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.

Device: Low Level Laser (LLL)

2 Joules Low Level Laser

EXPERIMENTAL

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

Device: Low Level Laser (LLL)

6 Joules Low Level Laser Therapy

EXPERIMENTAL

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

Device: Low Level Laser (LLL)

10 Joules Low Level Therapy

EXPERIMENTAL

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

Device: Low Level Laser (LLL)

Power of 100mW

EXPERIMENTAL

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.

Device: Low Level Laser (LLL)

Power of 400mW

EXPERIMENTAL

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.

Device: Low Level Laser (LLL)

Interventions

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.

10 Joules Low Level Therapy2 Joules Low Level Laser6 Joules Low Level Laser TherapyPlacebo Low Level LaserPower of 100mWPower of 400mW

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nove de Julho University

São Paulo, São Paulo, 01504-001, Brazil

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Fatigue

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Officials

  • Adriane A Vanin, PT

    Nove de Julho University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Low level laser therapy in muscle fatigue and muscle recovery after exercise: what is the ideal dose?

Study Record Dates

First Submitted

April 24, 2013

First Posted

May 1, 2013

Study Start

May 1, 2013

Primary Completion

September 1, 2013

Study Completion

December 1, 2013

Last Updated

December 8, 2014

Record last verified: 2014-12

Locations