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Infrared Low-level Laser Therapy Before Intense Progressive Running Test of High-level Soccer Players

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03803956
Recruitment Status : Completed
First Posted : January 15, 2019
Last Update Posted : July 18, 2019
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Ernesto Cesar Pinto Leal Junior, University of Nove de Julho

Brief Summary:

Photobiomodulation therapy (PBMT) has recently been used to alleviate postexercise muscle fatigue and enhance muscle recovery, demonstrating positive results. A previous study by the investigator's research group demonstrated the optimal dose and the optimal output power (100 mW) for an infrared wavelength (810 nm). However, the effects of optimized PBMT on performance and post-exercise recovery in high-level soccer players, to date have not been evaluated.

The present research project aims to evaluate the effects of PBMT (using low-level laser therapy) applied before a progressive running test on functional, muscle damage, inflammatory and oxidative stress markers in high-level soccer players.


Condition or disease Intervention/treatment Phase
Muscle; Fatigue, Heart Skeletal Muscle Recovery Device: Active PBMT Device: Placebo PBMT Not Applicable

Detailed Description:

To achieve the proposed objective it will perform a randomized, crossover triple-blinded, placebo-controlled trial, with high-level soccer players as volunteers.

Twenty-two volunteers will be randomly allocated to two intervention groups: active or placebo PBMT before a progressive running test (ergospirometry test).

The blood samples for biochemical analysis will be obtained before and after a progressive running test, and another outcomes (functional) will be obtained during the test.

The data will be collected by a blind assessor. The statistical analysis will follow the intention-to-treat principles and data on functional analysis will be analyzed using the paired and two-tailed t-student test. Data on biochemical analysis will be analyzed using two-way ANOVA, followed by Bonferroni post hoc test.

The investigators will analyze: functional aspects (rates of oxygen uptake -VO2max (absolute and relative), aerobic and anaerobic threshold and time until exhaustion), muscle damage (creatine-kinase -CK and lactate dehydrogenase -LDH), inflammatory markers (IL-1β, IL-6 and TNF-α) and oxidative stress markers (Thiobarbituric acid -TBARS, catalase - CAT, superoxidedismutase - SOD and carbonylated proteins).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: The volunteers who will receive active PBMT in the first stage of the study, will receive placebo PBMT in the second stage, while the volunteers that will receive placebo PBMT in the first stage, will receive active PBMT in the second stage of the study.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: The mode of intervention (active or placebo photobiomodulation) will be coded by an independent researcher. The randomization schedule will contain only codes (not the actual intervention). The output from the laser device is exactly the same from either the active or the placebo interventions. These features will guarantee that participants, therapists and outcomes assessor will be blinded to the treatment arms.
Primary Purpose: Prevention
Official Title: Infrared Low-level Laser Therapy (Photobiomodulation Therapy) Before Intense Progressive Running Test of High-level Soccer Players: Effects on Functional, Muscle Damage, Inflammatory and Oxidative Stress Markers
Actual Study Start Date : January 16, 2019
Actual Primary Completion Date : February 16, 2019
Actual Study Completion Date : February 16, 2019

Arm Intervention/treatment
Active Comparator: Active PBMT
Application of PBMT (Photobiomodulation Therapy) with a total dose of 850 Joules.
Device: Active PBMT
The PBMT will be performed using the dose of 10J per diode, previously determined by a previous study and power output of 100 mW per diode, also previously determined. PBMT will be performed at nine different sites of the knee extensor muscles, six different sites of the knee flexor muscles and two different sites of the plantar flex muscles. As the cluster will be 5 diodes and 17 different sites will be irradiated, a total of 85 points will be irradiated in each lower limb, a total of 850 J of energy. The active PBMT will be performed before a progressive running test.

Placebo Comparator: Placebo PBMT
Application of placebo PBMT (Photobiomodulation Therapy) without any dose (0 Joule).
Device: Placebo PBMT
The placebo PBMT will per performed using the dose of 0 J per diode. Placebo PBMT will be performed at nine different sites of the knee extensor muscles, six different sites of the knee flexor muscles and two different sites of the plantar flex muscles. As the cluster will be 5 diodes and 17 different sites will be irradiated, a total of 85 points will be irradiated in each lower limb, a total of 0 J of energy. To ensure blinding, the device emitted the same sound regardless of the programmed mode (active or placebo PBMT). The placebo PBMT will be performed before a progressive running test.




Primary Outcome Measures :
  1. Rates of oxygen uptake (VO2max). [ Time Frame: Immediately after (1 minute) of ergospirometry test. Observation: the rates of oxygen uptake (relative and absolute) will be measured during the progressive running test. ]
    The rates of oxygen uptake will be measured by an ergospirometry test.


Secondary Outcome Measures :
  1. Aerobic threshold. [ Time Frame: Immediately after (1 minute) of ergospirometry test. Observation: the aerobic threshold will be measured during the progressive runThe aerobic and anaerobic threshold will be measured during the progressive running test. ]
    The aerobic threshold will be measured by an ergospirometry test.

  2. Anaerobic threshold. [ Time Frame: Immediately after (1 minute) of ergospirometry test (progressive running test). Observation: the aerobic threshold will be measured during the progressive running test. ]
    The anaerobic threshold will be measured by an ergospirometry test.

  3. Activity of creatine kinase - CK. [ Time Frame: The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test). ]
    Muscle damage will be measured by blood samples.

  4. Activity of lactate dehydrogenase - LDH. [ Time Frame: The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test). ]
    Muscle damage will be measured by blood samples.

  5. Levels of interleukin 1 beta - IL-1b. [ Time Frame: The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test). ]
    Inflammation will be measured by blood samples.

  6. Levels of interleukin 6 - IL-6. [ Time Frame: The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test). ]
    Inflammation will be measured by blood samples.

  7. Levels of tumor necrosis factor alpha - TNF-a. [ Time Frame: The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test). ]
    Inflammation will be measured by blood samples.

  8. Levels of Thiobarbituric acid - TBARS [ Time Frame: The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test). ]
    Oxidative stress will be measured by blood samples.

  9. Levels of carbonylated proteins. [ Time Frame: The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test). ]
    Oxidative stress will be measured by blood samples.

  10. Activity of catalase - CAT. [ Time Frame: The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test). ]
    Oxidative stress will be measured by blood samples.

  11. Activity of superoxidedismutase - SOD. [ Time Frame: The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test). ]
    Oxidative stress will be measured by blood samples.

  12. Time until exhaustion. [ Time Frame: Immediately after (1 minute) of ergospirometry test (progressive running test). Observation: the time until exhaustion will be measured during the progressive running test. ]
    The time until exhaustion will be measured by the software of ergospirometry system.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • High-level soccer players;
  • Age between 18 and 35 years;
  • Male gender;
  • Minimum of 80% participation in team practice sessions;
  • Agreement to participate through signed statement of informed consent.

Exclusion Criteria:

  • History of musculoskeletal injury to hips or knees in previous 2 months;
  • Use of pharmacological agents or nutritional supplements;
  • Smokers and alcoholics;
  • Occurrence of musculoskeletal injury during the trial;
  • Any change in practice routine in relation to rest of the team during the trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03803956


Locations
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Brazil
Laboratory of Phototherapy and Innovative Technologies in Health
São Paulo, Brazil, 01504-001
Sponsors and Collaborators
University of Nove de Julho
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
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Principal Investigator: Ernesto Cesar Leal Junior, PhD University of Nove de Julho
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ernesto Cesar Pinto Leal Junior, Full professor, University of Nove de Julho
ClinicalTrials.gov Identifier: NCT03803956    
Other Study ID Numbers: 397774/2011
First Posted: January 15, 2019    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ernesto Cesar Pinto Leal Junior, University of Nove de Julho:
Photobiomodulation therapy
Low-level laser therapy
Performance
Skeletal muscle recovery
High-level soccer players
Intense progressive running test
Additional relevant MeSH terms:
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Fatigue