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Completed

NCT Number: NCT03803956

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

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.

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Key information

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Laboratory of Phototherapy and Innovative Technologies in Health

São Paulo, 01504-001, Brazil

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Active PBMT

Device

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 PBMT

Device

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Nove de Julho

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 15, 2019
Registry last updated
Jul 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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