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

Primary Purpose

Muscle; Fatigue, Heart, Skeletal Muscle Recovery

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Active PBMT
Placebo PBMT
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 Photobiomodulation therapy, Low-level laser therapy, Performance, Skeletal muscle recovery, High-level soccer players, Intense progressive running test

Eligibility Criteria

18 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Laboratory of Phototherapy and Innovative Technologies in Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active PBMT

Placebo PBMT

Arm Description

Application of PBMT (Photobiomodulation Therapy) with a total dose of 850 Joules.

Application of placebo PBMT (Photobiomodulation Therapy) without any dose (0 Joule).

Outcomes

Primary Outcome Measures

Rates of oxygen uptake (VO2max).
The rates of oxygen uptake will be measured by an ergospirometry test.

Secondary Outcome Measures

Aerobic threshold.
The aerobic threshold will be measured by an ergospirometry test.
Anaerobic threshold.
The anaerobic threshold will be measured by an ergospirometry test.
Activity of creatine kinase - CK.
Muscle damage will be measured by blood samples.
Activity of lactate dehydrogenase - LDH.
Muscle damage will be measured by blood samples.
Levels of interleukin 1 beta - IL-1b.
Inflammation will be measured by blood samples.
Levels of interleukin 6 - IL-6.
Inflammation will be measured by blood samples.
Levels of tumor necrosis factor alpha - TNF-a.
Inflammation will be measured by blood samples.
Levels of Thiobarbituric acid - TBARS
Oxidative stress will be measured by blood samples.
Levels of carbonylated proteins.
Oxidative stress will be measured by blood samples.
Activity of catalase - CAT.
Oxidative stress will be measured by blood samples.
Activity of superoxidedismutase - SOD.
Oxidative stress will be measured by blood samples.
Time until exhaustion.
The time until exhaustion will be measured by the software of ergospirometry system.

Full Information

First Posted
January 9, 2019
Last Updated
July 16, 2019
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
NCT03803956
Brief Title
Infrared Low-level Laser Therapy Before Intense Progressive Running Test of High-level Soccer Players
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 16, 2019 (Actual)
Primary Completion Date
February 16, 2019 (Actual)
Study Completion Date
February 16, 2019 (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

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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).

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
Photobiomodulation therapy, Low-level laser therapy, Performance, Skeletal muscle recovery, High-level soccer players, Intense progressive running test

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active PBMT
Arm Type
Active Comparator
Arm Description
Application of PBMT (Photobiomodulation Therapy) with a total dose of 850 Joules.
Arm Title
Placebo PBMT
Arm Type
Placebo Comparator
Arm Description
Application of placebo PBMT (Photobiomodulation Therapy) without any dose (0 Joule).
Intervention Type
Device
Intervention Name(s)
Active PBMT
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Placebo PBMT
Intervention Description
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 Measure Information:
Title
Rates of oxygen uptake (VO2max).
Description
The rates of oxygen uptake will be measured by an ergospirometry test.
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.
Secondary Outcome Measure Information:
Title
Aerobic threshold.
Description
The aerobic threshold will be measured by an ergospirometry test.
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.
Title
Anaerobic threshold.
Description
The anaerobic threshold will be measured by an ergospirometry test.
Time Frame
Immediately after (1 minute) of ergospirometry test (progressive running test). Observation: the aerobic threshold will be measured during the progressive running test.
Title
Activity of creatine kinase - CK.
Description
Muscle damage will be measured by blood samples.
Time Frame
The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
Title
Activity of lactate dehydrogenase - LDH.
Description
Muscle damage will be measured by blood samples.
Time Frame
The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
Title
Levels of interleukin 1 beta - IL-1b.
Description
Inflammation will be measured by blood samples.
Time Frame
The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
Title
Levels of interleukin 6 - IL-6.
Description
Inflammation will be measured by blood samples.
Time Frame
The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
Title
Levels of tumor necrosis factor alpha - TNF-a.
Description
Inflammation will be measured by blood samples.
Time Frame
The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
Title
Levels of Thiobarbituric acid - TBARS
Description
Oxidative stress will be measured by blood samples.
Time Frame
The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
Title
Levels of carbonylated proteins.
Description
Oxidative stress will be measured by blood samples.
Time Frame
The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
Title
Activity of catalase - CAT.
Description
Oxidative stress will be measured by blood samples.
Time Frame
The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
Title
Activity of superoxidedismutase - SOD.
Description
Oxidative stress will be measured by blood samples.
Time Frame
The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
Title
Time until exhaustion.
Description
The time until exhaustion will be measured by the software of ergospirometry system.
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.

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ernesto Cesar Leal Junior, PhD
Organizational Affiliation
University of Nove de Julho
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratory of Phototherapy and Innovative Technologies in Health
City
São Paulo
ZIP/Postal Code
01504-001
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31827687
Citation
Tomazoni SS, Machado CDSM, De Marchi T, Casalechi HL, Bjordal JM, de Carvalho PTC, Leal-Junior ECP. 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-A Randomized Controlled Trial. Oxid Med Cell Longev. 2019 Nov 16;2019:6239058. doi: 10.1155/2019/6239058. eCollection 2019.
Results Reference
derived

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

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