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

Muscle; Fatigue, Heart Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03803956
• Other study ID #: 397774/2011
• Status: Completed
• Phase: N/A
• Start date: January 16, 2019
• Est. completion date: February 16, 2019

Study information

• Verified date: July 2019
• Source: University of Nove de Julho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: February 16, 2019
• Est. primary completion date: February 16, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatigue
• Muscle; Fatigue, Heart
• Skeletal Muscle Recovery

Intervention

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 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.

Locations

Country	Name	City	State
Brazil	Laboratory of Phototherapy and Innovative Technologies in Health	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Nove de Julho	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of oxygen uptake (VO2max).	The rates of oxygen uptake will be measured by an ergospirometry test.	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	Aerobic threshold.	The aerobic threshold will be measured by an ergospirometry test.	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.
Secondary	Anaerobic threshold.	The anaerobic threshold will be measured by an ergospirometry test.	Immediately after (1 minute) of ergospirometry test (progressive running test). Observation: the aerobic threshold will be measured during the progressive running test.
Secondary	Activity of creatine kinase - CK.	Muscle damage will be measured by blood samples.	The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
Secondary	Activity of lactate dehydrogenase - LDH.	Muscle damage will be measured by blood samples.	The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
Secondary	Levels of interleukin 1 beta - IL-1b.	Inflammation will be measured by blood samples.	The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
Secondary	Levels of interleukin 6 - IL-6.	Inflammation will be measured by blood samples.	The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
Secondary	Levels of tumor necrosis factor alpha - TNF-a.	Inflammation will be measured by blood samples.	The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
Secondary	Levels of Thiobarbituric acid - TBARS	Oxidative stress will be measured by blood samples.	The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
Secondary	Levels of carbonylated proteins.	Oxidative stress will be measured by blood samples.	The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
Secondary	Activity of catalase - CAT.	Oxidative stress will be measured by blood samples.	The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
Secondary	Activity of superoxidedismutase - SOD.	Oxidative stress will be measured by blood samples.	The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
Secondary	Time until exhaustion.	The time until exhaustion will be measured by the software of ergospirometry system.	Immediately after (1 minute) of ergospirometry test (progressive running test). Observation: the time until exhaustion will be measured during the progressive running test.