NCT03803956

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

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

January 9, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 15, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

January 16, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2019

Completed
Last Updated

July 18, 2019

Status Verified

July 1, 2019

Enrollment Period

1 month

First QC Date

January 9, 2019

Last Update Submit

July 16, 2019

Conditions

Keywords

Photobiomodulation therapyLow-level laser therapyPerformanceSkeletal muscle recoveryHigh-level soccer playersIntense progressive running test

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Aerobic threshold.

    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.

  • Anaerobic threshold.

    Immediately after (1 minute) of ergospirometry test (progressive running test). Observation: the aerobic threshold will be measured during the progressive running test.

  • Activity of creatine kinase - CK.

    The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).

  • Activity of lactate dehydrogenase - LDH.

    The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).

  • Levels of interleukin 1 beta - IL-1b.

    The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).

  • +7 more secondary outcomes

Study Arms (2)

Active PBMT

ACTIVE COMPARATOR

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

Device: Active PBMT

Placebo PBMT

PLACEBO COMPARATOR

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

Device: Placebo PBMT

Interventions

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.

Active 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.

Placebo PBMT

Eligibility Criteria

Age18 Years - 35 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory of Phototherapy and Innovative Technologies in Health

São Paulo, 01504-001, Brazil

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ernesto Cesar Leal Junior, PhD

    University of Nove de Julho

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full professor

Study Record Dates

First Submitted

January 9, 2019

First Posted

January 15, 2019

Study Start

January 16, 2019

Primary Completion

February 16, 2019

Study Completion

February 16, 2019

Last Updated

July 18, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations