Infrared Low-level Laser Therapy Before Intense Progressive Running Test of High-level Soccer Players
1 other identifier
interventional
22
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2019
Shorter than P25 for not_applicable
1 active site
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
CompletedFirst Posted
Study publicly available on registry
January 15, 2019
CompletedStudy Start
First participant enrolled
January 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 16, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 16, 2019
CompletedJuly 18, 2019
July 1, 2019
1 month
January 9, 2019
July 16, 2019
Conditions
Keywords
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 COMPARATORApplication of PBMT (Photobiomodulation Therapy) with a total dose of 850 Joules.
Placebo PBMT
PLACEBO COMPARATORApplication of placebo PBMT (Photobiomodulation Therapy) without any dose (0 Joule).
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.
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.
Eligibility Criteria
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
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.
PMID: 31827687DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ernesto Cesar Leal Junior, PhD
University of Nove de Julho
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
- 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