Muscle; Fatigue, HeartNCT03803956
Infrared Low-level Laser Therapy Before Intense Progressive Running Test of High-level Soccer Players
A study testing Active PBMT in people with Muscle; Fatigue, Heart and Skeletal Muscle Recovery, run by University of Nove de Julho at 1 site in Brazil.
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). Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle; Fatigue, Heart, Skeletal Muscle Recovery
- What is being tested?
- Active PBMT
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteBrazil
- Study dates
- 16 Jan 2019to 16 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Laboratory of Phototherapy and Innovative Technologies in Health
São Paulo, 01504-001
About this study
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
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.
Read the 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).
- Conditions
- Muscle; Fatigue, Heart, Skeletal Muscle Recovery
- Being tested
- Active PBMT, Placebo PBMT
- Keywords
- Photobiomodulation therapy, Low-level laser therapy, Performance, Skeletal muscle recovery, High-level soccer players, Intense progressive running test
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active PBMTDevice
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 PBMTDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Active PBMT | Active comparator | Application of PBMT (Photobiomodulation Therapy) with a total dose of 850 Joules. Receives: Device: Active PBMT |
| Placebo PBMT | Placebo comparator | Application of placebo PBMT (Photobiomodulation Therapy) without any dose (0 Joule). Receives: Device: Placebo PBMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of oxygen uptake (VO2max).
The rates of oxygen uptake will be measured by an ergospirometry test.
Measured: 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.
The aerobic threshold will be measured by an ergospirometry test.
Measured: 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.
The anaerobic threshold will be measured by an ergospirometry test.
Measured: 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.
Muscle damage will be measured by blood samples.
Measured: The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
Activity of lactate dehydrogenase - LDH.
Muscle damage will be measured by blood samples.
Measured: The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
Levels of interleukin 1 beta - IL-1b.
Inflammation will be measured by blood samples.
Measured: The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
Levels of interleukin 6 - IL-6.
Inflammation will be measured by blood samples.
Measured: The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
Levels of tumor necrosis factor alpha - TNF-a.
Inflammation will be measured by blood samples.
Measured: The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
Levels of Thiobarbituric acid - TBARS
Oxidative stress will be measured by blood samples.
Measured: The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
Levels of carbonylated proteins.
Oxidative stress will be measured by blood samples.
Measured: The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
Activity of catalase - CAT.
Oxidative stress will be measured by blood samples.
Measured: The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
Activity of superoxidedismutase - SOD.
Oxidative stress will be measured by blood samples.
Measured: The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
Time until exhaustion.
The time until exhaustion will be measured by the software of ergospirometry system.
Measured: Immediately after (1 minute) of ergospirometry test (progressive running test). Observation: the time until exhaustion will be measured during the progressive running test.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start16 Jan 2019
- Primary completion16 Feb 2019
- Study completion16 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle; Fatigue, HeartStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Ernesto Cesar Pinto Leal Junior, University of Nove de Julho
- Investigators
- Ernesto Cesar Leal Junior, PhD, Principal investigator, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03803956
- Sponsor's protocol ID
- 397774/2011
- Status last verified
- Jul 2019
- First submitted
- 9 Jan 2019
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31827687
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03803956
- Acronym / sponsor ID
- 397774/2011
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 16 Jan 2019 (actual)
- Primary completion
- 16 Feb 2019 (actual)
- Study completion
- 16 Feb 2019 (actual)
- First posted
- 15 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active PBMT | Active comparator | Device: Active PBMTApplication of PBMT (Photobiomodulation Therapy) with a total dose of 850 Joules. |
| Placebo PBMT | Placebo comparator | Device: Placebo PBMTApplication of placebo PBMT (Photobiomodulation Therapy) without any dose (0 Joule). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active PBMTThe 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. | Device | Active PBMT |
| Placebo PBMTThe 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. | Device | Placebo PBMT |
Primary outcome
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.
12 secondary outcomes
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.
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.
Activity of creatine kinase - CK.
Time frame: The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
Activity of lactate dehydrogenase - LDH.
Time frame: The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
Levels of interleukin 1 beta - IL-1b.
Time frame: The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
Levels of interleukin 6 - IL-6.
Time frame: The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
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).
Levels of Thiobarbituric acid - TBARS
Time frame: The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
Levels of carbonylated proteins.
Time frame: The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
Activity of catalase - CAT.
Time frame: The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
Activity of superoxidedismutase - SOD.
Time frame: The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
- Derived from this study: PubMed 31827687Tomazoni 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ernesto Cesar Leal Junior, PhD principal investigator
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active PBMT in people with Muscle; Fatigue, Heart and Skeletal Muscle Recovery, run by University of Nove de Julho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03803956, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2019; AzTrials last refreshed its copy on 28 Oct 2026.