Muscle StrengthNCT03858179
Effects of Photobiomodulation Therapy in Strength Training and Detraining in Humans
A study testing PBMT in people with Muscle Strength, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
In last years it has been demonstrated that photobiomodulation therapy (PBMT) has ergogenic effects, improving muscular performance and accelerating post-exercise recovery. However, many aspects related to these effects and its' clinical applicability remain unknown. 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 Strength
- What is being tested?
- PBMT
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 25 Mar 2019to 13 May 2022
- 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
- Healthy men;
- Aged from 18 to 35 years;
- Complete at least 80% of the study procedures will be included in the study.
Who cannot join
- History of musculoskeletal injury in the hip and knee regions in the 2 months before the study;
- Become injured during the study;
- Regularly use pharmacological agents and/ or nutritional supplements;
- Signs and symptoms of any neurological, metabolic, inflammatory, pulmonary, oncological, or cardiovascular disease that may limit the execution of high-intensity exercises.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Laboratory of Phototherapy and Innovative Technologies in Health
São Paulo, São Paulo, 01504-001
About this study
In last years it has been demonstrated that photobiomodulation therapy (PBMT) has ergogenic effects, improving muscular performance and accelerating post-exercise recovery. However, many aspects related to these effects and its' clinical applicability remain unknown. Therefore, the aim of this project is to evaluate the ergogenic effects of PBMT in detraining after a strength training protocol.
Read the detailed description
It will be carried out a randomized, triple-blind, placebo-controlled trial.
Forty-eight volunteers will be randomly allocated to four experimental groups:
- PBMT before the strength training sessions and PBMT during the detraining period;
- PBMT before the strength training sessions and placebo during the detraining period;
- Placebo before the strength training sessions and PBMT during the detraining period;
- Placebo before the strength training sessions and placebo during the detraining period .
The individuals randomly allocated to the different groups will be subjected to 12 consecutive weeks of dynamic strength training involving leg-press and knee extension exercises in leg-press and leg-extension machines, respectively, 2 times a week.After the 12-week training period, the volunteers will receive the application of PBMT or placebo depending on the group to which they are allocated for 4 weeks (2 times a week) without training.
The data will be collected by a blind assessor. It will be analyzed the muscular strength and the structural properties of quadriceps before starting the study (baseline), at 4, 8, and 12 weeks after starting the training period, and at 4 weeks after completing the training (detraining period), in both lower limbs.
The findings will be tested for their normality using the Shapiro-Wilk test. Parametric data will be expressed as mean and standard deviation and non-parametric data as median and respective upper and lower limits. Parametric data will be analyzed by two-way repeated measures analysis of variance (ANOVA; time versus experimental group) with post-hoc Bonferroni correction. Non-parametric data will be analyzed using the Friedman test and, secondarily, the Wilcoxon signed-rank test. Data will be analyzed in terms of both their absolute values and their relationship to the percentage change based on the values established in the baseline tests. The significance level will be set at p<0.05.
- Conditions
- Muscle Strength
- Being tested
- PBMT, Placebo
- Keywords
- Photobiomodulation Therapy, Low-level Laser Therapy, Skeletal Muscle Strenght, Strength Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBMTDevice
PBMT will be applied bilaterally using the direct contact method with light pressure on the skin to 6 sites of the anterior thigh (2 medial, 2 lateral, and 2 central). A 12-diode cluster, with 4 905-nm laser diodes (12.5W peak power for each diode), 4 875-nm LED diodes (17.5 mW mean power for each diode), and 4 640-nm LED diodes (15 mW mean power for each diode), manufactured by Multi Radiance Medical® (Solon, OH, USA), will be used to apply the PBMT. The dose used for applications during the training and/or detraining periods will be 30 Joules (J) per site (180 J per thigh). PBMT will be applied before each workout and during the detraining period, depending on the group to which the volunteers are allocated.
PlaceboDevice
Placebo PBMT will be applied bilaterally using the direct contact method with light pressure on the skin to 6 sites of the anterior thigh (2 medial, 2 lateral, and 2 central). The placebo PBMT will per performed using the dose of 0 J per diode. The sounds and signals emitted from the device as well as the information displayed on the screen will be identical, regardless of the type of treatment (active or placebo). Placebo PBMT will be applied before each workout and during the detraining period, depending on the group to which the volunteers are allocated.
| Study group | Role | What they receive |
|---|---|---|
| PBMT + training/ PBMT + detraining | Experimental | PBMT applied before the strength training sessions (12 weeks, 2 times a week) and PBMT applied during the detraining period (4 weeks, 2 times a week). Receives: Device: PBMT |
| PBMT + training/ placebo + detraining | Experimental | PBMT applied before the strength training sessions (12 weeks, 2 times a week) and placebo applied during the detraining period (4 weeks, 2 times a week). Receives: Device: PBMT; Device: Placebo |
| Placebo + training/ PBMT + detraining | Experimental | Placebo applied before the strength training sessions (12 weeks, 2 times a week) and PBMT applied during the detraining period (4 weeks, 2 times a week). Receives: Device: PBMT; Device: Placebo |
| Placebo + training/ placebo + detraining | Placebo comparator | Placebo applied before the strength training sessions (12 weeks, 2 times a week) and placebo applied during the detraining period (4 weeks, 2 times a week). Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Torque
The peak torque will be measured by Maximum Voluntary Contraction (MVC) test.
Measured: 16 weeks - 4 weeks after completing the training (detraining period).
Secondary outcomes (5)
Peak Torque
The peak torque will be measured by Maximum Voluntary Contraction (MVC) test.
Measured: 4, 8, and 12 weeks after starting the training period.
Muscle strength
Muscle strength will be measured by one-repetition maximum (1-RM) test.
Measured: 4, 8, and 12 weeks after starting the training period, and at 4 weeks after completing the training (detraining period).
Muscle thickness
Muscle thickness will be measured by ultrasound imaging.
Measured: 4, 8, and 12 weeks after starting the training period, and at 4 weeks after completing the training (detraining period).
Muscle fascicle length
Muscle fascicle length will be measured by ultrasound imaging.
Measured: 4, 8, and 12 weeks after starting the training period, and at 4 weeks after completing the training (detraining period).
Muscle fiber pennation angle
Muscle fiber pennation angle will be measured by ultrasound imaging.
Measured: 4, 8, and 12 weeks after starting the training period, and at 4 weeks after completing the training (detraining period).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2019
- Study start25 Mar 2019
- Primary completion13 May 2022
- Study completion13 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Muscle StrengthStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 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 Pinto Leal Junior, PhD, Principal investigator, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03858179
- Sponsor's protocol ID
- 1781602
- Status last verified
- Jun 2025
- First submitted
- 26 Feb 2019
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared upon request addressed to the principal investigator.
Publications
de Paiva PRV, Tomazoni SS, Machado CDSM, Pereira AL, Ribeiro NF, Lino MMA, Dias LB, de Oliveira MFD, de Araujo-Silva OM, Dorneles MP, Vanin AA, Baroni BM, Bjordal JM, Casalechi HL, Leal-Junior ECP. Effects of photobiomodulation therapy combined with static magnetic field on training adaptations and detraining responses: a randomised placebo-controlled trial. BMJ Open Sport Exerc Med. 2025 Dec 12;11(4):e002799. doi: 10.1136/bmjsem-2025-002799. eCollection 2025.
PubMed 41393334de Paiva PRV, Casalechi HL, Tomazoni SS, Machado CDSM, Vanin AA, Baroni BM, de Carvalho PTC, Leal-Junior ECP. Effects of photobiomodulation therapy combined to static magnetic field in strength training and detraining in humans: protocol for a randomised placebo-controlled trial. BMJ Open. 2019 Oct 28;9(10):e030194. doi: 10.1136/bmjopen-2019-030194.
PubMed 31662370
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Photobiomodulation Therapy in Strength Training and Detraining in Humans
- ClinicalTrials.gov ID
- NCT03858179
- Acronym / sponsor ID
- 1781602
- Conditions
- Muscle Strength
- Keywords
- Photobiomodulation Therapy, Low-level Laser Therapy, Skeletal Muscle Strenght, Strength Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 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
- 25 Mar 2019 (actual)
- Primary completion
- 13 May 2022 (actual)
- Study completion
- 13 May 2022 (actual)
- First posted
- 28 Feb 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.
In last years it has been demonstrated that photobiomodulation therapy (PBMT) has ergogenic effects, improving muscular performance and accelerating post-exercise recovery. However, many aspects related to these effects and its' clinical applicability remain unknown. Therefore, the aim of this project is to evaluate the ergogenic effects of PBMT in detraining after a strength training protocol.
Detailed description
It will be carried out a randomized, triple-blind, placebo-controlled trial.
Forty-eight volunteers will be randomly allocated to four experimental groups:
- PBMT before the strength training sessions and PBMT during the detraining period;
- PBMT before the strength training sessions and placebo during the detraining period;
- Placebo before the strength training sessions and PBMT during the detraining period;
- Placebo before the strength training sessions and placebo during the detraining period .
The individuals randomly allocated to the different groups will be subjected to 12 consecutive weeks of dynamic strength training involving leg-press and knee extension exercises in leg-press and leg-extension machines, respectively, 2 times a week.After the 12-week training period, the volunteers will receive the application of PBMT or placebo depending on the group to which they are allocated for 4 weeks (2 times a week) without training.
The data will be collected by a blind assessor. It will be analyzed the muscular strength and the structural properties of quadriceps before starting the study (baseline), at 4, 8, and 12 weeks after starting the training period, and at 4 weeks after completing the training (detraining period), in both lower limbs.
The findings will be tested for their normality using the Shapiro-Wilk test. Parametric data will be expressed as mean and standard deviation and non-parametric data as median and respective upper and lower limits. Parametric data will be analyzed by two-way repeated measures analysis of variance (ANOVA; time versus experimental group) with post-hoc Bonferroni correction. Non-parametric data will be analyzed using the Friedman test and, secondarily, the Wilcoxon signed-rank test. Data will be analyzed in terms of both their absolute values and their relationship to the percentage change based on the values established in the baseline tests. The significance level will be set at p<0.05.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PBMT + training/ PBMT + detraining | Experimental | Device: PBMTPBMT applied before the strength training sessions (12 weeks, 2 times a week) and PBMT applied during the detraining period (4 weeks, 2 times a week). |
| PBMT + training/ placebo + detraining | Experimental | Device: PBMT, Device: PlaceboPBMT applied before the strength training sessions (12 weeks, 2 times a week) and placebo applied during the detraining period (4 weeks, 2 times a week). |
| Placebo + training/ PBMT + detraining | Experimental | Device: PBMT, Device: PlaceboPlacebo applied before the strength training sessions (12 weeks, 2 times a week) and PBMT applied during the detraining period (4 weeks, 2 times a week). |
| Placebo + training/ placebo + detraining | Placebo comparator | Device: PlaceboPlacebo applied before the strength training sessions (12 weeks, 2 times a week) and placebo applied during the detraining period (4 weeks, 2 times a week). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy men;
- Aged from 18 to 35 years;
- Complete at least 80% of the study procedures will be included in the study.
Key exclusion criteria (4 listed)
- History of musculoskeletal injury in the hip and knee regions in the 2 months before the study;
- Become injured during the study;
- Regularly use pharmacological agents and/ or nutritional supplements;
- Signs and symptoms of any neurological, metabolic, inflammatory, pulmonary, oncological, or cardiovascular disease that may limit the execution of high-intensity exercises.
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 |
|---|---|---|
| PBMTPBMT will be applied bilaterally using the direct contact method with light pressure on the skin to 6 sites of the anterior thigh (2 medial, 2 lateral, and 2 central). A 12-diode cluster, with 4 905-nm laser diodes (12.5W peak power for each diode), 4 875-nm LED diodes (17.5 mW mean power for each diode), and 4 640-nm LED diodes (15 mW mean power for each diode), manufactured by Multi Radiance Medical® (Solon, OH, USA), will be used to apply the PBMT. The dose used for applications during the training and/or detraining periods will be 30 Joules (J) per site (180 J per thigh). PBMT will be applied before each workout and during the detraining period, depending on the group to which the volunteers are allocated. | Device | PBMT + training/ PBMT + detraining, PBMT + training/ placebo + detraining, Placebo + training/ PBMT + detraining |
| PlaceboPlacebo PBMT will be applied bilaterally using the direct contact method with light pressure on the skin to 6 sites of the anterior thigh (2 medial, 2 lateral, and 2 central). The placebo PBMT will per performed using the dose of 0 J per diode. The sounds and signals emitted from the device as well as the information displayed on the screen will be identical, regardless of the type of treatment (active or placebo). Placebo PBMT will be applied before each workout and during the detraining period, depending on the group to which the volunteers are allocated. | Device | PBMT + training/ placebo + detraining, Placebo + training/ PBMT + detraining, Placebo + training/ placebo + detraining |
Primary outcome
Peak Torque
Time frame: 16 weeks - 4 weeks after completing the training (detraining period).
The peak torque will be measured by Maximum Voluntary Contraction (MVC) test.
5 secondary outcomes
Peak Torque
Time frame: 4, 8, and 12 weeks after starting the training period.
Muscle strength
Time frame: 4, 8, and 12 weeks after starting the training period, and at 4 weeks after completing the training (detraining period).
Muscle thickness
Time frame: 4, 8, and 12 weeks after starting the training period, and at 4 weeks after completing the training (detraining period).
Muscle fascicle length
Time frame: 4, 8, and 12 weeks after starting the training period, and at 4 weeks after completing the training (detraining period).
Muscle fiber pennation angle
Time frame: 4, 8, and 12 weeks after starting the training period, and at 4 weeks after completing the training (detraining period).
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 27 Jun 2025.
- Derived from this study: PubMed 41393334de Paiva PRV, Tomazoni SS, Machado CDSM, Pereira AL, Ribeiro NF, Lino MMA, Dias LB, de Oliveira MFD, de Araujo-Silva OM, Dorneles MP, Vanin AA, Baroni BM, Bjordal JM, Casalechi HL, Leal-Junior ECP. Effects of photobiomodulation therapy combined with static magnetic field on training adaptations and detraining responses: a randomised placebo-controlled trial. BMJ Open Sport Exerc Med. 2025 Dec 12;11(4):e002799. doi: 10.1136/bmjsem-2025-002799. eCollection 2025.
- Derived from this study: PubMed 31662370de Paiva PRV, Casalechi HL, Tomazoni SS, Machado CDSM, Vanin AA, Baroni BM, de Carvalho PTC, Leal-Junior ECP. Effects of photobiomodulation therapy combined to static magnetic field in strength training and detraining in humans: protocol for a randomised placebo-controlled trial. BMJ Open. 2019 Oct 28;9(10):e030194. doi: 10.1136/bmjopen-2019-030194.
- Individual participant dataSharing planned: Yes. Data will be shared upon request addressed to the principal investigator.
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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 Pinto 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 PBMT in people with Muscle Strength, 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 3 inclusion and 4 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 27 Jun 2025. 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?
Peak Torque (time frame: 16 weeks - 4 weeks after completing the training (detraining period).). 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 NCT03858179, which also lists 2 linked publications.
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 27 Jun 2025; AzTrials last refreshed its copy on 8 Nov 2026.