NCT03858179

Brief 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. Therefore, the aim of this project is to evaluate the ergogenic effects of PBMT in detraining after a strength training protocol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 28, 2019

Completed
25 days until next milestone

Study Start

First participant enrolled

March 25, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 13, 2022

Completed
Last Updated

June 27, 2025

Status Verified

June 1, 2025

Enrollment Period

3.1 years

First QC Date

February 26, 2019

Last Update Submit

June 23, 2025

Conditions

Keywords

Photobiomodulation TherapyLow-level Laser TherapySkeletal Muscle StrenghtStrength Training

Outcome Measures

Primary Outcomes (1)

  • Peak Torque

    The peak torque will be measured by Maximum Voluntary Contraction (MVC) test.

    16 weeks - 4 weeks after completing the training (detraining period).

Secondary Outcomes (5)

  • Peak Torque

    4, 8, and 12 weeks after starting the training period.

  • Muscle strength

    4, 8, and 12 weeks after starting the training period, and at 4 weeks after completing the training (detraining period).

  • Muscle thickness

    4, 8, and 12 weeks after starting the training period, and at 4 weeks after completing the training (detraining period).

  • Muscle fascicle length

    4, 8, and 12 weeks after starting the training period, and at 4 weeks after completing the training (detraining period).

  • Muscle fiber pennation angle

    4, 8, and 12 weeks after starting the training period, and at 4 weeks after completing the training (detraining period).

Study Arms (4)

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).

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).

Device: PBMTDevice: 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).

Device: PBMTDevice: 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).

Device: Placebo

Interventions

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.

PBMT + training/ PBMT + detrainingPBMT + training/ placebo + detrainingPlacebo + training/ PBMT + detraining
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.

PBMT + training/ placebo + detrainingPlacebo + training/ PBMT + detrainingPlacebo + training/ placebo + detraining

Eligibility Criteria

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

You may qualify if:

  • Healthy men;
  • Aged from 18 to 35 years;
  • Complete at least 80% of the study procedures will be included in the study.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory of Phototherapy and Innovative Technologies in Health

São Paulo, São Paulo, 01504-001, Brazil

Location

Related Publications (2)

  • 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.

  • de 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.

Study Officials

  • Ernesto Cesar Pinto Leal Junior, PhD

    University of Nove de Julho

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
A researcher will program the device (placebo or PMBT) and will be instructed not to inform the volunteers or other researchers as to the type of treatment (PMBT or placebo). Therefore, the researcher responsible for the treatment will be blinded to the type of treatment being administered to the volunteers. 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 (placebo or PBMT).
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full professor

Study Record Dates

First Submitted

February 26, 2019

First Posted

February 28, 2019

Study Start

March 25, 2019

Primary Completion

May 13, 2022

Study Completion

May 13, 2022

Last Updated

June 27, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

Data will be shared upon request addressed to the principal investigator.

Shared Documents
STUDY PROTOCOL, SAP, CSR

Locations