Effects of Photobiomodulation Therapy in Aerobic Training and Detraining in Humans

NCT03879226 | Completed

• 1 other identifier: 1781602-2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

In last years it has been demonstrated that photobiomodulation therapy (PBMT) has ergogenic effects. However some key aspects, such as the potentially beneficial effects of PBMT during the detraining period still remain unknown. Therefore, the aim of this project is to evaluate the effects of PBMT applied before and after aerobic training sessions and during the detraining period.

Conditions

Aerobic Endurance

Keywords

Photobiomodulation Therapy; Low-level Laser Therapy; Aerobic Endurance

Outcome Measures

Primary Outcomes (1)

• Time until exhaustion.

  The time until exhaustion will be measured by the software of ergospirometry system.

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

Secondary Outcomes (3)

• Time until exhaustion.

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

• Maximum oxygen consumption (VO2).

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

• Fat percentage.

  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 and after the aerobic training sessions (12 weeks, 3 times a week) and PBMT applied during the detraining period (4 weeks, 3 times a week).

Device: PBMT

PBMT + training/ placebo + detraining

EXPERIMENTAL

PBMT applied before and after the aerobic training sessions (12 weeks, 3 times a week) and placebo applied during the detraining period (4 weeks, 3 times a week).

Device: PBMT; Device: Placebo

Placebo + training/ PBMT + detraining

EXPERIMENTAL

Placebo applied before and after the aerobic training sessions (12 weeks, 3 times a week) and PBMT applied during the detraining period (4 weeks, 3 times a week).

Device: PBMT; Device: Placebo

Placebo + training/ placebo + detraining

PLACEBO COMPARATOR

Placebo applied before and after the aerobic training sessions (12 weeks, 3 times a week) and placebo applied during the detraining period (4 weeks, 3 times a week).

Device: Placebo

Interventions

PBMT DEVICE

PBMT will be applied bilaterally using the direct contact method with light pressure on the skin at different sites, namely 9 sites on the knee extensor muscles, 6 sites on the knee flexor muscles, and 2 sites on the plantar flexor muscles. 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 the applications during the training and/or detraining periods will be 30 Joules (J) per site (510 J per lower limb). PBMT will be applied before and after each training session and during the detraining period, depending on the group to which the volunteers are allocated.

PBMT + training/ PBMT + detraining; PBMT + training/ placebo + detraining; Placebo + training/ PBMT + detraining

Placebo DEVICE

Placebo will be applied bilaterally using the direct contact method with light pressure on the skin at different sites, namely 9 sites on the knee extensor muscles, 6 sites on the knee flexor muscles, and 2 sites on the plantar flexor muscles. 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 will be applied before and after each training session and during the detraining period, depending on the group to which the volunteers are allocated.

PBMT + training/ placebo + detraining; Placebo + training/ PBMT + detraining; Placebo + training/ placebo + detraining

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (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.

Sponsors & Collaborators

• University of Nove de Julho: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

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, Casalechi HL, Tomazoni SS, Machado CDSM, Ribeiro NF, Pereira AL, de Oliveira MFD, Alves MNDS, Dos Santos MC, Takara IET, Miranda EF, de Carvalho PTC, Leal-Junior ECP. Does the combination of photobiomodulation therapy (PBMT) and static magnetic fields (sMF) potentiate the effects of aerobic endurance training and decrease the loss of performance during detraining? A randomised, triple-blinded, placebo-controlled trial. BMC Sports Sci Med Rehabil. 2020 Apr 10;12:23. doi: 10.1186/s13102-020-00171-2. eCollection 2020.

  PMID: 32308987 DERIVED

• de Paiva PRV, Casalechi HL, Tomazoni SS, Machado CDSM, Miranda EF, Ribeiro NF, Pereira AL, da Costa AS, Dias LB, Souza BCG, Aguiar Lino MM, de Carvalho PTC, Leal-Junior ECP. Effects of photobiomodulation therapy in aerobic endurance training and detraining in humans: Protocol for a randomized placebo-controlled trial. Medicine (Baltimore). 2019 May;98(18):e15317. doi: 10.1097/MD.0000000000015317.

  PMID: 31045769 DERIVED

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: March 15, 2019
• First Posted: March 18, 2019
• Study Start: March 25, 2019
• Primary Completion: August 25, 2019
• Study Completion: August 25, 2019
• Last Updated: September 3, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

BR (1)