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Trial record 66 of 10364 for:    strength

Effects of Photobiomodulation Therapy in Strength Training and Detraining in Humans

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ClinicalTrials.gov Identifier: NCT03858179
Recruitment Status : Recruiting
First Posted : February 28, 2019
Last Update Posted : August 15, 2019
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Ernesto Cesar Pinto Leal Junior, University of Nove de Julho

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.

Condition or disease Intervention/treatment Phase
Muscle Strength Device: PBMT Device: Placebo Not Applicable

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:

  1. PBMT before the strength training sessions and PBMT during the detraining period;
  2. PBMT before the strength training sessions and placebo during the detraining period;
  3. Placebo before the strength training sessions and PBMT during the detraining period;
  4. 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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).
Primary Purpose: Prevention
Official Title: Effects of Photobiomodulation Therapy in Strength Training and Detraining in Humans
Actual Study Start Date : March 25, 2019
Estimated Primary Completion Date : December 5, 2019
Estimated Study Completion Date : December 5, 2019

Arm Intervention/treatment
Experimental: PBMT + training/ PBMT + detraining
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 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.

Experimental: PBMT + training/ placebo + detraining
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: PBMT
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.

Device: Placebo
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.

Experimental: Placebo + training/ PBMT + detraining
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: PBMT
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.

Device: Placebo
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.

Placebo Comparator: Placebo + training/ placebo + detraining
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
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Peak Torque [ Time Frame: 4, 8, and 12 weeks after starting the training period. ]
    The peak torque will be measured by Maximum Voluntary Contraction (MVC) test.

  2. 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 strength will be measured by one-repetition maximum (1-RM) test.

  3. 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 thickness will be measured by ultrasound imaging.

  4. 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 fascicle length will be measured by ultrasound imaging.

  5. 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). ]
    Muscle fiber pennation angle will be measured by ultrasound imaging.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03858179


Contacts
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Contact: Ernesto Cesar Pinto Leal Junior, PhD +55 11 33859134 ernesto.leal.junior@gmail.com

Locations
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Brazil
Laboratory of Phototherapy and Innovative Technologies in Health Recruiting
São Paulo, Brazil, 01504-001
Contact: Ernesto Cesar Pinto Leal Junior, PhD    +55 11 33859134      
Sponsors and Collaborators
University of Nove de Julho
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
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Principal Investigator: Ernesto Cesar Pinto Leal Junior, PhD University of Nove de Julho

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Responsible Party: Ernesto Cesar Pinto Leal Junior, Full professor, University of Nove de Julho
ClinicalTrials.gov Identifier: NCT03858179     History of Changes
Other Study ID Numbers: 1781602
First Posted: February 28, 2019    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared upon request addressed to the principal investigator.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ernesto Cesar Pinto Leal Junior, University of Nove de Julho:
Photobiomodulation Therapy
Low-level Laser Therapy
Skeletal Muscle Strenght
Strength Training