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PBMT on Muscular Performance and Recovery in Different Time-points

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ClinicalTrials.gov Identifier: NCT03420391
Recruitment Status : Completed
First Posted : February 5, 2018
Last Update Posted : April 28, 2020
Sponsor:
Collaborators:
Fundação de Amparo à Pesquisa do Estado de São Paulo
University of Bergen
Information provided by (Responsible Party):
Ernesto Cesar Pinto Leal Junior, University of Nove de Julho

Brief Summary:
Recent studies with photobiomodulation therapy (PBMT) have shown positive results delaying skeletal muscle fatigue and improving the status of biochemical markers related to skeletal muscle damage when these therapies were applied before exercise. The aim of this project is to verify the effects of PBMT in improvement of skeletal muscle performance and skeletal muscle recovery in healthy male subjects. This project aim also to validate the concept that simultaneous use of three wavelengths and light sources lead to optimized action independently of time-window between irradiation and the exercise.

Condition or disease Intervention/treatment Phase
Phototherapy Device: Photobiomodulation Therapy (PBMT) Not Applicable

Detailed Description:
This is a randomized, triple-blinded, placebo-controlled trial. Sixty healthy untrained male subjects will be randomly allocated to six experimental groups: Placebo, Control, PBMT 5 mins, PBMT 3h, PBMT 6h and PBMT 24 hours. PBMT will be applied precisely two minutes after baseline MVC test. Then, after five minutes, 3, 6 hours or 1 day (24 hours) of PBMT the eccentric exercise protocol will be performed. We will analyze maximum voluntary contraction (MVC), creatine kinase (CK) activity and delayed onset muscle soreness (DOMS). Assessments will be performed at baseline, immediately after (1 minute), 1 hour, 24 and 48 hours after the eccentric exercise protocol.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Sixty participants will be enrolled in the study. Participants will be randomized in six groups:

Control: Participants will receive no intervention; Placebo: Participants will receive placebo PBMT; 5 minutes: Participants will perform the eccentric exercise protocol 5 minutes after PBMT.

3 hours: Participants will perform the eccentric exercise protocol 3 hours after PBMT.

6 hours: Participants will perform the eccentric exercise protocol 6 hours after PBMT.

24 hours: Participants will perform the eccentric exercise protocol 24 hours after PBMT.

Assessments will be performed at baseline, after 1 minute, 1 hour, 24 and 48 hours after the end of exercise protocol.

Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Photobiomodulation Therapy (PBMT) on Muscular Performance and Recovery in Different Time-points
Actual Study Start Date : May 20, 2019
Actual Primary Completion Date : July 19, 2019
Actual Study Completion Date : July 19, 2019

Arm Intervention/treatment
Placebo Comparator: Placebo PBMT
Participants will be treated with placebo PBMT in different time-points before the eccentric exercise protocol (5 minutes, 3 hours, 6 hours or 24 hours). Assessments will be performed at baseline, 1 minute, 1 hour, 24 and 48 hours after the end of exercise protocol.
Device: Photobiomodulation Therapy (PBMT)
Phototherapy device - Multi Radiance Medical® (Solon, OH, EUA)

Active Comparator: 5 Minutes

Participants will be performed the eccentric exercise protocol 5 minutes after PBMT.

Assessments will be performed at baseline, 1 minute, 1 hour, 24 and 48 hours after the end of exercise protocol.

Device: Photobiomodulation Therapy (PBMT)
Phototherapy device - Multi Radiance Medical® (Solon, OH, EUA)

Active Comparator: 3 Hours

3 hours: Participants will be performed the eccentric exercise protocol 3 hours after PBMT.

Assessments will be performed before at baseline, 1 minute, 1 hour and 24, 48 hours after the end of exercise protocol.

Device: Photobiomodulation Therapy (PBMT)
Phototherapy device - Multi Radiance Medical® (Solon, OH, EUA)

Active Comparator: 6 Hours

6 hours: Participants will be performed the eccentric exercise protocol 6 hours after PBMT.

Assessments will be performed at baseline, 1 minute, 1 hour, 24 and 48 hours after the end of exercise protocol.

Device: Photobiomodulation Therapy (PBMT)
Phototherapy device - Multi Radiance Medical® (Solon, OH, EUA)

Active Comparator: 24 hours
24 hours: Participants will be performed the eccentric exercise protocol 24 hours after PBMT. Assessments will be performed before at baseline, 1 minute, 1 hour, 24 and 48 hours after the end of exercise protocol.
Device: Photobiomodulation Therapy (PBMT)
Phototherapy device - Multi Radiance Medical® (Solon, OH, EUA)

No Intervention: Control
Participants will not receive intervention. Assessments will be performed at baseline, 1 minute, 1 hour, 24 and 48 hours after the end of exercise protocol.



Primary Outcome Measures :
  1. Torque peak / maximum voluntary contraction - MVC [ Time Frame: 1 minute, 1 hour, 24 and 48 hours after the end of exercise protocol. ]
    Assessment was performed in the isokinetic dynamometer (System 4, Biodex®, USA)


Secondary Outcome Measures :
  1. Delayed onset muscle soreness (DOMS) [ Time Frame: 1 minute, 1 hour, 24 and 48 hours after the end of exercise protocol. ]
    Assessment was performed through visual analogue scale (VAS). A visual analogue scale (VAS) of 100 mm was used as a self-rating of volunteers DOMS intensity, with assistance of a blinded researcher, where "0" corresponds to no pain and 100mm corresponds to the worst pain possible.

  2. Biochemical marker of muscle damage [ Time Frame: 1 minute, 1 hour, 24 and 48 hours after the end of exercise protocol. ]
    Analysis of Creatine Kinase (CK) levels



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

Inclusion Criteria:

  • Healthy
  • not athletes or who engage in physical activity at most once a week
  • Individuals should not present a history of musculoskeletal injury in the hip and knee regions in the two months prior to the studies
  • they should not be using pharmacological agents and / or nutritional supplements
  • They must attend 100% of the data collections.

Exclusion Criteria:

  • Individuals who do not meet the criteria mentioned above or who present musculoskeletal damage during collection were excluded from the study.

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): NCT03420391


Locations
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Brazil
Universidade Nove de Julho
São Paulo, Brazil, 01504-001
Sponsors and Collaborators
University of Nove de Julho
Fundação de Amparo à Pesquisa do Estado de São Paulo
University of Bergen
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ernesto Cesar Pinto Leal Junior, Full professor, University of Nove de Julho
ClinicalTrials.gov Identifier: NCT03420391    
Other Study ID Numbers: 113553
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020

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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:
phototherapy
performance
muscular recovery
photobiomodulation therapy
time-window