PBMT on Muscular Performance and Recovery in Different Time-points

Effects of Photobiomodulation Therapy (PBMT) on Muscular Performance and Recovery in Different Time-points

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.

Study Overview

• Status: Completed
• Conditions: Phototherapy
• Intervention / Treatment: Device: Photobiomodulation Therapy (PBMT)

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 01504-001
    • Universidade Nove de Julho

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

6

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delayed onset muscle soreness (DOMS)	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.	1 minute, 1 hour, 24 and 48 hours after the end of exercise protocol.
Biochemical marker of muscle damage	Analysis of Creatine Kinase (CK) levels	1 minute, 1 hour, 24 and 48 hours after the end of exercise protocol.

Collaborators and Investigators

• Sponsor: University of Nove de Julho
• Collaborators: University of Bergen; Fundação de Amparo à Pesquisa do Estado de São Paulo

Publications and helpful links

General Publications

• Leal-Junior ECP, de Oliveira MFD, Joensen J, Stausholm MB, Bjordal JM, Tomazoni SS. What is the optimal time-response window for the use of photobiomodulation therapy combined with static magnetic field (PBMT-sMF) for the improvement of exercise performance and recovery, and for how long the effects last? A randomized, triple-blinded, placebo-controlled trial. BMC Sports Sci Med Rehabil. 2020 Oct 19;12:64. doi: 10.1186/s13102-020-00214-8. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2019
• Primary Completion (Actual): July 19, 2019
• Study Completion (Actual): July 19, 2019

Study Registration Dates

• First Submitted: January 20, 2018
• First Submitted That Met QC Criteria: January 27, 2018
• First Posted (Actual): February 5, 2018

Study Record Updates

• Last Update Posted (Actual): April 28, 2020
• Last Update Submitted That Met QC Criteria: April 27, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: phototherapy; performance; muscular recovery; photobiomodulation therapy; time-window
• Other Study ID Numbers: 113553

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No