PBMT on Muscular Performance and Recovery in Different Time-points

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Phototherapy

Intervention / Treatment
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* Device: Photobiomodulation Therapy (PBMT)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo PBMT<br>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)<br>* Phototherapy device - Multi Radiance Medical® (Solon, OH, EUA)<br>|
| Active Comparator: 5 Minutes<br>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)<br>* Phototherapy device - Multi Radiance Medical® (Solon, OH, EUA)<br>|
| Active Comparator: 3 Hours<br>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)<br>* Phototherapy device - Multi Radiance Medical® (Solon, OH, EUA)<br>|
| Active Comparator: 6 Hours<br>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)<br>* Phototherapy device - Multi Radiance Medical® (Solon, OH, EUA)<br>|
| Active Comparator: 24 hours<br>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)<br>* Phototherapy device - Multi Radiance Medical® (Solon, OH, EUA)<br>|
| No Intervention: Control<br>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?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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phototherapy, performance, muscular recovery, photobiomodulation therapy, time-window