PBMT on Muscular Performance and Recovery in Different Time-points

NCT ID: NCT03420391

Last Updated: 2020-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-20
• Study Completion Date: 2019-07-19

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.

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.

Conditions

Phototherapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Photobiomodulation Therapy (PBMT)

Intervention Type: DEVICE

Phototherapy device - Multi Radiance Medical® (Solon, OH, EUA)

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.

Group Type: ACTIVE_COMPARATOR

Photobiomodulation Therapy (PBMT)

Intervention Type: DEVICE

Phototherapy device - Multi Radiance Medical® (Solon, OH, EUA)

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.

Group Type: ACTIVE_COMPARATOR

Photobiomodulation Therapy (PBMT)

Intervention Type: DEVICE

Phototherapy device - Multi Radiance Medical® (Solon, OH, EUA)

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.

Group Type: ACTIVE_COMPARATOR

Photobiomodulation Therapy (PBMT)

Intervention Type: DEVICE

Phototherapy device - Multi Radiance Medical® (Solon, OH, EUA)

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.

Group Type: ACTIVE_COMPARATOR

Photobiomodulation Therapy (PBMT)

Intervention Type: DEVICE

Phototherapy device - Multi Radiance Medical® (Solon, OH, EUA)

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Photobiomodulation Therapy (PBMT)

Phototherapy device - Multi Radiance Medical® (Solon, OH, EUA)

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

University of Bergen

OTHER

Sponsor Role: collaborator

University of Nove de Julho

OTHER

Sponsor Role: lead

Responsible Party

Ernesto Cesar Pinto Leal Junior

Full professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidade Nove de Julho

São Paulo, , Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 33088573 (View on PubMed)

Other Identifiers

113553

Identifier Type: -

Identifier Source: org_study_id