NCT03420391

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 5, 2018

Completed
1.3 years until next milestone

Study Start

First participant enrolled

May 20, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 19, 2019

Completed
Last Updated

April 28, 2020

Status Verified

April 1, 2020

Enrollment Period

2 months

First QC Date

January 20, 2018

Last Update Submit

April 27, 2020

Conditions

Keywords

phototherapyperformancemuscular recoveryphotobiomodulation therapytime-window

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Delayed onset muscle soreness (DOMS)

    1 minute, 1 hour, 24 and 48 hours after the end of exercise protocol.

  • Biochemical marker of muscle damage

    1 minute, 1 hour, 24 and 48 hours after the end of exercise protocol.

Study Arms (6)

Placebo PBMT

PLACEBO COMPARATOR

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)

5 Minutes

ACTIVE COMPARATOR

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)

3 Hours

ACTIVE COMPARATOR

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)

6 Hours

ACTIVE COMPARATOR

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)

24 hours

ACTIVE COMPARATOR

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)

Control

NO INTERVENTION

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.

Interventions

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

24 hours3 Hours5 Minutes6 HoursPlacebo PBMT

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Nove de Julho

São Paulo, 01504-001, Brazil

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full professor

Study Record Dates

First Submitted

January 20, 2018

First Posted

February 5, 2018

Study Start

May 20, 2019

Primary Completion

July 19, 2019

Study Completion

July 19, 2019

Last Updated

April 28, 2020

Record last verified: 2020-04

Locations