PBMT on Muscular Performance and Recovery in Different Time-points

April 27, 2020 updated by: Ernesto Cesar Pinto Leal Junior, University of Nove de Julho

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
1 minute, 1 hour, 24 and 48 hours after the end of exercise protocol.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
1 minute, 1 hour, 24 and 48 hours after the end of exercise protocol.
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
1 minute, 1 hour, 24 and 48 hours after the end of exercise protocol.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Nove de Julho

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Bergen
Fundação de Amparo à Pesquisa do Estado de São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 20, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 19, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 19, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 20, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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