Photobiomodulation Therapy on Performance in Successive Cycling Tests

February 7, 2024 updated by: Marco Aurélio Vaz, PhD

Effects of Photobiomodulation Therapy on Performance in Successive Time-to-Exhaustion Cycling Tests: A Randomized Double-Blinded Placebo Controlled Trial

The goal of this study was to investigate the effects of Photobiomodulation therapy (PBMT) on performance, oxygen uptake (VO2 kinetics), and lower limb muscle oxygenation during three successive time-to-exhaustion tests (TTEs) in cyclists. This was a double blind, randomized, crossover, placebo-controlled trial study. Sixteen cyclists (~23 years old), with a cycling training volume of ~460 km/week, volunteered for this study. In the first session, cyclists performed a maximal incremental test to determine maximal oxygen uptake and maximal power output (POMAX). In the following sessions, cyclists performed three consecutive TTEs at POMAX. Before each test, PBMT (135 J/thigh) or a placebo (PLA) PBMT was applied to both thighs. VO2 amplitude, O2 deficit, time delay, oxyhemoglobin (O2Hb), deoxyhemoglobin (HHb), and total hemoglobin (tHb) were measured during tests on the right vastus lateralis. The PBMT, applied before three successive TTE, increased performance of the first and second TTE (~10-12%) tests, speed of VO2 and HHb kinetics during the first test, and increased peripheral muscle oxygenation (increase in HHb and tHb) in the first and second exhaustion tests. However, the PBMT effects were attenuated in the third TTE, as performance and all the other outcomes were similar to the ones from the PLA intervention. In summary, PBMT application increased the first and second successive TTEs, speed of VO2, and muscle oxygenation.

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

The goal of this study was to investigate the effects of Photobiomodulation therapy (PBMT) on performance, oxygen uptake (VO2 kinetics), and lower limb muscle oxygenation during three successive time-to-exhaustion tests (TTEs) in cyclists. Our study was characterized as a crossover, randomized, double-blind trial (blinding of the cyclists and the researcher responsible for evaluations). All protocols were explained to the participants, who voluntarily provided their consent to participate in the investigation through an informed consent document. This study received approval from the Research Ethics Committee for Human Subjects Studies at the institution where the research was conducted (number 708.362). Inclusion criteria involved cyclists aged 18-30 years, with a competitive history and no history of musculoskeletal injuries in the lower limbs in the last two years. Exclusion criteria included chronic disease, smoking, metabolic disorders, use of steroids in the last six months, chronic disease, physical disabilities, and use of antibiotic drugs in the previous week. The cyclists participating in the present study had ~6.5 years of regular training/competition and no history of lower limb muscular and/or skeletal injuries. Each cyclist visited the laboratory on three occasions. At the first visit, cyclists performed a maximum incremental test and familiarization to three successive TTEs. At the two subsequent visits, participants performed a standard protocol of three successive TTEs at maximal power output (POMAX) with preferred cadence, and PBMT or placebo (PLA) treatments were applied before each trial. The three testing days were performed with a 72h interval apart. A single therapist was involved with the random allocation of the PBMT and PLA interventions. This therapist received instructions not to disclose the treatment modality employed during each assessment session to either the cyclists or other researchers involved with data collection and data analysis. Furthermore, cyclists utilized opaque eyewear to shield their eyes and obstruct their visual access (visual blinding) during the PBMT or PLA intervention. The therapist was explicitly advised against revealing the treatment modality to both the cyclists and the other researchers. PBMT did not elicit any thermal or tactile sensations, thereby ensuring that athletes remained unaware of the specific application on their thigh area. The random assignment was determined through a basic drawing of lots during the first testing session, determining the allocation of either active PBMT or inactive PLA.

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.
16

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
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90690200
        • Marco Aurelio Vaz

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Cyclists aged 18-30 years;
  • Competitive history;
  • No history of musculoskeletal injuries in the lower limbs in the last two years.

Exclusion Criteria:

  • Chronic disease;
  • Smoking;
  • Metabolic disorders;
  • Use of steroids in the last six months;
  • Physical disabilities;
  • Use of antibiotic drugs in the previous week.

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: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

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.
Active Comparator: Active Comparator

Device: Active Photobiomodulation Therapy Phototherapy treatment (Photobiomodulation therapy or placebo) was performed using a Photobiomodulation therapy device (Vectra Genisys Systems, Chattanooga Group, Dallas, TX, USA). The cluster probe consisted of five low-level laser therapy diodes (850 nm) and 28 light emitting diodes therapy (670 nm, 880 nm, and 950 nm). Photobiomodulation therapy was applied in nine sites of each quadriceps femoris muscle

. A dosage of 15 J per site led to a total energy of 135 J per thigh, effectively increasing cycling performance in a previous study. We chose to apply Photobiomodulation therapy specifically to the quadriceps femoris because this muscle group is of utmost significance in generating torque and propelling the pedaling cycle. Its pivotal role in cycling performance made this muscle a prime target for the Photobiomodulation therapy intervention in our study.
Device: Photobiomodulation Therapy

Phototherapy treatment (Photobiomodulation therapy or placebo) was performed using a Photobiomodulation therapy device (Vectra Genisys Systems, Chattanooga Group, Dallas, TX, USA). The cluster probe consisted of five low-level laser therapy diodes (850 nm) and 28 light emitting diodes therapy (670 nm, 880 nm, and 950 nm). Photobiomodulation therapy was applied in nine sites of each quadriceps femoris muscle

. A dosage of 15 J per site led to a total energy of 135 J per thigh, effectively increasing cycling performance in a previous study. We chose to apply Photobiomodulation therapy specifically to the quadriceps femoris because this muscle group is of utmost significance in generating torque and propelling the pedaling cycle. Its pivotal role in cycling performance made this muscle a prime target for the Photobiomodulation therapy intervention in our study.
Placebo Comparator: Placebo Comparator
Device: Placebo Photobiomodulation The placebo treatment was performed in exactly the same manner as the Photobiomodulation therapy treatment, but with the device switched off, and the cluster was held stationary in contact with the skin at a 90° angle, with light pressure on the skin. The total application time of Photobiomodulation therapy or placebo was ~5 min for both limbs (9 points per thigh = 18 points × 16 s per point) before each time-to-exhaustion test.
Device: Placebo Photobiomodulation
The placebo treatment was performed in exactly the same manner as the Photobiomodulation therapy treatment, but with the device switched off, and the cluster was held stationary in contact with the skin at a 90° angle, with light pressure on the skin. The total application time of Photobiomodulation therapy or placebo was ~5 min for both limbs (9 points per thigh = 18 points × 16 s per point) before each time-to-exhaustion test.

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
Cycling performance
Time Frame: Cyclits performed a standard protocol of three successive tests to exhaustion at maximal power output with preferred cadence, and photobiomodulation therapy or placebo treatments were applied before each trial. The three testing days were performed
Cyclists performed the three successive time-to-exhaustion at maximal power output at their preferred cadence. Exhaustion was defined as the time when the cyclist was unable to maintain a cadence above 70 rotations per minute. During the successive time-to-exhaustion, cadence and power output were measured using the cycle ergometer software (Excalibur Sport, Lode Medical Technology, Groningen, Groninga, The Netherlands). The cyclists' evaluation was conducted utilizing a cycle ergometer (Excalibur Sport, Lode Medical Technology, Groningen, Groninga, The Netherlands) configured to match their bike's handlebar and seat settings.
Cyclits performed a standard protocol of three successive tests to exhaustion at maximal power output with preferred cadence, and photobiomodulation therapy or placebo treatments were applied before each trial. The three testing days were performed
Oxygen uptake
Time Frame: Oxygen uptake response was measured during the three sucessive time-to-exhaustion in two days (Photobiomodulation Therapy or Placebo) with a 72 hours interval apart.
Oxygen uptake was measured breath-by-breath using an open-circuit gas analyzer (Quark CPET, Cosmed, Rome, Lazio, Italy). Oxygen uptake measurements were plotted to facilitate the exclusion of values lying beyond four standard deviations above or below the average of the dynamic window (three breaths), taken as the reference for the overall curve average. Analysis of oxygen uptake kinetics during successive time-to-exhaustion was converted into 5 seconds windows, and mean values were calculated. The analysis of oxygen uptake kinetics was dependent on the duration of the three time-to-exhaustion for each athlete in each condition (Photobiomodulation therapy or placebo). Oxygen uptake kinetics were calculated with the nonlinear least-squares method implemented in MATLAB (Mathworks, Natick, MA, USA) to adjust the oxygen uptake data.
Oxygen uptake response was measured during the three sucessive time-to-exhaustion in two days (Photobiomodulation Therapy or Placebo) with a 72 hours interval apart.

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
Periphery muscle oxygenation
Time Frame: Periphery muscle oxygenation response was measured during the three sucessive time-to-exhaustion in two days (Photobiomodulation Therapy or Placebo) with a 72 hours interval apart.
Peripheral muscle oxygenation data collection was performed using a NIRS (PortaMon, Artinis Medical Systems, Elst, Guéldria, Netherlands) probe (light emitting and photoreceptor), which was positioned in the vastus lateralis muscle belly of the right lower limb, longitudinally located between the femur's lateral epicondyle and trochanter, fixed with adhesive tape (3M Company, Saint Paul, MN, USA), and wrapped by the cyclist's bretelle to prevent light penetration during all time-to-exhaustion. Data from the NIRS system were analyzed from average windows every 20% of the time-to-exhaustion tests and retests. The oxyhemoglobin, deoxyhemoglobin, and total hemoglobin were evaluated. Furthermore, oxyhemoglobin, deoxyhemoglobin, and total hemoglobin values were normalized by their respective mean values obtained at rest before the first time-to-exhaustion in each condition, which were used to compare the experimental situations (Phobiomodulation Therapy or Placebo).
Periphery muscle oxygenation response was measured during the three sucessive time-to-exhaustion in two days (Photobiomodulation Therapy or Placebo) with a 72 hours interval apart.

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.
Marco Aurélio Vaz, PhD

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.
July 14, 2014

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.
May 23, 2023

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.
October 11, 2023

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).
November 14, 2023

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.
February 7, 2024

First Posted (Estimated)

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 9, 2024

Study Record Updates

Last Update Posted (Estimated)

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.
February 9, 2024

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.
February 7, 2024

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.
February 1, 2024

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.
  • 708.362

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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