- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06252467
Photobiomodulation Therapy on Performance in Successive Cycling Tests
Effects of Photobiomodulation Therapy on Performance in Successive Time-to-Exhaustion Cycling Tests: A Randomized Double-Blinded Placebo Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Rio Grande Do Sul
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Porto Alegre, Rio Grande Do Sul, Brazil, 90690200
- Marco Aurelio Vaz
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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. |
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.
|
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
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
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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.
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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.
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Secondary Outcome Measures
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.
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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).
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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.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 708.362
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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