PhototherapyNCT03695458
Local and Systemic Effects of Photobiomodulation Therapy on Muscle Performance and Recovery Post-exercise.
A study testing Phototherapy in people with Phototherapy and Low-level Laser Therapy, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
Recent studies with photobiomodulation therapy have shown positive results in delaying skeletal muscle fatigue and improving performance through levels of biochemical markers and variables related to exercise when this therapy was applied before exercise. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Phototherapy, Low-level Laser Therapy, Systemic
- What is being tested?
- Phototherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 14 Jan 2019to 14 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy individuals,
- Non-athletes
- Those who practice physical activity at maximal of once a week
- Between 18 and 35 years old,
- Male
- No history of musculoskeletal injury in the hip or knee previous two months of the study.
- Not be taking pharmacological agents and / or nutritional supplements, and should have frequency of 100% in all days of data collection.
Who cannot join
- Individuals who present musculoskeletal injury during the study
- Chronic joint disease in the non-dominant lower limb
Trial locations and contacts
1 site in 1 country.
About this study
Recent studies with photobiomodulation therapy have shown positive results in delaying skeletal muscle fatigue and improving performance through levels of biochemical markers and variables related to exercise when this therapy was applied before exercise. Some studies suggest that photobiomodulation therapy has systemic effects, but it is not known whether therapy exerts any systemic effects on human skeletal muscle. With this factor in mind, this research aims to verify the local and systemic effects of phototherapy on muscle performance and recovery after exercise in healthy male participants. This research consists in a randomized, triple-blinded, placebo-controlled trial, with participation of 30 healthy subjects. Will be analyzed parameters related to exercise performance (peak torque in the maximum voluntary contraction test- MVC), delayed onset muscle soreness (DOMS) by visual analogue scale (VAS), and biochemical marker of muscle damage (CK) and blood Lactate (BL). The analysis will be performed before exercise protocol (baseline), after 1 minute of the exercise, and 1, 24, 48 and 72 hours after the end of exercise protocol
Read the detailed description
A total of 30 healthy male non-athletes, between 18-35 years, will be randomly divided into 3 experimental groups, named "Placebo (Control)", "Local", "Systemic", according to the lower limb who will receive photobiomodulation therapy. Firstly, a blood collection will be performed by a nurse with sterile and disposable materials for posterior analysis of creatine kinase (CK) and Blood Lactate (BL). Delayed onset muscle soreness (DOMS) will be assessed with the Visual Analogue Scale (VAS) using a 10 cm line. Participants will be instructed to mark the line where their pain best fits at that time (0=no pain, 10=worst pain).Then, the maximum voluntary contraction test (MVC) will be performed, which will consist in performing 3 times of 5-sec isometric contractions of the non-dominant knee extensors in the isokinetic dynamometer device. During the execution of the MVC, the participants will be verbally encouraged to exert the greatest force at that moment. Photobiomodulation therapy will be applied 2 minutes after the MVC test in six points of non-dominant anterior thigh muscle. After irradiation, participants will perform the protocol of eccentric contractions. This protocol will be performed to induce muscle fatigue by resisting the movement of knee flexion in 5 series of 15 repetitions with 30 seconds -intervals (eccentric contractions). Assessments (blood collection, VAS and MVC) will be performed before warm-up (baseline), 1 minute after exercise protocol and 1, 24, 48 and 72 hours after eccentric exercise protocol.
- Conditions
- Phototherapy, Low-level Laser Therapy, Systemic
- Being tested
- Phototherapy
- Keywords
- phototherapy, systemic effect, recovery, performance, photobiomodulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhototherapyDevice
Also called Photobiomodulation Therapy, Low-Level Laser Therapy
The Photobiomodulation Therapy will be applied 3 minutes after MVC test in 6 points of the quadriceps muscle (2 points in vastus lateralis, 2 in rectus femoris and 2 in vastus medialis).
| Study group | Role | What they receive |
|---|---|---|
| Placebo-Control | Placebo comparator | Photobiomodulation Therapy with the placebo program will be applied in both legs. Receives: Device: Phototherapy |
| irradiation effect Local | Active comparator | Photobiomodulation Therapy with the active irradiation will be applied on the exercised leg and Photobiomodulation Therapy with the placebo program will be applied on the non-exercised leg. Receives: Device: Phototherapy |
| irradiation effect Systemic | Active comparator | Photobiomodulation Therapy with the active program will be applied on non-exercised leg and Photobiomodulation Therapy with the placebo program will be applied on the exercised leg. Receives: Device: Phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Voluntary Contraction
An isokinetic dynamometer (System 4, Biodex®, USA) will be used to assess muscle function and also for exercise protocol. Immediately after warm-up, volunteers will perform the maximum voluntary contraction test (MVC). Volunteers will be placed on the isokinetic dynamometer seated with a 100° angle between trunk and hip, and the non-dominant leg will be positioned to 60° knee flexion (0° corresponds to the total knee extension) and attached to the seat of the dynamometer through a belt. Volunteers will also be attached to the dynamometer seat through two straps on their trunk. MVC test consists of three isometric contractions of non-dominant lower limb knee extensors with a duration of 5 seconds and 30-second intervals between contractions, the highest torque value obtained at the three contractions (peak torque) will be used for statistical analysis.
Measured: baseline
Maximum Voluntary Contraction
An isokinetic dynamometer (System 4, Biodex®, USA) will be used to assess muscle function and also for exercise protocol. Immediately after warm-up, volunteers will perform the maximum voluntary contraction test (MVC). Volunteers will be placed on the isokinetic dynamometer seated with a 100° angle between trunk and hip, and the non-dominant leg will be positioned to 60° knee flexion (0° corresponds to the total knee extension) and attached to the seat of the dynamometer through a belt. Volunteers will also be attached to the dynamometer seat through two straps on their trunk. MVC test consists of three isometric contractions of non-dominant lower limb knee extensors with a duration of 5 seconds and 30-second intervals between contractions, the highest torque value obtained at the three contractions (peak torque) will be used for statistical analysis.
Measured: 1 minute after the protocol of eccentric contractions
Maximum Voluntary Contraction
An isokinetic dynamometer (System 4, Biodex®, USA) will be used to assess muscle function and also for exercise protocol. Immediately after warm-up, volunteers will perform the maximum voluntary contraction test (MVC). Volunteers will be placed on the isokinetic dynamometer seated with a 100° angle between trunk and hip, and the non-dominant leg will be positioned to 60° knee flexion (0° corresponds to the total knee extension) and attached to the seat of the dynamometer through a belt. Volunteers will also be attached to the dynamometer seat through two straps on their trunk. MVC test consists of three isometric contractions of non-dominant lower limb knee extensors with a duration of 5 seconds and 30-second intervals between contractions, the highest torque value obtained at the three contractions (peak torque) will be used for statistical analysis.
Measured: 1 hour after the protocol of eccentric contractions
Maximum Voluntary Contraction
An isokinetic dynamometer (System 4, Biodex®, USA) will be used to assess muscle function and also for exercise protocol. Immediately after warm-up, volunteers will perform the maximum voluntary contraction test (MVC). Volunteers will be placed on the isokinetic dynamometer seated with a 100° angle between trunk and hip, and the non-dominant leg will be positioned to 60° knee flexion (0° corresponds to the total knee extension) and attached to the seat of the dynamometer through a belt. Volunteers will also be attached to the dynamometer seat through two straps on their trunk. MVC test consists of three isometric contractions of non-dominant lower limb knee extensors with a duration of 5 seconds and 30-second intervals between contractions, the highest torque value obtained at the three contractions (peak torque) will be used for statistical analysis.
Measured: 24 hours after the protocol of eccentric contractions
Maximum Voluntary Contraction
An isokinetic dynamometer (System 4, Biodex®, USA) will be used to assess muscle function and also for exercise protocol. Immediately after warm-up, volunteers will perform the maximum voluntary contraction test (MVC). Volunteers will be placed on the isokinetic dynamometer seated with a 100° angle between trunk and hip, and the non-dominant leg will be positioned to 60° knee flexion (0° corresponds to the total knee extension) and attached to the seat of the dynamometer through a belt. Volunteers will also be attached to the dynamometer seat through two straps on their trunk. MVC test consists of three isometric contractions of non-dominant lower limb knee extensors with a duration of 5 seconds and 30-second intervals between contractions, the highest torque value obtained at the three contractions (peak torque) will be used for statistical analysis.
Measured: 48 hours after the protocol of eccentric contractions
Maximum Voluntary Contraction
An isokinetic dynamometer (System 4, Biodex®, USA) will be used to assess muscle function and also for exercise protocol. Immediately after warm-up, volunteers will perform the maximum voluntary contraction test (MVC). Volunteers will be placed on the isokinetic dynamometer seated with a 100° angle between trunk and hip, and the non-dominant leg will be positioned to 60° knee flexion (0° corresponds to the total knee extension) and attached to the seat of the dynamometer through a belt. Volunteers will also be attached to the dynamometer seat through two straps on their trunk. MVC test consists of three isometric contractions of non-dominant lower limb knee extensors with a duration of 5 seconds and 30-second intervals between contractions, the highest torque value obtained at the three contractions (peak torque) will be used for statistical analysis.
Measured: 72 hours after the protocol of eccentric contractions
Secondary outcomes (18)
enzymatic activity of creatine kinase (CK)
wil be analysis of the enzymatic activity of CK as an indirect marker of muscle damage, the initial absorbance will be read through the spectrophotometry test, use of specific reagent kits commercial manufactured (Labtest®, São Paulo - Brazil). 5 ml Blood samples, via antecubital vein puncture, will be collected in tubes by a nurse. The samples, it will be centrifuged at 3000 rpm for 20 minutes. The supernatant (serum) will then be pipetted and stored in tubes (Eppendorf ®) at -80°C for further analysis of the enzymatic activity of creatine kinase (CK).
Measured: baseline
enzymatic activity of creatine kinase (CK)
wil be analysis of the enzymatic activity of CK as an indirect marker of muscle damage, the initial absorbance will be read through the spectrophotometry test, use of specific reagent kits commercial manufactured (Labtest®, São Paulo - Brazil). 5 ml Blood samples, via antecubital vein puncture, will be collected in tubes by a nurse. The samples, it will be centrifuged at 3000 rpm for 20 minutes. The supernatant (serum) will then be pipetted and stored in tubes (Eppendorf ®) at -80°C for further analysis of the enzymatic activity of creatine kinase (CK).
Measured: 1 minute after the protocol of eccentric contractions
enzymatic activity of creatine kinase (CK)
wil be analysis of the enzymatic activity of CK as an indirect marker of muscle damage, the initial absorbance will be read through the spectrophotometry test, use of specific reagent kits commercial manufactured (Labtest®, São Paulo - Brazil). 5 ml Blood samples, via antecubital vein puncture, will be collected in tubes by a nurse. The samples, it will be centrifuged at 3000 rpm for 20 minutes. The supernatant (serum) will then be pipetted and stored in tubes (Eppendorf ®) at -80°C for further analysis of the enzymatic activity of creatine kinase (CK).
Measured: 1 hour after the protocol of eccentric contractions
enzymatic activity of creatine kinase (CK)
wil be analysis of the enzymatic activity of CK as an indirect marker of muscle damage, the initial absorbance will be read through the spectrophotometry test, use of specific reagent kits commercial manufactured (Labtest®, São Paulo - Brazil). 5 ml Blood samples, via antecubital vein puncture, will be collected in tubes by a nurse. The samples, it will be centrifuged at 3000 rpm for 20 minutes. The supernatant (serum) will then be pipetted and stored in tubes (Eppendorf ®) at -80°C for further analysis of the enzymatic activity of creatine kinase (CK).
Measured: 24 hours after the protocol of eccentric contractions
enzymatic activity of creatine kinase (CK)
wil be analysis of the enzymatic activity of CK as an indirect marker of muscle damage, the initial absorbance will be read through the spectrophotometry test, use of specific reagent kits commercial manufactured (Labtest®, São Paulo - Brazil). 5 ml Blood samples, via antecubital vein puncture, will be collected in tubes by a nurse. The samples, it will be centrifuged at 3000 rpm for 20 minutes. The supernatant (serum) will then be pipetted and stored in tubes (Eppendorf ®) at -80°C for further analysis of the enzymatic activity of creatine kinase (CK).
Measured: 48 hours after the protocol of eccentric contractions
enzymatic activity of creatine kinase (CK)
wil be analysis of the enzymatic activity of CK as an indirect marker of muscle damage, the initial absorbance will be read through the spectrophotometry test, use of specific reagent kits commercial manufactured (Labtest®, São Paulo - Brazil). 5 ml Blood samples, via antecubital vein puncture, will be collected in tubes by a nurse. The samples, it will be centrifuged at 3000 rpm for 20 minutes. The supernatant (serum) will then be pipetted and stored in tubes (Eppendorf ®) at -80°C for further analysis of the enzymatic activity of creatine kinase (CK).
Measured: 72 hours after the protocol of eccentric contractions
Blood Lactate
For analysis of the amount of blood lactate as an indirect marker of fatigue, a drop of blood will be collected from the first finger on the Bm-lactate strip and read through the Accutrend Plus COBAS® Monitor.
Measured: baseline
Blood Lactate
For analysis of the amount of blood lactate as an indirect marker of fatigue, a drop of blood will be collected from the first finger on the Bm-lactate strip and read through the Accutrend Plus COBAS® Monitor.
Measured: 1 minute after the protocol of eccentric contractions
Blood Lactate
For analysis of the amount of blood lactate as an indirect marker of fatigue, a drop of blood will be collected from the first finger on the Bm-lactate strip and read through the Accutrend Plus COBAS® Monitor.
Measured: 1 hour after the protocol of eccentric contractions
Blood Lactate
For analysis of the amount of blood lactate as an indirect marker of fatigue, a drop of blood will be collected from the first finger on the Bm-lactate strip and read through the Accutrend Plus COBAS® Monitor.
Measured: 24 hours after the protocol of eccentric contractions
Blood Lactate
For analysis of the amount of blood lactate as an indirect marker of fatigue, a drop of blood will be collected from the first finger on the Bm-lactate strip and read through the Accutrend Plus COBAS® Monitor.
Measured: 48 hours after the protocol of eccentric contractions
Blood Lactate
For analysis of the amount of blood lactate as an indirect marker of fatigue, a drop of blood will be collected from the first finger on the Bm-lactate strip and read through the Accutrend Plus COBAS® Monitor.
Measured: 72 hours after the protocol of eccentric contractions
Delayed onset muscle soreness (DOMS)
Delayed onset muscle soreness (DOMS) in the lower limb will be assessed using the Visual Analogue Pain Scale (VAS) using a 10 cm line, starting with the number 0, corresponding to no pain, and 10, corresponding to the worst possible pain. Volunteers will be instructed to mark the line where their pain best fits at that time. The evaluations will be performed prior to stretching and warm-up, 1 minute after the eccentric contractions protocol, and also 1, 24, 48, 72 hours after the protocol execution.
Measured: baseline
Delayed onset muscle soreness (DOMS)
Delayed onset muscle soreness (DOMS) in the lower limb will be assessed using the Visual Analogue Pain Scale (VAS) using a 10 cm line, starting with the number 0, corresponding to no pain, and 10, corresponding to the worst possible pain. Volunteers will be instructed to mark the line where their pain best fits at that time. The evaluations will be performed prior to stretching and warm-up, 1 minute after the eccentric contractions protocol, and also 1, 24, 48, 72 hours after the protocol execution.
Measured: 1 minute after the protocol of eccentric contractions
Delayed onset muscle soreness (DOMS)
Delayed onset muscle soreness (DOMS) in the lower limb will be assessed using the Visual Analogue Pain Scale (VAS) using a 10 cm line, starting with the number 0, corresponding to no pain, and 10, corresponding to the worst possible pain. Volunteers will be instructed to mark the line where their pain best fits at that time. The evaluations will be performed prior to stretching and warm-up, 1 minute after the eccentric contractions protocol, and also 1, 24, 48, 72 hours after the protocol execution.
Measured: 1 hour after the protocol of eccentric contractions
Delayed onset muscle soreness (DOMS)
Delayed onset muscle soreness (DOMS) in the lower limb will be assessed using the Visual Analogue Pain Scale (VAS) using a 10 cm line, starting with the number 0, corresponding to no pain, and 10, corresponding to the worst possible pain. Volunteers will be instructed to mark the line where their pain best fits at that time. The evaluations will be performed prior to stretching and warm-up, 1 minute after the eccentric contractions protocol, and also 1, 24, 48, 72 hours after the protocol execution.
Measured: 24 hours after the protocol of eccentric contractions
Delayed onset muscle soreness (DOMS)
Delayed onset muscle soreness (DOMS) in the lower limb will be assessed using the Visual Analogue Pain Scale (VAS) using a 10 cm line, starting with the number 0, corresponding to no pain, and 10, corresponding to the worst possible pain. Volunteers will be instructed to mark the line where their pain best fits at that time. The evaluations will be performed prior to stretching and warm-up, 1 minute after the eccentric contractions protocol, and also 1, 24, 48, 72 hours after the protocol execution.
Measured: 48 hours after the protocol of eccentric contractions
Delayed onset muscle soreness (DOMS)
Delayed onset muscle soreness (DOMS) in the lower limb will be assessed using the Visual Analogue Pain Scale (VAS) using a 10 cm line, starting with the number 0, corresponding to no pain, and 10, corresponding to the worst possible pain. Volunteers will be instructed to mark the line where their pain best fits at that time. The evaluations will be performed prior to stretching and warm-up, 1 minute after the eccentric contractions protocol, and also 1, 24, 48, 72 hours after the protocol execution.
Measured: 72 hours after the protocol of eccentric contractions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start14 Jan 2019
- Primary completion14 Apr 2019
- Study completion14 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PhototherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, triple-blind and placebo-controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Ernesto Cesar Pinto Leal Junior, University of Nove de Julho
- Investigators
- Caroline M Machado, 1, Principal investigator, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03695458
- Sponsor's protocol ID
- 617150400
- Status last verified
- Nov 2019
- First submitted
- 14 Sep 2018
- Last updated
- 2 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vanin AA, Miranda EF, Machado CS, de Paiva PR, Albuquerque-Pontes GM, Casalechi HL, de Tarso Camillo de Carvalho P, Leal-Junior EC. What is the best moment to apply phototherapy when associated to a strength training program? A randomized, double-blinded, placebo-controlled trial : Phototherapy in association to strength training. Lasers Med Sci. 2016 Nov;31(8):1555-1564. doi: 10.1007/s10103-016-2015-7. Epub 2016 Jul 1.
PubMed 27371449Miranda EF, Vanin AA, Tomazoni SS, Grandinetti Vdos S, de Paiva PR, Machado Cdos S, Monteiro KK, Casalechi HL, de Tarso P, de Carvalho C, Leal-Junior EC. Using Pre-Exercise Photobiomodulation Therapy Combining Super-Pulsed Lasers and Light-Emitting Diodes to Improve Performance in Progressive Cardiopulmonary Exercise Tests. J Athl Train. 2016 Feb;51(2):129-35. doi: 10.4085/1062-6050-51.3.10. Epub 2016 Mar 4.
PubMed 26942660Antonialli FC, De Marchi T, Tomazoni SS, Vanin AA, dos Santos Grandinetti V, de Paiva PR, Pinto HD, Miranda EF, de Tarso Camillo de Carvalho P, Leal-Junior EC. Phototherapy in skeletal muscle performance and recovery after exercise: effect of combination of super-pulsed laser and light-emitting diodes. Lasers Med Sci. 2014 Nov;29(6):1967-76. doi: 10.1007/s10103-014-1611-7. Epub 2014 Jun 19.
PubMed 24942380Machado CDSM, Casalechi HL, Vanin AA, de Azevedo JB, de Carvalho PTC, Leal-Junior ECP. Does photobiomodulation therapy combined to static magnetic field (PBMT-sMF) promote ergogenic effects even when the exercised muscle group is not irradiated? A randomized, triple-blind, placebo-controlled trial. BMC Sports Sci Med Rehabil. 2020 Aug 26;12:49. doi: 10.1186/s13102-020-00197-6. eCollection 2020.
PubMed 32864144
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local and Systemic Effects of Photobiomodulation Therapy on Muscle Performance and Recovery Post-exercise.
- ClinicalTrials.gov ID
- NCT03695458
- Acronym / sponsor ID
- 617150400
- Conditions
- Phototherapy, Low-level Laser Therapy, Systemic
- Keywords
- phototherapy, systemic effect, recovery, performance, photobiomodulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 14 Apr 2019 (actual)
- Study completion
- 14 May 2019 (actual)
- First posted
- 4 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recent studies with photobiomodulation therapy have shown positive results in delaying skeletal muscle fatigue and improving performance through levels of biochemical markers and variables related to exercise when this therapy was applied before exercise. Some studies suggest that photobiomodulation therapy has systemic effects, but it is not known whether therapy exerts any systemic effects on human skeletal muscle. With this factor in mind, this research aims to verify the local and systemic effects of phototherapy on muscle performance and recovery after exercise in healthy male participants. This research consists in a randomized, triple-blinded, placebo-controlled trial, with participation of 30 healthy subjects. Will be analyzed parameters related to exercise performance (peak torque in the maximum voluntary contraction test- MVC), delayed onset muscle soreness (DOMS) by visual analogue scale (VAS), and biochemical marker of muscle damage (CK) and blood Lactate (BL). The analysis will be performed before exercise protocol (baseline), after 1 minute of the exercise, and 1, 24, 48 and 72 hours after the end of exercise protocol
Detailed description
A total of 30 healthy male non-athletes, between 18-35 years, will be randomly divided into 3 experimental groups, named "Placebo (Control)", "Local", "Systemic", according to the lower limb who will receive photobiomodulation therapy. Firstly, a blood collection will be performed by a nurse with sterile and disposable materials for posterior analysis of creatine kinase (CK) and Blood Lactate (BL). Delayed onset muscle soreness (DOMS) will be assessed with the Visual Analogue Scale (VAS) using a 10 cm line. Participants will be instructed to mark the line where their pain best fits at that time (0=no pain, 10=worst pain).Then, the maximum voluntary contraction test (MVC) will be performed, which will consist in performing 3 times of 5-sec isometric contractions of the non-dominant knee extensors in the isokinetic dynamometer device. During the execution of the MVC, the participants will be verbally encouraged to exert the greatest force at that moment. Photobiomodulation therapy will be applied 2 minutes after the MVC test in six points of non-dominant anterior thigh muscle. After irradiation, participants will perform the protocol of eccentric contractions. This protocol will be performed to induce muscle fatigue by resisting the movement of knee flexion in 5 series of 15 repetitions with 30 seconds -intervals (eccentric contractions). Assessments (blood collection, VAS and MVC) will be performed before warm-up (baseline), 1 minute after exercise protocol and 1, 24, 48 and 72 hours after eccentric exercise protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized, triple-blind and placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| Placebo-Control | Placebo comparator | Device: PhototherapyPhotobiomodulation Therapy with the placebo program will be applied in both legs. |
| irradiation effect Local | Active comparator | Device: PhototherapyPhotobiomodulation Therapy with the active irradiation will be applied on the exercised leg and Photobiomodulation Therapy with the placebo program will be applied on the non-exercised leg. |
| irradiation effect Systemic | Active comparator | Device: PhototherapyPhotobiomodulation Therapy with the active program will be applied on non-exercised leg and Photobiomodulation Therapy with the placebo program will be applied on the exercised leg. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy individuals,
- Non-athletes
- Those who practice physical activity at maximal of once a week
- Between 18 and 35 years old,
- Male
Key exclusion criteria (2 listed)
- Individuals who present musculoskeletal injury during the study
- Chronic joint disease in the non-dominant lower limb
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhototherapyAlso: Photobiomodulation Therapy, Low-Level Laser TherapyThe Photobiomodulation Therapy will be applied 3 minutes after MVC test in 6 points of the quadriceps muscle (2 points in vastus lateralis, 2 in rectus femoris and 2 in vastus medialis). | Device | Placebo-Control, irradiation effect Local, irradiation effect Systemic |
Primary outcome
Maximum Voluntary Contraction
Time frame: baseline
An isokinetic dynamometer (System 4, Biodex®, USA) will be used to assess muscle function and also for exercise protocol. Immediately after warm-up, volunteers will perform the maximum voluntary contraction test (MVC). Volunteers will be placed on the isokinetic dynamometer seated with a 100° angle between trunk and hip, and the non-dominant leg will be positioned to 60° knee flexion (0° corresponds to the total knee extension) and attached to the seat of the dynamometer through a belt. Volunteers will also be attached to the dynamometer seat through two straps on their trunk. MVC test consists of three isometric contractions of non-dominant lower limb knee extensors with a duration of 5 seconds and 30-second intervals between contractions, the highest torque value obtained at the three contractions (peak torque) will be used for statistical analysis.
Maximum Voluntary Contraction
Time frame: 1 minute after the protocol of eccentric contractions
An isokinetic dynamometer (System 4, Biodex®, USA) will be used to assess muscle function and also for exercise protocol. Immediately after warm-up, volunteers will perform the maximum voluntary contraction test (MVC). Volunteers will be placed on the isokinetic dynamometer seated with a 100° angle between trunk and hip, and the non-dominant leg will be positioned to 60° knee flexion (0° corresponds to the total knee extension) and attached to the seat of the dynamometer through a belt. Volunteers will also be attached to the dynamometer seat through two straps on their trunk. MVC test consists of three isometric contractions of non-dominant lower limb knee extensors with a duration of 5 seconds and 30-second intervals between contractions, the highest torque value obtained at the three contractions (peak torque) will be used for statistical analysis.
Maximum Voluntary Contraction
Time frame: 1 hour after the protocol of eccentric contractions
An isokinetic dynamometer (System 4, Biodex®, USA) will be used to assess muscle function and also for exercise protocol. Immediately after warm-up, volunteers will perform the maximum voluntary contraction test (MVC). Volunteers will be placed on the isokinetic dynamometer seated with a 100° angle between trunk and hip, and the non-dominant leg will be positioned to 60° knee flexion (0° corresponds to the total knee extension) and attached to the seat of the dynamometer through a belt. Volunteers will also be attached to the dynamometer seat through two straps on their trunk. MVC test consists of three isometric contractions of non-dominant lower limb knee extensors with a duration of 5 seconds and 30-second intervals between contractions, the highest torque value obtained at the three contractions (peak torque) will be used for statistical analysis.
Maximum Voluntary Contraction
Time frame: 24 hours after the protocol of eccentric contractions
An isokinetic dynamometer (System 4, Biodex®, USA) will be used to assess muscle function and also for exercise protocol. Immediately after warm-up, volunteers will perform the maximum voluntary contraction test (MVC). Volunteers will be placed on the isokinetic dynamometer seated with a 100° angle between trunk and hip, and the non-dominant leg will be positioned to 60° knee flexion (0° corresponds to the total knee extension) and attached to the seat of the dynamometer through a belt. Volunteers will also be attached to the dynamometer seat through two straps on their trunk. MVC test consists of three isometric contractions of non-dominant lower limb knee extensors with a duration of 5 seconds and 30-second intervals between contractions, the highest torque value obtained at the three contractions (peak torque) will be used for statistical analysis.
Maximum Voluntary Contraction
Time frame: 48 hours after the protocol of eccentric contractions
An isokinetic dynamometer (System 4, Biodex®, USA) will be used to assess muscle function and also for exercise protocol. Immediately after warm-up, volunteers will perform the maximum voluntary contraction test (MVC). Volunteers will be placed on the isokinetic dynamometer seated with a 100° angle between trunk and hip, and the non-dominant leg will be positioned to 60° knee flexion (0° corresponds to the total knee extension) and attached to the seat of the dynamometer through a belt. Volunteers will also be attached to the dynamometer seat through two straps on their trunk. MVC test consists of three isometric contractions of non-dominant lower limb knee extensors with a duration of 5 seconds and 30-second intervals between contractions, the highest torque value obtained at the three contractions (peak torque) will be used for statistical analysis.
Maximum Voluntary Contraction
Time frame: 72 hours after the protocol of eccentric contractions
An isokinetic dynamometer (System 4, Biodex®, USA) will be used to assess muscle function and also for exercise protocol. Immediately after warm-up, volunteers will perform the maximum voluntary contraction test (MVC). Volunteers will be placed on the isokinetic dynamometer seated with a 100° angle between trunk and hip, and the non-dominant leg will be positioned to 60° knee flexion (0° corresponds to the total knee extension) and attached to the seat of the dynamometer through a belt. Volunteers will also be attached to the dynamometer seat through two straps on their trunk. MVC test consists of three isometric contractions of non-dominant lower limb knee extensors with a duration of 5 seconds and 30-second intervals between contractions, the highest torque value obtained at the three contractions (peak torque) will be used for statistical analysis.
18 secondary outcomes
enzymatic activity of creatine kinase (CK)
Time frame: baseline
enzymatic activity of creatine kinase (CK)
Time frame: 1 minute after the protocol of eccentric contractions
enzymatic activity of creatine kinase (CK)
Time frame: 1 hour after the protocol of eccentric contractions
enzymatic activity of creatine kinase (CK)
Time frame: 24 hours after the protocol of eccentric contractions
enzymatic activity of creatine kinase (CK)
Time frame: 48 hours after the protocol of eccentric contractions
enzymatic activity of creatine kinase (CK)
Time frame: 72 hours after the protocol of eccentric contractions
Blood Lactate
Time frame: baseline
Blood Lactate
Time frame: 1 minute after the protocol of eccentric contractions
Blood Lactate
Time frame: 1 hour after the protocol of eccentric contractions
Blood Lactate
Time frame: 24 hours after the protocol of eccentric contractions
Blood Lactate
Time frame: 48 hours after the protocol of eccentric contractions
Blood Lactate
Time frame: 72 hours after the protocol of eccentric contractions
Delayed onset muscle soreness (DOMS)
Time frame: baseline
Delayed onset muscle soreness (DOMS)
Time frame: 1 minute after the protocol of eccentric contractions
Delayed onset muscle soreness (DOMS)
Time frame: 1 hour after the protocol of eccentric contractions
Delayed onset muscle soreness (DOMS)
Time frame: 24 hours after the protocol of eccentric contractions
Delayed onset muscle soreness (DOMS)
Time frame: 48 hours after the protocol of eccentric contractions
Delayed onset muscle soreness (DOMS)
Time frame: 72 hours after the protocol of eccentric contractions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2019.
- Background: PubMed 27371449Vanin AA, Miranda EF, Machado CS, de Paiva PR, Albuquerque-Pontes GM, Casalechi HL, de Tarso Camillo de Carvalho P, Leal-Junior EC. What is the best moment to apply phototherapy when associated to a strength training program? A randomized, double-blinded, placebo-controlled trial : Phototherapy in association to strength training. Lasers Med Sci. 2016 Nov;31(8):1555-1564. doi: 10.1007/s10103-016-2015-7. Epub 2016 Jul 1.
- Background: PubMed 26942660Miranda EF, Vanin AA, Tomazoni SS, Grandinetti Vdos S, de Paiva PR, Machado Cdos S, Monteiro KK, Casalechi HL, de Tarso P, de Carvalho C, Leal-Junior EC. Using Pre-Exercise Photobiomodulation Therapy Combining Super-Pulsed Lasers and Light-Emitting Diodes to Improve Performance in Progressive Cardiopulmonary Exercise Tests. J Athl Train. 2016 Feb;51(2):129-35. doi: 10.4085/1062-6050-51.3.10. Epub 2016 Mar 4.
- Background: PubMed 24942380Antonialli FC, De Marchi T, Tomazoni SS, Vanin AA, dos Santos Grandinetti V, de Paiva PR, Pinto HD, Miranda EF, de Tarso Camillo de Carvalho P, Leal-Junior EC. Phototherapy in skeletal muscle performance and recovery after exercise: effect of combination of super-pulsed laser and light-emitting diodes. Lasers Med Sci. 2014 Nov;29(6):1967-76. doi: 10.1007/s10103-014-1611-7. Epub 2014 Jun 19.
- Derived from this study: PubMed 32864144Machado CDSM, Casalechi HL, Vanin AA, de Azevedo JB, de Carvalho PTC, Leal-Junior ECP. Does photobiomodulation therapy combined to static magnetic field (PBMT-sMF) promote ergogenic effects even when the exercised muscle group is not irradiated? A randomized, triple-blind, placebo-controlled trial. BMC Sports Sci Med Rehabil. 2020 Aug 26;12:49. doi: 10.1186/s13102-020-00197-6. eCollection 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline M Machado, 1 principal investigator
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phototherapy in people with Phototherapy and Low-level Laser Therapy, run by University of Nove de Julho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Voluntary Contraction (time frame: baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03695458, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2019.