Muscle StrengthNCT04349085
Effects of Photobiomodulation Therapy Combined With Static Magnetic Field in CrossFit® Athletes
A study testing Effective PBMT/sMF in people with Muscle Strength, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
Crossfit® is a method of strength training and fitness built on functional movements, constantly varied and executed at high intensity. Competitions such as the Crossfit® involve physically demanding activities, which in addition to being performed at high intensity also use great measures of aerobic capacity related… 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
- Muscle Strength
- What is being tested?
- Effective PBMT/sMF
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteBrazil
- Study dates
- 17 Apr 2020to 10 May 2020
- 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
- Crossfit® amateur male athletes;
- who did not present a history of musculoskeletal injury in the regions of the hips, knees and calves in the month preceding the study;
- who were not using pharmacological agents;
- athletes should have been practicing the sport for at least 1 year;
- voluntarily commit to participate in all stages.
Who cannot join
- who presented musculoskeletal or joint injuries during data collection.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Laboratory of Phototherapy and Innovative Technologies in Health
São Paulo, 01504-001
About this study
Official title: Effects of Photobiomodulation Therapy Combined With Static Magnetic Field Applied in Different Moments on Performance and Muscle Recovery in CrossFit® Athletes
Crossfit® is a method of strength training and fitness built on functional movements, constantly varied and executed at high intensity. Competitions such as the Crossfit® involve physically demanding activities, which in addition to being performed at high intensity also use great measures of aerobic capacity related with performance. These characteristics cause metabolic and muscular stress, as well as a decrease in physical performance. The demand for intensity is the cause of concern regarding the practice of Crossfit® and the risk of injuries. Studies using photobiomodulation therapy combined with static magnetic fields (PBMT/sMF) to delay fatigue and increase performance have obtained positive results in different types of exercise and application times. However, there are no studies investigating the effects of PBMT/sMF in training with similar characteristics as Crossfit®. Therefore, the aim of this project is to verify the effects of PBMT/sMF on performance and muscle recovery of Crossfit® athletes at different times of application (pre workout of the day [WOD] and/or post WOD) in order to determine the best way to use the therapy.
Read the detailed description
To achieve the proposed objective it will be performed a randomized, crossover, triple-blind (volunteers, outcome assessors and therapists), placebo-controlled trial.
Twelve volunteers will be allocated to four interventions/situation. The order of the interventions/situations will be randomized.
The volunteers will be treated by a blinded therapist.
The outcomes will be obtained at baseline (prior to WOD), and 1 hour, 24 and 48 hours after WOD. Except for the ratings of perceived exertion that will be obtained at baseline, after WOD, and 1 hour, 24 and 48 hours after WOD. In addition, for the functional analysis the data will be collected at baseline, after applied intervention, and 1 hour, 24 and 48 hours after WOD. The data will be collected by a blinded assessor.
The WOD will be consisted in finish as quickly as possible a sequence of three exercises (Calories in Assault AirBike®, Hang Squat Clean and Box Jump Over), in a well-known series model for the athletes, without rest.
The investigators will analyze: ratings of perceived exertion; activity of creatine kinase (CK); levels of the cytokine Interleukin-6 (IL-6), and maximum number of free squat reps in 1 minute.
Statistical analysis:
All data will be analyzed both in their absolute values and in relation to their percentage variation from the values obtained in the pre-WOD (baseline) assessments. The results obtained will be tested for normality using the Kolmogorov-Smirnov test. If data show normal distribution, the ANOVA test (one or two way depending on the outcome analyzed) with post-hoc Bonferroni will be used. The level of statistical significance will be p<0.05.
- Conditions
- Muscle Strength
- Being tested
- Effective PBMT/sMF, Placebo PBMT/sMF
- Keywords
- Photobiomodulation Therapy, Low-level Laser Therapy, Static Magnectic Fields, CrossFit®, Strength Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effective PBMT/sMFDevice
A cluster with 20 diodes, manufactured by Multi Radiance Medical® (Solon, OH, USA), will be used: 4 diodes of 905 nm (1.25 average power, 50 W of peak power for each diode), 8 diodes of 850 nm (40 mW of average power for each diode) and 4 diodes of 633 nm (25 mW average power for each diode). Effective PBMT/sMF will be applied in direct contact with the skin and light pressure in: 4 sites in the knee extensor/hip flexor muscles, 3 sites in the knee flexor/hip extensor muscles and 1 site in the plantar flexor muscles. The effective PBMT/sMF will be applied to both lower limbs. The dose used for applications will be approximately 270 J for knee extensors/hip flexors, 180 J for knee flexors/hip extensors, and 60 J for plantar flexors.
Placebo PBMT/sMFDevice
A cluster manufactured by Multi Radiance Medical® (Solon, OH, USA) with 20 diodes will be used: Placebo PBMT/sMF will be applied in direct contact with the skin and light pressure in: 4 sites in the knee extensor/hip flexor muscles, 3 sites in the knee flexor/hip extensor muscles and 1 site in the plantar flexor muscles. The placebo PBMT/sMF will be applied to both lower limbs. The dose used for applications will be approximately 0 J per diode. The sounds and signals emitted from the device as well as the information displayed on the screen will be identical, regardless of the type of treatment (active or placebo).
| Study group | Role | What they receive |
|---|---|---|
| Effective PBMT/sMF before WOD and Placebo PBMT/sMF after WOD | Experimental | PBMT/sMF will be applied in two steps: effective PBMT/sMF will be applied before the WOD and placebo PBMT/sMF will be applied after the WOD. Receives: Device: Effective PBMT/sMF; Device: Placebo PBMT/sMF |
| Placebo PBMT/sMF before WOD and Effective PBMT/sMF after WOD | Experimental | PBMT/sMF will be applied in two steps: placebo PBMT/sMF will be applied before the WOD and effective PBMT/sMF will be applied after the WOD. Receives: Device: Effective PBMT/sMF; Device: Placebo PBMT/sMF |
| Effective PBMT/sMF before WOD and Effective PBMT/sMF after WOD | Experimental | PBMT/sMF will be applied in two steps: effective PBMT/sMF will be applied before the WOD and effective PBMT/sMF will be applied after the WOD. Receives: Device: Effective PBMT/sMF |
| Placebo PBMT/sMF before WOD and Placebo PBMT/sMF after WOD. | Placebo comparator | PBMT/sMF will be applied in two steps: placebo PBMT/sMF will be applied before the WOD and placebo PBMT/sMF will be applied after the WOD. Receives: Device: Placebo PBMT/sMF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in functional capacity
The functional capacity will be measured by a maximum number of free squat repetitions within 1 minute.
Measured: 1 minute post-treatment, 1hour, 24 hours and 48 hours after WOD (workout of the day).
Secondary outcomes (3)
Perception of exercise intensity
The perception of exercise intensity will be measured by a 0-100 Ratings of Perceived Exertion Scale: in this scale lower score, means lower degree of fatigue and higher score, means higher degree of fatigue.
Measured: 1 minute after WOD, 1 minute post-treatment, 1 hour, 24 hours and 48 hours after WOD (workout of the day).
Activity of creatine kinase (CK)
The activity of CK will be analyzed by spectrophotometry and using specific reagent kits from the blood samples collected.
Measured: 1 hour, 24 hours and 48 hours after WOD (workout of the day).
Levels of interleukin-6 (IL-6)
The levels of interleukin-6 will be analyzed by enzyme-linked immunosorbent assay (ELISA) and using specific reagent kits from the blood samples collected.
Measured: 1 hour, 24 hours and 48 hours after WOD (workout of the day).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start17 Apr 2020
- Primary completion10 May 2020
- Study completion10 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle StrengthStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The volunteers will be allocated to four interventions/situation: 1. Effective PBMT/sMF before WOD and placebo PBMT/sMF after WOD; 2. Placebo PBMT/sMF before WOD and effective PBMT/sMF after WOD; 3. Effective PBMT/sMF before WOD and effective PBMT/sMF after WOD; 4. Placebo PBMT/sMF before WOD and placebo PBMT/sMF after WOD. The order of the interventions will be randomized.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ernesto Cesar Pinto Leal Junior, University of Nove de Julho
- Investigators
- Ernesto Cesar Pinto Leal Junior, PhD, Principal investigator, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04349085
- Sponsor's protocol ID
- 3.360.743
- Status last verified
- Jul 2020
- First submitted
- 10 Apr 2020
- Last updated
- 13 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data will be shared upon request addressed to the principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Photobiomodulation Therapy Combined With Static Magnetic Field Applied in Different Moments on Performance and Muscle Recovery in CrossFit® Athletes
- ClinicalTrials.gov ID
- NCT04349085
- Acronym / sponsor ID
- 3.360.743
- Conditions
- Muscle Strength
- Keywords
- Photobiomodulation Therapy, Low-level Laser Therapy, Static Magnectic Fields, CrossFit®, Strength Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 17 Apr 2020 (actual)
- Primary completion
- 10 May 2020 (actual)
- Study completion
- 10 May 2020 (actual)
- First posted
- 16 Apr 2020 (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.
Crossfit® is a method of strength training and fitness built on functional movements, constantly varied and executed at high intensity. Competitions such as the Crossfit® involve physically demanding activities, which in addition to being performed at high intensity also use great measures of aerobic capacity related with performance. These characteristics cause metabolic and muscular stress, as well as a decrease in physical performance. The demand for intensity is the cause of concern regarding the practice of Crossfit® and the risk of injuries. Studies using photobiomodulation therapy combined with static magnetic fields (PBMT/sMF) to delay fatigue and increase performance have obtained positive results in different types of exercise and application times. However, there are no studies investigating the effects of PBMT/sMF in training with similar characteristics as Crossfit®. Therefore, the aim of this project is to verify the effects of PBMT/sMF on performance and muscle recovery of Crossfit® athletes at different times of application (pre workout of the day [WOD] and/or post WOD) in order to determine the best way to use the therapy.
Detailed description
To achieve the proposed objective it will be performed a randomized, crossover, triple-blind (volunteers, outcome assessors and therapists), placebo-controlled trial.
Twelve volunteers will be allocated to four interventions/situation. The order of the interventions/situations will be randomized.
The volunteers will be treated by a blinded therapist.
The outcomes will be obtained at baseline (prior to WOD), and 1 hour, 24 and 48 hours after WOD. Except for the ratings of perceived exertion that will be obtained at baseline, after WOD, and 1 hour, 24 and 48 hours after WOD. In addition, for the functional analysis the data will be collected at baseline, after applied intervention, and 1 hour, 24 and 48 hours after WOD. The data will be collected by a blinded assessor.
The WOD will be consisted in finish as quickly as possible a sequence of three exercises (Calories in Assault AirBike®, Hang Squat Clean and Box Jump Over), in a well-known series model for the athletes, without rest.
The investigators will analyze: ratings of perceived exertion; activity of creatine kinase (CK); levels of the cytokine Interleukin-6 (IL-6), and maximum number of free squat reps in 1 minute.
Statistical analysis:
All data will be analyzed both in their absolute values and in relation to their percentage variation from the values obtained in the pre-WOD (baseline) assessments. The results obtained will be tested for normality using the Kolmogorov-Smirnov test. If data show normal distribution, the ANOVA test (one or two way depending on the outcome analyzed) with post-hoc Bonferroni will be used. The level of statistical significance will be p<0.05.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- The volunteers will be allocated to four interventions/situation: 1. Effective PBMT/sMF before WOD and placebo PBMT/sMF after WOD; 2. Placebo PBMT/sMF before WOD and effective PBMT/sMF after WOD; 3. Effective PBMT/sMF before WOD and effective PBMT/sMF after WOD; 4. Placebo PBMT/sMF before WOD and placebo PBMT/sMF after WOD. The order of the interventions will be randomized.
| Arm | Type | Receives |
|---|---|---|
| Effective PBMT/sMF before WOD and Placebo PBMT/sMF after WOD | Experimental | Device: Effective PBMT/sMF, Device: Placebo PBMT/sMFPBMT/sMF will be applied in two steps: effective PBMT/sMF will be applied before the WOD and placebo PBMT/sMF will be applied after the WOD. |
| Placebo PBMT/sMF before WOD and Effective PBMT/sMF after WOD | Experimental | Device: Effective PBMT/sMF, Device: Placebo PBMT/sMFPBMT/sMF will be applied in two steps: placebo PBMT/sMF will be applied before the WOD and effective PBMT/sMF will be applied after the WOD. |
| Effective PBMT/sMF before WOD and Effective PBMT/sMF after WOD | Experimental | Device: Effective PBMT/sMFPBMT/sMF will be applied in two steps: effective PBMT/sMF will be applied before the WOD and effective PBMT/sMF will be applied after the WOD. |
| Placebo PBMT/sMF before WOD and Placebo PBMT/sMF after WOD. | Placebo comparator | Device: Placebo PBMT/sMFPBMT/sMF will be applied in two steps: placebo PBMT/sMF will be applied before the WOD and placebo PBMT/sMF will be applied after the WOD. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Crossfit® amateur male athletes;
- who did not present a history of musculoskeletal injury in the regions of the hips, knees and calves in the month preceding the study;
- who were not using pharmacological agents;
- athletes should have been practicing the sport for at least 1 year;
- voluntarily commit to participate in all stages.
Key exclusion criteria (1 listed)
- who presented musculoskeletal or joint injuries during data collection.
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 |
|---|---|---|
| Effective PBMT/sMFA cluster with 20 diodes, manufactured by Multi Radiance Medical® (Solon, OH, USA), will be used: 4 diodes of 905 nm (1.25 average power, 50 W of peak power for each diode), 8 diodes of 850 nm (40 mW of average power for each diode) and 4 diodes of 633 nm (25 mW average power for each diode). Effective PBMT/sMF will be applied in direct contact with the skin and light pressure in: 4 sites in the knee extensor/hip flexor muscles, 3 sites in the knee flexor/hip extensor muscles and 1 site in the plantar flexor muscles. The effective PBMT/sMF will be applied to both lower limbs. The dose used for applications will be approximately 270 J for knee extensors/hip flexors, 180 J for knee flexors/hip extensors, and 60 J for plantar flexors. | Device | Effective PBMT/sMF before WOD and Effective PBMT/sMF after WOD, Effective PBMT/sMF before WOD and Placebo PBMT/sMF after WOD, Placebo PBMT/sMF before WOD and Effective PBMT/sMF after WOD |
| Placebo PBMT/sMFA cluster manufactured by Multi Radiance Medical® (Solon, OH, USA) with 20 diodes will be used: Placebo PBMT/sMF will be applied in direct contact with the skin and light pressure in: 4 sites in the knee extensor/hip flexor muscles, 3 sites in the knee flexor/hip extensor muscles and 1 site in the plantar flexor muscles. The placebo PBMT/sMF will be applied to both lower limbs. The dose used for applications will be approximately 0 J per diode. The sounds and signals emitted from the device as well as the information displayed on the screen will be identical, regardless of the type of treatment (active or placebo). | Device | Effective PBMT/sMF before WOD and Placebo PBMT/sMF after WOD, Placebo PBMT/sMF before WOD and Effective PBMT/sMF after WOD, Placebo PBMT/sMF before WOD and Placebo PBMT/sMF after WOD. |
Primary outcome
Change in functional capacity
Time frame: 1 minute post-treatment, 1hour, 24 hours and 48 hours after WOD (workout of the day).
The functional capacity will be measured by a maximum number of free squat repetitions within 1 minute.
3 secondary outcomes
Perception of exercise intensity
Time frame: 1 minute after WOD, 1 minute post-treatment, 1 hour, 24 hours and 48 hours after WOD (workout of the day).
Activity of creatine kinase (CK)
Time frame: 1 hour, 24 hours and 48 hours after WOD (workout of the day).
Levels of interleukin-6 (IL-6)
Time frame: 1 hour, 24 hours and 48 hours after WOD (workout of the day).
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 13 Jul 2020.
- Individual participant dataSharing planned: Yes. Data will be shared upon request addressed to the principal investigator
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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.
Ernesto Cesar Pinto Leal Junior, PhD 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 Effective PBMT/sMF in people with Muscle Strength, 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 5 inclusion and 1 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 13 Jul 2020. 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?
Change in functional capacity (time frame: 1 minute post-treatment, 1hour, 24 hours and 48 hours after WOD (workout of the day).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2020.