Effects of Photobiomodulation Therapy Combined With Static Magnetic Field in CrossFit® Athletes

NCT ID: NCT04349085

Last Updated: 2020-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-17

Study Completion Date

2020-05-10

Brief Summary

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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

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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

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Muscle Strength

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
A researcher will program the device (placebo or PMBT) and will be instructed not to inform the volunteers or other researchers as to the type of treatment (PMBT or placebo). Therefore, the researcher responsible for the treatment will be blinded to the type of treatment being administered to the volunteers. 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 (placebo or PBMT).

Study Groups

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Effective PBMT/sMF before WOD and Placebo PBMT/sMF after WOD

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.

Group Type EXPERIMENTAL

Effective PBMT/sMF

Intervention Type DEVICE

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/sMF

Intervention Type DEVICE

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).

Placebo PBMT/sMF before WOD and Effective PBMT/sMF after WOD

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.

Group Type EXPERIMENTAL

Effective PBMT/sMF

Intervention Type DEVICE

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/sMF

Intervention Type DEVICE

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).

Effective PBMT/sMF before WOD and Effective PBMT/sMF after WOD

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.

Group Type EXPERIMENTAL

Effective PBMT/sMF

Intervention Type DEVICE

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/sMF before WOD and Placebo PBMT/sMF after WOD.

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.

Group Type PLACEBO_COMPARATOR

Placebo PBMT/sMF

Intervention Type DEVICE

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).

Interventions

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Effective PBMT/sMF

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.

Intervention Type DEVICE

Placebo PBMT/sMF

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).

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* who presented musculoskeletal or joint injuries during data collection.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Nove de Julho

OTHER

Sponsor Role lead

Responsible Party

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Ernesto Cesar Pinto Leal Junior

Full professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ernesto Cesar Pinto Leal Junior, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nove de Julho

Locations

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Laboratory of Phototherapy and Innovative Technologies in Health

São Paulo, , Brazil

Site Status

Countries

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Brazil

Other Identifiers

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3.360.743

Identifier Type: -

Identifier Source: org_study_id

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