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

NCT04349085 | Completed FDA Device

• 1 other identifier: 3.360.743
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Muscle Strength

Keywords

Photobiomodulation Therapy; Low-level Laser Therapy; Static Magnectic Fields; CrossFit®; Strength Training

Outcome Measures

Primary Outcomes (1)

• Change in functional capacity

  The functional capacity will be measured by a maximum number of free squat repetitions within 1 minute.

  1 minute post-treatment, 1hour, 24 hours and 48 hours after WOD (workout of the day).

Secondary Outcomes (3)

• Perception of exercise intensity

  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)

  1 hour, 24 hours and 48 hours after WOD (workout of the day).

• Levels of interleukin-6 (IL-6)

  1 hour, 24 hours and 48 hours after WOD (workout of the day).

Study Arms (4)

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.

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.

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.

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.

Device: Placebo PBMT/sMF

Interventions

Effective PBMT/sMF 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.

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/sMF 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 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.

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• who presented musculoskeletal or joint injuries during data collection.

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Laboratory of Phototherapy and Innovative Technologies in Health

São Paulo, 01504-001, Brazil

Location

Study Officials

• Ernesto Cesar Pinto Leal Junior, PhD

  University of Nove de Julho

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Model Details: 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.

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 16, 2020
• Study Start: April 17, 2020
• Primary Completion: May 10, 2020
• Study Completion: May 10, 2020
• Last Updated: July 13, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

BR (1)