- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04349085
Effects of Photobiomodulation Therapy Combined With Static Magnetic Field in CrossFit® Athletes
Effects of Photobiomodulation Therapy Combined With Static Magnetic Field Applied in Different Moments on Performance and Muscle Recovery in CrossFit® Athletes
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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São Paulo, Brazil, 01504-001
- Laboratory of Phototherapy and Innovative Technologies in Health
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
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).
|
Experimental: 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.
|
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.
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).
|
Experimental: 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.
|
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 Comparator: 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.
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 minute post-treatment, 1hour, 24 hours and 48 hours after WOD (workout of the day).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
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.
|
1 minute after WOD, 1 minute post-treatment, 1 hour, 24 hours and 48 hours after WOD (workout of the day).
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Activity of creatine kinase (CK)
Time Frame: 1 hour, 24 hours and 48 hours after WOD (workout of the day).
|
The activity of CK will be analyzed by spectrophotometry and using specific reagent kits from the blood samples collected.
|
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).
|
The levels of interleukin-6 will be analyzed by enzyme-linked immunosorbent assay (ELISA) and using specific reagent kits from the blood samples collected.
|
1 hour, 24 hours and 48 hours after WOD (workout of the day).
|
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 (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 3.360.743
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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