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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04934709
Other study ID # 665332
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2015
Est. completion date September 2015

Study information

Verified date June 2021
Source University of Nove de Julho
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

There is evidence about the effects of photobiomodulation therapy (PBMT) alone and combined with static magnetic field (PBMT-sMF) on skeletal muscle fatigue, physical performance and post-exercise recovery in different types of exercise protocols and sports activity. However, it is unknown the effects of PBMT-sMF to improve the subsequent performance after a first set of exercise. Therefore, the aim of this study was to investigate the effects of PBMT-sMF, applied between two sets of exercises, on the subsequent physical performance.


Description:

A randomized, crossover, triple-blinded (assessors, therapist and volunteers), placebo-controlled trial was carried out. Healthy non-athletes' male volunteers were randomized and treated with a single application of PBMT-sMF and placebo between two sets of an exercise protocol performed on isokinetic dynamometer. The order of interventions was randomized. The primary outcome was fatigue index, measured by isokinetic dynamometer during the exercise protocol. The secondary outcomes were total work and peak torque measured by isokinetic dynamometer during the exercise protocol; and blood lactate, measured by blood samples collected before, 3 minutes after the first set of the exercise protocol, 3 minutes after the application of the intervention and 3 minutes after the second set of the exercise protocol. Statistical analysis: The findings were tested for normality using the Kolmogorov-Smirnov test and were determined to have a normal distribution. Data were expressed as the mean and standard deviation, and a two-way repeated measures ANOVA was performed to test between-group differences at each timepoint (treatment effects), mean difference (MD) and 95% confidence intervals (CI), followed by the Bonferroni post hoc test. The significance level was set at p < 0.05.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date September 2015
Est. primary completion date September 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 35 Years
Eligibility Inclusion criteria: - Male healthy volunteers; - Non-athletes or those who practiced physical activity up to once a week; - Aged 18-35 years. Exclusion criteria - History of musculoskeletal injuries in the hip and knee regions in the two months prior to the study; - Use of pharmacological agents and nutritional supplements; - Chronic joint disease in the non-dominant lower limb.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Active PBMT-sMF
PBMT-sMF was applied employing the Multi Radiance Medical Super Pulsed Laser MR4 console (Solon, Ohio, USA) with a LaserShower cluster probe as emitter. Six different sites of the knee extensor muscles (two medial, two lateral and two central points) were irradiated at the same time.
Placebo PBMT-sMF
Placebo PBMT-sMF was applied employing the Multi Radiance Medical Super Pulsed Laser MR4 console (Solon, Ohio, USA) with a LaserShower cluster probe as emitter, but without any emission of therapeutic dose. Placebo PBMT-sMF was applied at six different sites of the knee extensor muscles (two medial, two lateral and two central points).

Locations

Country Name City State
Brazil Laboratory of Phototherapy and Innovative Technologies in Health São Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Nove de Julho

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fatigue index Variable provided directly by the isokinetic dynamometer during the exercise protocol. 1 minute after the end of exercise protocol.
Secondary Total work Variable provided directly by the isokinetic dynamometer during the exercise protocol. 1 minute after the end of exercise protocol.
Secondary Peak torque Variable provided directly by the isokinetic dynamometer during the exercise protocol. 1 minute after the end of exercise protocol.
Secondary Blood lactate Measured by blood samples. 3 minutes after the first set of the exercise protocol, 3 minutes after the application of the intervention and 3 minutes after the second set of the exercise protocol.
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