Photobiomodulation Therapy Combined With Static Magnetic Field on the Subsequent Performance

NCT ID: NCT04934709

Last Updated: 2021-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2015-09-30

Brief 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.

Detailed 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.

Conditions

Skeletal Muscle Performance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

PBMT-sMF

Volunteers underwent intervention (active PBMT-sMF) in the non-dominant lower limb. A single application was performed at each phase of the trial, between the first and second set of the exercise protocol.

Group Type: EXPERIMENTAL

Active PBMT-sMF

Intervention Type: DEVICE

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

Volunteers underwent intervention (placebo PBMT-sMF) in the non-dominant lower limb. A single application was performed at each phase of the trial, between the first and second set of the exercise protocol.

Group Type: PLACEBO_COMPARATOR

Placebo PBMT-sMF

Intervention Type: DEVICE

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).

Interventions

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.

Intervention Type: DEVICE

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).

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nove de Julho

OTHER

Sponsor Role: lead

Responsible Party

Ernesto Cesar Pinto Leal Junior

Full professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Laboratory of Phototherapy and Innovative Technologies in Health

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

665332

Identifier Type: -

Identifier Source: org_study_id