Effects of Photobiomodulation Therapy in Aerobic Training and Detraining in Humans
Condition: Aerobic Endurance
Study type: Interventional

Summary: 
      In last years it has been demonstrated that photobiomodulation therapy (PBMT) has ergogenic
      effects. However some key aspects, such as the potentially beneficial effects of PBMT during
      the detraining period still remain unknown.

      Therefore, the aim of this project is to evaluate the effects of PBMT applied before and
      after aerobic training sessions and during the detraining period.
    

Detailed description: 
      It will be carried out a randomized, triple-blind, placebo-controlled trial.

      Seventy-two volunteers will be randomly allocated to four experimental groups:

        1. PBMT before and after the aerobic training sessions and PBMT during the detraining
           period;

        2. PBMT before and after the aerobic training sessions and placebo during the detraining
           period;

        3. Placebo before and after the aerobic training sessions and PBMT during the detraining
           period;

        4. Placebo before and after the aerobic training sessions and placebo during the detraining
           period .

      The individuals randomly allocated to the different groups will be subjected to 12
      consecutive weeks of aerobic training performed on a treadmill 3 times a week on
      non-consecutive days. Each training session will last 30 minutes, with an intensity ranging
      from 85 to 90% maximum heart rate. PBMT or placebo will be applied before and after each
      training session. After the 12-week training period, the volunteers will receive the
      application of PBMT or placebo depending on the group to which they are allocated for 4 weeks
      (3 times a week) without training.

      The data will be collected by a blind assessor. It will be analyzed time of the exercise
      (time until exhaustion), maximum oxygen consumption in absolute and relative values in
      relation to body mass (VO2max). Moreover, it will be evaluated the body composition. The
      evaluations will be performed before starting the protocol (baseline) and after 4, 8, and 12
      weeks of training. They will also be performed after 4 weeks without training (detraining
      period).

      The findings will be tested for their normality using the Shapiro-Wilk test. Parametric data
      will be expressed as mean and standard deviation and nonparametric data as median and
      respective upper and lower limits. Parametric data will be analyzed by two-way repeated
      measures analysis of variance (ANOVA; time versus experimental group) with post-hoc
      Bonferroni correction. Non-parametric data will be analyzed using the Friedman test and,
      secondarily, the Wilcoxon signed-rank test. Data will be analyzed in terms of both their
      absolute values and their relationship to the percentage change based on the values
      established in the baseline tests. The significance level will be set at p<0.05.
    

Intervention name(s): PBMT; Placebo
Intervention type(s): Device; Device
Intervention description(s): PBMT will be applied bilaterally using the direct contact method with light pressure on the skin at different sites, namely 9 sites on the knee extensor muscles, 6 sites on the knee flexor muscles, and 2 sites on the plantar flexor muscles. A 12-diode cluster, with 4 905-nm laser diodes (12.5W peak power for each diode), 4 875-nm LED diodes (17.5 mW mean power for each diode), and 4 640-nm LED diodes (15 mW mean power for each diode), manufactured by Multi Radiance Medical® (Solon, OH, USA), will be used to apply the PBMT. The dose used for the applications during the training and/or detraining periods will be 30 Joules (J) per site (510 J per lower limb). PBMT will be applied before and after each training session and during the detraining period, depending on the group to which the volunteers are allocated.; Placebo will be applied bilaterally using the direct contact method with light pressure on the skin at different sites, namely 9 sites on the knee extensor muscles, 6 sites on the knee flexor muscles, and 2 sites on the plantar flexor muscles. The placebo PBMT will per performed using the dose of 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 will be applied before and after each training session and during the detraining period, depending on the group to which the volunteers are allocated.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Photobiomodulation Therapy; Low-level Laser Therapy; Aerobic Endurance