Skip to main content
OpenTrials
Completed

NCT Number: NCT03879226

Effects of Photobiomodulation Therapy in Aerobic Training and Detraining in Humans

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Laboratory of Phototherapy and Innovative Technologies in Health

São Paulo, 01504-001, Brazil

About this study

It will be carried out a randomized, triple-blind, placebo-controlled trial.

Seventy-two volunteers will be randomly allocated to four experimental groups:

  • PBMT before and after the aerobic training sessions and PBMT during the detraining period;
  • PBMT before and after the aerobic training sessions and placebo during the detraining period;
  • Placebo before and after the aerobic training sessions and PBMT during the detraining period;
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy men;
  • Aged from 18 to 35 years;
  • Complete at least 80% of the study procedures will be included in the study.

Exclusion criteria

  • History of musculoskeletal injury in the hip and knee regions in the 2 months before the study;
  • Become injured during the study;
  • Regularly use pharmacological agents and/ or nutritional supplements;
  • Signs and symptoms of any neurological, metabolic, inflammatory, pulmonary, oncological, or cardiovascular disease that may limit the execution of high-intensity exercises.

Treatment and study plan

PBMT

Device

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

Device

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.

Primary outcomes

  1. Time until exhaustion.

    Time frame: 16 weeks - 4 weeks after completing the training (detraining period).

    The time until exhaustion will be measured by the software of ergospirometry system.

Secondary outcomes

  1. Time until exhaustion.

    Time frame: 4, 8, and 12 weeks after starting the training period.

    The time until exhaustion will be measured by the software of ergospirometry system.

  2. Maximum oxygen consumption (VO2).

    Time frame: 4, 8, and 12 weeks after starting the training period, and at 4 weeks after completing the training (detraining period).

    The rates of maximum oxygen consumption will be measured by an ergospirometry test.

  3. Fat percentage.

    Time frame: 4, 8, and 12 weeks after starting the training period, and at 4 weeks after completing the training (detraining period).

    Fat percentage will be measured by diameters, perimeters, and skinfolds.

Sponsors and collaborators

Lead sponsor

University of Nove de Julho

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 18, 2019
Registry last updated
Sep 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.