Effects of Photobiomodulation Therapy in Aerobic Training and Detraining in Humans

Aerobic Endurance Clinical Trial

Official title:

Effects of Photobiomodulation Therapy in Aerobic Training and Detraining in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03879226
• Other study ID #: 1781602-2
• Status: Completed
• Phase: N/A
• Start date: March 25, 2019
• Est. completion date: August 25, 2019

Study information

• Verified date: August 2019
• Source: University of Nove de Julho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 25, 2019
• Est. primary completion date: August 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aerobic Endurance

Intervention

Device:
• PBMT
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
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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of Nove de Julho	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time until exhaustion.	The time until exhaustion will be measured by the software of ergospirometry system.	16 weeks - 4 weeks after completing the training (detraining period).
Secondary	Time until exhaustion.	The time until exhaustion will be measured by the software of ergospirometry system.	4, 8, and 12 weeks after starting the training period.
Secondary	Maximum oxygen consumption (VO2).	The rates of maximum oxygen consumption will be measured by an ergospirometry test.	4, 8, and 12 weeks after starting the training period, and at 4 weeks after completing the training (detraining period).
Secondary	Fat percentage.	Fat percentage will be measured by diameters, perimeters, and skinfolds.	4, 8, and 12 weeks after starting the training period, and at 4 weeks after completing the training (detraining period).