Clinical trial NCT03879226: Effects of Photobiomodulation Therapy in Aerobic Training and Detraining in Humans
Official title: Effects of Photobiomodulation Therapy in Aerobic Training and Detraining in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aerobic Endurance
Keywords: Photobiomodulation Therapy
Low-level Laser Therapy
Aerobic Endurance
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2019-03-18
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time until exhaustion.
timeFrame: 16 weeks - 4 weeks after completing the training (detraining period).
Secondary outcomes:
measure: Time until exhaustion.
timeFrame: 4, 8, and 12 weeks after starting the training period.
measure: Maximum oxygen consumption (VO2).
timeFrame: 4, 8, and 12 weeks after starting the training period, and at 4 weeks after completing the training (detraining period).
measure: Fat percentage.
timeFrame: 4, 8, and 12 weeks after starting the training period, and at 4 weeks after completing the training (detraining period).
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Laboratory of Phototherapy and Innovative Technologies in Health
state: Sao Paulo
Study officials:
affiliation: University of Nove de Julho
name: Ernesto Cesar Pinto Leal Junior, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Paiva PRV, Casalechi HL, Tomazoni SS, Machado CDSM, Ribeiro NF, Pereira AL, de Oliveira MFD, Alves MNDS, Dos Santos MC, Takara IET, Miranda EF, de Carvalho PTC, Leal-Junior ECP. Does the combination of photobiomodulation therapy (PBMT) and static magnetic fields (sMF) potentiate the effects of aerobic endurance training and decrease the loss of performance during detraining? A randomised, triple-blinded, placebo-controlled trial. BMC Sports Sci Med Rehabil. 2020 Apr 10;12:23. doi: 10.1186/s13102-020-00171-2. eCollection 2020.
citation: de Paiva PRV, Casalechi HL, Tomazoni SS, Machado CDSM, Miranda EF, Ribeiro NF, Pereira AL, da Costa AS, Dias LB, Souza BCG, Aguiar Lino MM, de Carvalho PTC, Leal-Junior ECP. Effects of photobiomodulation therapy in aerobic endurance training and detraining in humans: Protocol for a randomized placebo-controlled trial. Medicine (Baltimore). 2019 May;98(18):e15317. doi: 10.1097/MD.0000000000015317.