Clinical trial NCT04281446: Physical Performance of Women at Different Stages of the Menstrual Cycle, and Photobiomodulation Therapy
Official title: Mapping the Physical Performance of Women From Endogenous Ovarian Cycles at Different Stages of the Menstrual Cycle, and the Respective Influence of Photobiomodulation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menstrual Cycle Disorder
Keywords: Menstrual cycle
Photobiomodulation therapy
Fatigue
Clinical Trial
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2020-02-24
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The randomization and allocation of participants will be performed at beginning of the project, allocating the participants in 2 groups:

* Endogenous ovarian cycle Photobiomodulation Group(G-FBM-CEN);
* Endogenous ovarian cycle Sham Group (G - Sham - CEN).
Primary purpose: TREATMENT

Brief summary: Hormonal fluctuations present during the ovarian cycle may have a strong influence on physiological and psychological aspects on physical performance in women. The aspects surrounding performance and ovarian cycles in women during different phases of the cycle, are still current and should be debated in the literature, as the available evidence has conflicting results. In addition to the above, new ergogenic methods have been studied to improve the sports scenario in different populations. Research on the use of ergogenic electrophysical resources so that hormonal effects may possibly be mitigated, allowing women to use this resource and improving their physical performance is still scarce in the current literature.

Detailed description: Objective: To evaluate the physical performance of women during different phases of the ovarian cycle and the influence of photobiomodulation therapy in this setting. Methods: The research will be conducted in two subprojects - Subproject I is a cross-sectional study. Initially the participants will be evaluated in two phases separately, being the first and second day within the ovarian cycle in the follicular phase (FF) and the third and fourth day in the luteal phase (FL). The aspects of body composition, body water volume and skin temperature by infrared thermography will be evaluated, and the physical performance evaluation will be constituted by the evaluation of the muscular performance by isokinetic dynamometer, and by a treadmill supramaximal effort test. , together with analysis of VO2max and blood lactate levels. Subproject II is a double-blind placebo-controlled randomized clinical trial. After completion of subproject I, during the next ovarian cycle within the participants will return to conduct the second part of the study, which will analyze the influence of photobiomodulation therapy on the physical performance of women within their menstrual cycle, related to low hormone rate ( FF). 200 J of energy will be applied before each evaluation, which is muscle performance and endurance. The tests will be performed in the same order, following the same protocol in both phases of the study. For data analysis, a normality test will be used to verify the distribution and statistical tests consistent with the appropriate intra and intergroup comparisons, being considered two factors in the comparisons, time and group. A significance level of 5% will be adopted. The effect size will be calculated by Cohens'd.

Eligibility criteria: Inclusion Criteria:

* Women
* 18 to 35 years
* Healthy
* Physically Active (150 min / week)

Exclusion Criteria:

* Eating disorders;
* Hormonal disorders;
* Amenorrhea;
* Pregnancy;
* Polycystic ovary;
* Endometriosis;
* Tumors;
* Musculoskeletal injury in the last 6 months;
* Cardiorespiratory disease;
* Use of alcohol and illegal drugs during the study.

Primary outcomes:
measure: Fatigue Strength
timeFrame: 20 minutes
Secondary outcomes:
measure: Muscle Performance
timeFrame: 20 minutes
measure: Subjective Perception of Effort
timeFrame: 20 minutes
measure: Ventilatory variables
timeFrame: 20 minutes
measure: Lactate
timeFrame: 20 minutes
measure: Body Temperature
timeFrame: 15 minutes
measure: Body water level
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Rinaldo Roberto de Jesus Guirro
state: SP
city: Ribeirão Preto
country: Brazil
facility: Universidade de São Paulo
state: São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Gabriela de Carvalho, Ms.
role: PRINCIPAL_INVESTIGATOR
References: