Physical Performance of Women at Different Stages of the Menstrual Cycle, and Photobiomodulation Therapy
Condition: Menstrual Cycle Disorder
MeSH terms: Menstruation Disturbances
Study type: Interventional

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.
    

Intervention name(s): Photobiomodulation
Intervention type(s): Device
Intervention description(s): Application of light at specific wavelength for interaction with biological tissue
Allocation: Randomized
Intervention model: Parallel Assignment
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).
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Menstrual cycle; Photobiomodulation therapy; Fatigue; Clinical Trial