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Clinical Trials/NCT04281446
NCT04281446
Completed
Not Applicable

Mapping the Physical Performance of Women From Endogenous Ovarian Cycles at Different Stages of the Menstrual Cycle, and the Respective Influence of Photobiomodulation Therapy

University of Sao Paulo2 sites in 1 country27 target enrollmentOctober 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Menstrual Cycle Disorder
Sponsor
University of Sao Paulo
Enrollment
27
Locations
2
Primary Endpoint
Fatigue Strength
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2020
End Date
August 10, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rinaldo Roberto de Jesus Guirro

P.h.D Professor

University of Sao Paulo

Eligibility Criteria

Inclusion Criteria

  • 18 to 35 years
  • Physically Active (150 min / week)

Exclusion Criteria

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

Outcomes

Primary Outcomes

Fatigue Strength

Time Frame: 20 minutes

Distance traveled during incremental testing (km)

Secondary Outcomes

  • Body water level(10 minutes)
  • Body Temperature(15 minutes)
  • Muscle Performance(20 minutes)
  • Subjective Perception of Effort(20 minutes)
  • Ventilatory variables(20 minutes)
  • Lactate(20 minutes)

Study Sites (2)

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