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Physical Performance of Women at Different Stages of the Menstrual Cycle, and Photobiomodulation Therapy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04281446
Enrollment
27
Registered
2020-02-24
Start date
2020-10-01
Completion date
2021-08-10
Last updated
2023-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menstrual Cycle Disorder

Keywords

Menstrual cycle, Photobiomodulation therapy, Fatigue, Clinical Trial

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.

Interventions

DEVICEPhotobiomodulation

Application of light at specific wavelength for interaction with biological tissue

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

The randomization and allocation of participants will be performed by a researcher who will not have access to evaluations and data collection. The interventions will be carried out by the researcher who made the allocation, and data collection by a second researcher, who is blinded to the allocation of the participants. Participants will not know about their allocation during the collection process and during the intervention they will wear a mask covering their eyes.

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).

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Fatigue Strength20 minutesDistance traveled during incremental testing (km)

Secondary

MeasureTime frameDescription
Subjective Perception of Effort20 minutesModified 10-point Borg scale The scale assesses the level of effort, with 0 being no effort and 10 being the maximum physical effort.
Ventilatory variables20 minutesVO2máx (ml.kg-1.min-1)
Muscle Performance20 minutesQuantitative assessment of muscle performance performed by isokinetic dynamometer (N/m; W, %)
Body Temperature15 minutesThermographic evaluation (°C)
Body water level10 minutesBioimpedance Evaluation (%)
Lactate20 minutesLactate threshold (iLL) and anaerobic threshold (iLAN) (mmol/L)

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026