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

Menstrual Cycle Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04281446
• Other study ID #: U1111-1143-7630
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: August 10, 2021

Study information

• Verified date: March 2023
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: August 10, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Menstrual Cycle Disorder
• Menstruation Disturbances

Intervention

Device:
• Photobiomodulation
Application of light at specific wavelength for interaction with biological tissue

Locations

Country	Name	City	State
Brazil	Rinaldo Roberto de Jesus Guirro	Ribeirão Preto	SP
Brazil	Universidade de São Paulo	Ribeirão Preto	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue Strength	Distance traveled during incremental testing (km)	20 minutes
Secondary	Muscle Performance	Quantitative assessment of muscle performance performed by isokinetic dynamometer (N/m; W, %)	20 minutes
Secondary	Subjective Perception of Effort	Modified 10-point Borg scale; The scale assesses the level of effort, with 0 being no effort and 10 being the maximum physical effort.	20 minutes
Secondary	Ventilatory variables	VO2máx (ml.kg-1.min-1)	20 minutes
Secondary	Lactate	Lactate threshold (iLL) and anaerobic threshold (iLAN) (mmol/L)	20 minutes
Secondary	Body Temperature	Thermographic evaluation (°C)	15 minutes
Secondary	Body water level	Bioimpedance Evaluation (%)	10 minutes