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

NCT ID: NCT04281446

Last Updated: 2023-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2021-08-10

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.

Conditions

Menstrual Cycle Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

G-FBM-CEN

Photobiomodulation application in women of endogenous cycle. Antares® equipment (IBRAMED, Amparo-SP, Brazil) will be used, by means of a cluster, with two wavelengths (13 LEDs of 630 nm, 300 mW + 13 LEDs of 850 nm, 500 mW), being its area of 80 cm² contact, acting 180 J of energy being applied at 15 points on each thigh - 9 in the anterior region and 6 in the posterior region, in addition to 2 points in the gastrocnemius.

Group Type: EXPERIMENTAL

Photobiomodulation

Intervention Type: DEVICE

Application of light at specific wavelength for interaction with biological tissue

G - Sham - CEN

Sham Photobiomodulation (disabled) application in women of endogenous cycle.

The procedure and equipment will be the same as for the experimental groups, however no dosage will be applied:

Antares® equipment (IBRAMED, Amparo-SP, Brazil) will be used, by means of a cluster, with two wavelengths (13 LEDs of 630 nm, 300 mW + 13 LEDs of 850 nm, 500 mW), being its area of 80 cm² contact, with 0 J of energy being applied at 15 points on each thigh - 9 in the anterior region and 6 in the posterior region, in addition to 2 points in the gastrocnemius.

Group Type: SHAM_COMPARATOR

Photobiomodulation

Intervention Type: DEVICE

Application of light at specific wavelength for interaction with biological tissue

Interventions

Photobiomodulation

Application of light at specific wavelength for interaction with biological tissue

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Rinaldo Roberto de Jesus Guirro

P.h.D Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gabriela de Carvalho, Ms.

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

Rinaldo Roberto de Jesus Guirro

Ribeirão Preto, São Paulo, Brazil

Universidade de São Paulo

Ribeirão Preto, São Paulo, Brazil

Countries

Brazil

Other Identifiers

U1111-1143-7630

Identifier Type: -

Identifier Source: org_study_id