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

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.

Study Overview

• Status: Completed
• Conditions: Menstrual Cycle Disorder
• Intervention / Treatment: Device: Photobiomodulation

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Ribeirão Preto, SP, Brazil, 14049-900
      • Rinaldo Roberto de Jesus Guirro
  • São Paulo
    • Ribeirão Preto, São Paulo, Brazil, 14049-900
      • Universidade de Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Photobiomodulation; Application of light at specific wavelength for interaction with biological tissue
Sham Comparator: 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.	Device: Photobiomodulation; Application of light at specific wavelength for interaction with biological tissue

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue Strength	Distance traveled during incremental testing (km)	20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle Performance	Quantitative assessment of muscle performance performed by isokinetic dynamometer (N/m; W, %)	20 minutes
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
Ventilatory variables	VO2máx (ml.kg-1.min-1)	20 minutes
Lactate	Lactate threshold (iLL) and anaerobic threshold (iLAN) (mmol/L)	20 minutes
Body Temperature	Thermographic evaluation (°C)	15 minutes
Body water level	Bioimpedance Evaluation (%)	10 minutes

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Principal Investigator: Gabriela de Carvalho, Ms., University of Sao Paulo

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): August 10, 2021

Study Registration Dates

• First Submitted: February 19, 2020
• First Submitted That Met QC Criteria: February 19, 2020
• First Posted (Actual): February 24, 2020

Study Record Updates

• Last Update Posted (Actual): March 21, 2023
• Last Update Submitted That Met QC Criteria: March 17, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Fatigue; Clinical Trial; Menstrual cycle; Photobiomodulation therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Menstruation Disturbances
• Other Study ID Numbers: U1111-1143-7630

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No