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

March 17, 2023 updated by: Rinaldo Roberto de Jesus Guirro, University of Sao Paulo

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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 São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fatigue Strength
Time Frame: 20 minutes
Distance traveled during incremental testing (km)
20 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Muscle Performance
Time Frame: 20 minutes
Quantitative assessment of muscle performance performed by isokinetic dynamometer (N/m; W, %)
20 minutes
Subjective Perception of Effort
Time Frame: 20 minutes

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
Time Frame: 20 minutes
VO2máx (ml.kg-1.min-1)
20 minutes
Lactate
Time Frame: 20 minutes
Lactate threshold (iLL) and anaerobic threshold (iLAN) (mmol/L)
20 minutes
Body Temperature
Time Frame: 15 minutes
Thermographic evaluation (°C)
15 minutes
Body water level
Time Frame: 10 minutes
Bioimpedance Evaluation (%)
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sao Paulo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gabriela de Carvalho, Ms., University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 10, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 19, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings