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

Primary Purpose

Menstrual Cycle Disorder

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Photobiomodulation
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menstrual Cycle Disorder focused on measuring Menstrual cycle, Photobiomodulation therapy, Fatigue, Clinical Trial

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Rinaldo Roberto de Jesus Guirro
  • Universidade de São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

G-FBM-CEN

G - Sham - CEN

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Fatigue Strength
Distance traveled during incremental testing (km)

Secondary Outcome Measures

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

Full Information

First Posted
February 19, 2020
Last Updated
March 17, 2023
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT04281446
Brief Title
Physical Performance of Women at Different Stages of the Menstrual Cycle, and Photobiomodulation Therapy
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
August 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menstrual Cycle Disorder
Keywords
Menstrual cycle, Photobiomodulation therapy, Fatigue, Clinical Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
G-FBM-CEN
Arm Type
Experimental
Arm Description
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.
Arm Title
G - Sham - CEN
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Photobiomodulation
Intervention Description
Application of light at specific wavelength for interaction with biological tissue
Primary Outcome Measure Information:
Title
Fatigue Strength
Description
Distance traveled during incremental testing (km)
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
Muscle Performance
Description
Quantitative assessment of muscle performance performed by isokinetic dynamometer (N/m; W, %)
Time Frame
20 minutes
Title
Subjective Perception of Effort
Description
Modified 10-point Borg scale The scale assesses the level of effort, with 0 being no effort and 10 being the maximum physical effort.
Time Frame
20 minutes
Title
Ventilatory variables
Description
VO2máx (ml.kg-1.min-1)
Time Frame
20 minutes
Title
Lactate
Description
Lactate threshold (iLL) and anaerobic threshold (iLAN) (mmol/L)
Time Frame
20 minutes
Title
Body Temperature
Description
Thermographic evaluation (°C)
Time Frame
15 minutes
Title
Body water level
Description
Bioimpedance Evaluation (%)
Time Frame
10 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriela de Carvalho, Ms.
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rinaldo Roberto de Jesus Guirro
City
Ribeirão Preto
State/Province
SP
ZIP/Postal Code
14049-900
Country
Brazil
Facility Name
Universidade de São Paulo
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14049-900
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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

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