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Completed

NCT Number: NCT04281446

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

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Key information

Conditions

Menstrual Cycle Disorder Fatigue Menstruation Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rinaldo Roberto de Jesus Guirro, Ribeirão Preto, São Paulo, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Photobiomodulation

Device

Application of light at specific wavelength for interaction with biological tissue

Primary outcomes

  1. Fatigue Strength

    Time frame: 20 minutes

    Distance traveled during incremental testing (km)

Secondary outcomes

  1. Muscle Performance

    Time frame: 20 minutes

    Quantitative assessment of muscle performance performed by isokinetic dynamometer (N/m; W, %)

  2. 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.

  3. Ventilatory variables

    Time frame: 20 minutes

    VO2máx (ml.kg-1.min-1)

  4. Lactate

    Time frame: 20 minutes

    Lactate threshold (iLL) and anaerobic threshold (iLAN) (mmol/L)

  5. Body Temperature

    Time frame: 15 minutes

    Thermographic evaluation (°C)

  6. Body water level

    Time frame: 10 minutes

    Bioimpedance Evaluation (%)

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 24, 2020
Registry last updated
Mar 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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