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

NCT04281446 | Completed DMC

• 1 other identifier: U1111-1143-7630
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

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.

Conditions

Menstrual Cycle Disorder

Keywords

Menstrual cycle; Photobiomodulation therapy; Fatigue; Clinical Trial

Outcome Measures

Primary Outcomes (1)

• Fatigue Strength

  Distance traveled during incremental testing (km)

  20 minutes

Secondary Outcomes (6)

• Muscle Performance

  20 minutes

• Subjective Perception of Effort

  20 minutes

• Ventilatory variables

  20 minutes

• Lactate

  20 minutes

• Body Temperature

  15 minutes

Study Arms (2)

G-FBM-CEN

EXPERIMENTAL

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

G - Sham - CEN

SHAM COMPARATOR

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

Interventions

Photobiomodulation DEVICE

Application of light at specific wavelength for interaction with biological tissue

G - Sham - CEN; G-FBM-CEN

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women
• to 35 years
• Healthy
• Physically Active (150 min / week)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (2)

Rinaldo Roberto de Jesus Guirro

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

Universidade de São Paulo

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

MeSH Terms

Conditions

Menstruation Disturbances; Fatigue

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Gabriela de Carvalho, Ms.

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: P.h.D Professor

Model Details: 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).

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 24, 2020
• Study Start: October 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: August 10, 2021
• Last Updated: March 21, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)