Menstrual Cycle DisorderNCT04281446
Physical Performance of Women at Different Stages of the Menstrual Cycle, and Photobiomodulation Therapy
A study testing Photobiomodulation in people with Menstrual Cycle Disorder, run by University of Sao Paulo at 2 sites in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstrual Cycle Disorder
- What is being tested?
- Photobiomodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 2 sitesBrazil
- Study dates
- 1 Oct 2020to 10 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women
- 18 to 35 years
- Healthy
- Physically Active (150 min / week)
Who cannot join
- Eating disorders;
- Hormonal disorders;
- Amenorrhea;
- Pregnancy;
- Polycystic ovary;
- Endometriosis;
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- Tumors;
- Musculoskeletal injury in the last 6 months;
- Cardiorespiratory disease;
- Use of alcohol and illegal drugs during the study.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Rinaldo Roberto de Jesus Guirro
Ribeirão Preto, São Paulo, 14049-900
Universidade de São Paulo
Ribeirão Preto, São Paulo, 14049-900
About this study
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
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.
Read the 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.
- Conditions
- Menstrual Cycle Disorder
- Being tested
- Photobiomodulation
- Keywords
- Menstrual cycle, Photobiomodulation therapy, Fatigue, Clinical Trial
- Medical subject headings
- Menstruation Disturbances, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotobiomodulationDevice
Application of light at specific wavelength for interaction with biological tissue
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Strength
Distance traveled during incremental testing (km)
Measured: 20 minutes
Secondary outcomes (6)
Muscle Performance
Quantitative assessment of muscle performance performed by isokinetic dynamometer (N/m; W, %)
Measured: 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.
Measured: 20 minutes
Ventilatory variables
VO2máx (ml.kg-1.min-1)
Measured: 20 minutes
Lactate
Lactate threshold (iLL) and anaerobic threshold (iLAN) (mmol/L)
Measured: 20 minutes
Body Temperature
Thermographic evaluation (°C)
Measured: 15 minutes
Body water level
Bioimpedance Evaluation (%)
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start1 Oct 2020
- Primary completion1 Jul 2021
- Study completion10 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual Cycle DisorderStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rinaldo Roberto de Jesus Guirro, University of Sao Paulo
- Investigators
- Gabriela de Carvalho, Ms., Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04281446
- Sponsor's protocol ID
- U1111-1143-7630
- Status last verified
- Mar 2023
- First submitted
- 19 Feb 2020
- Last updated
- 21 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04281446
- Acronym / sponsor ID
- U1111-1143-7630
- Conditions
- Menstrual Cycle Disorder
- Keywords
- Menstrual cycle, Photobiomodulation therapy, Fatigue, Clinical Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 10 Aug 2021 (actual)
- First posted
- 24 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| G-FBM-CEN | Experimental | Device: PhotobiomodulationPhotobiomodulation 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. |
| G - Sham - CEN | Sham comparator | Device: PhotobiomodulationSham 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women
- 18 to 35 years
- Healthy
- Physically Active (150 min / week)
Key exclusion criteria (10 listed)
- Eating disorders;
- Hormonal disorders;
- Amenorrhea;
- Pregnancy;
- Polycystic ovary;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhotobiomodulationApplication of light at specific wavelength for interaction with biological tissue | Device | G - Sham - CEN, G-FBM-CEN |
Primary outcome
Fatigue Strength
Time frame: 20 minutes
Distance traveled during incremental testing (km)
6 secondary outcomes
Muscle Performance
Time frame: 20 minutes
Subjective Perception of Effort
Time frame: 20 minutes
Ventilatory variables
Time frame: 20 minutes
Lactate
Time frame: 20 minutes
Body Temperature
Time frame: 15 minutes
Body water level
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriela de Carvalho, Ms. principal investigator
University of Sao Paulo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation in people with Menstrual Cycle Disorder, run by University of Sao Paulo at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Strength (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.