Effets of the Hormonal Cycle and Contraception on Cardiovascular System and Sport Performance
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Maximal Oxygen Uptake (VO₂max) Assessed by Cardiopulmonary Exercise Testing
研究概览
简要总结
The present study aims to understand the impact of the hormonal cycle and contraceptive pill on cardiac and vascular function, as well as aerobic capacity among women. A well-structured study, minimizing confounding factors, will be conducted with repeated measurements at specific phases of the menstrual cycle to assess the influence of endogenous sexual hormone changes on cardiovascular function and aerobic capacity. The hypothesis is that cyclic changes in oestrogen and progesterone, and to a lesser extent hormonal contraception, could have a subtle but non-negligible influence on cardiovascular function at rest and during exercise.
To test this, 60 healthy young women (18-35 years old) (eumenorrheic, nulliparous, free of any gynaecological/cardiovascular/neurological/osteomuscular/respiratory pathologies, non-smokers, non-obese, not professional athletes), with (30 women) and without hormonal contraception (30 women), will undergo cardiovascular assessments at rest and during exercise (including HRV (heart rate variability) analysis at rest, during effort and after maximal effort, baroreflex and metaboreflex, echocardiography at rest and during effort, blood sample analysis for inflammatory and cardiovascular factors) at the following phases of one identical hormonal cycle: early follicular (menstruation), late follicular (ovulation), and mid-luteal phases.
Assessment of the menstrual phases (menstruation, late follicular phase (FP), and luteal phase (LP)) will be performed using three distinct approaches: monitoring cycle symptoms, daily urinary hormone concentration measurement, and blood hormone analysis during each visit.
详细描述
Recently, Caroline Criado Perez highlighted gender bias in her book "Invisible Women: Exposing Data Bias in a World Designed for Men". Perez sheds light on the pervasive bias against women, affecting various aspects of their lives in a world predominantly shaped by male-centric data. Town planning, public transport, car seat belt design, toilet facilities, pension policies, and smartphone tracking apps are among the areas revealing systemic disadvantages for women.
Moreover, women are also disadvantaged in terms of their own health. Menstrual cycle effects have been found for antipsychotics, antihistamines, antibiotics, and heart medications, meaning that dosages can sometimes be inappropriate. Sex differences in pharmacodynamics may also affect cardiovascular medications. This is not without consequences; for example, digoxin therapy is associated with an increase in all-cause mortality among women.
These issues persist because scientific studies dedicated to women are significantly under-represented in research. Sport science research is no exception. While women's sport is slowly but increasingly becoming accessible and popular worldwide, women remain under-represented in scientific studies on sports performance. This is illustrated by the fact that among three major Sports and Exercise Medicine journals, 1,382 articles involve a total of 6,076,580 participants, including 2,366,968 (39%) female participants and 3,709,612 (61%) male participants, with only 4-13% of the articles incorporating female participants exclusively. A primary justification for the lack of female inclusion in sports science research is the limited understanding of hormonal variations during the menstrual cycle.
The gap in female representation in sports science must be addressed. The present study aims to improve understanding of the impact of the hormonal cycle on sports performance among women with and without hormonal contraception. A deeper understanding of hormonal effects on performance may offer widespread benefits for women globally. The menstrual cycle is the sequence of hormonal and physiological changes that occur in a woman's body from the start of one period to the start of the next. Four main hormones regulate this sequence, dividing the cycle into three phases.
Hormonal fluctuations influence numerous physiological systems, and their effects during exercise may have implications for performance. Although several studies have observed performance variation between menstrual phases, others report no effects. At present, the literature lacks consensus, with conflicting results across studies. Due to methodological challenges and constraints, many studies are not sufficiently reliable to be conclusive.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, aged 18 to 35 years.
- •Healthy participant.
- •Current user of hormonal oral contraception for at least 3 months prior to enrollment; or
- •Naturally cycling woman not using hormonal contraception.
- •Regular menstrual cycles between 26 and 34 days, with no more than 2-3 days variation between consecutive cycles.
- •Evidence of ovulation during the menstrual cycle monitoring period.
- •Nulliparous.
- •Body mass index (BMI) between 18.5 and 25.0 kg/m².
- •Able and willing to comply with all study procedures and visits.
排除标准
- •Current smoker or use of nicotine-containing products.
- •Pregnancy or breastfeeding.
- •History or presence of gynecological disorders.
- •History or presence of cardiovascular disease.
- •History or presence of neurological disease.
- •History or presence of respiratory disease.
- •History or presence of musculoskeletal disorders that may affect exercise performance.
- •Obesity (BMI >25.0 kg/m²).
- •Use of medications known to affect cardiovascular, respiratory, autonomic, or hormonal function.
- •Inability or unwillingness to abstain from alcohol and caffeine for 72 hours before each experimental session.
研究组 & 干预措施
no hormonal contraception
Women with spontaneous regular natural cycles
under contraception - monophasic pill
Women taking monophasic contraceptive pill
结局指标
主要结局
Maximal Oxygen Uptake (VO₂max) Assessed by Cardiopulmonary Exercise Testing
时间窗: From enrollment to completion of study assessments (approximately 3 months, including 2 months of menstrual cycle and luteinizing hormone tracking followed by 1 month of laboratory visits).
Aerobic capacity will be assessed by maximal oxygen uptake (VO₂max) obtained during an incremental cardiopulmonary exercise test (CPET). VO₂max values will be compared across menstrual cycle phases and between naturally cycling women and women using hormonal contraception.
次要结局
- Right ventricular-pulmonary artery coupling across menstrual cycle phases and hormonal contraception assessed by echocardiography(From enrollment to completion of study assessments (approximately 3 months, including 2 months of menstrual cycle and luteinizing hormone tracking followed by 1 month of laboratory visits).)
- Resting Energy Expenditure Assessed by Indirect Calorimetry(From enrollment to completion of study assessments (approximately 3 months).)
- Spontaneous cardiac sensitivity at rest(From enrollment to completion of study assessments (approximately 3 months).)
- Cardiac baroreflex sensitivity during dynamic exercise(From enrollment to completion of study assessments (approximately 3 months).)
- Resting heart rate variability assessed by electrocardiography(From enrollment to completion of study assessments (approximately 3 months).)
- Anaerobic power assessed by the Wingate anaerobic test(From enrollment to completion of study assessments (approximately 3 months).)
研究者
Marine Carpentier
PT, MSc (HMS), PhD Student, Assistant
Université Libre de Bruxelles