Independent and Synergistic Effects of Physical and Psychosocial Stress on Functional Hypothalamic Amenorrhea in Exercising Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Urinary luteinizing hormone (LH)
研究概览
简要总结
The goal of this clinical trial is to determine how changes in exercise and psychosocial stress may influence the risk of menstrual cycle irregularities in female runners and cyclists. The main questions it aims to answer are:
- Does the implementation of exercise or psychosocial stress effect circulating reproductive hormones (i.e., estradiol, progesterone, luteinizing hormone) and menstrual cycle length?
- Is there an additive effect of combined exercise and psychosocial on circulating reproductive hormones (i.e., estradiol, progesterone, luteinizing hormone) and menstrual cycle length?
Participants will be asked to do the following over the ~3 month enrollment period:
- attend a laboratory visit at the beginning and end of the study to have their resting metabolic rate, aerobic fitness, and body composition tested
- monitor their menstrual cycle length, daily perceived stress levels, physical activity, and diet each month
- provide several urine and saliva samples each month
- either maintain their usual physical activity and lifestyle habits (control group), increase the duration of their weekly running or cycling mileage by 30% (exercise stress group), complete cognitive function tasks designed to be stressful (psychosocial stress group), or increase the duration of their weekly running or cycling mileage by 30% and complete cognitive function tasks designed to be stressful (exercise + psychosocial stress group) during the final month of enrollment.
Researchers will compare control, exercise stress, psychosocial stress, and exercise + psychosocial stress groups to see if there is an effect on circulating reproductive hormones (i.e., estradiol, progesterone, luteinizing hormone) and menstrual cycle length.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •participates in structured running or cycling exercise for at least 30 minutes on 4 days per week or more
- •have regular periods every 21 to 35 days
- •have not used hormonal contraceptives for at least the past 6 months
- •are not currently or trying to become pregnant or are breastfeeding, and have not been pregnant or breastfeeding for the past 12 months
- •have never been diagnosed with a menstrual cycle disorder (e.g., menorrhagia, amenorrhea, dysmenorrhea, polycystic ovary syndrome [PCOS], endometriosis, premenstrual dysphoric disorder [PMDD], menstrual migraines, ovarian cancer, ovarian insufficiency, uterine or endometrial cancer)
- •have never been diagnosed with a metabolic disease (e.g., hypothyroidism, hyperthyroidism, Cushing disease, Addison's disease, diabetes)
排除标准
- •missing > 4 consecutive days of aerobic exercise (i.e., running, cycling, cross training) if assigned to the exercise intervention groups
- •they indicate they "Could not participate at all due to a health problem" or have had to modify their exercise training, felt their injury, illness, or other health problem has affected their exercise performance, or experienced symptoms/ health complaints greater than "To a minor extent" on the Oslo Sports Trauma Research Center Questionnaire (exercise training intervention group)
- •demonstrate clinical low energy availability as defined as energy availability <30 Kcal/kg fat free mass in the first two months of at-home monitoring
- •report menstrual cycle lengths <21 days or >35 days in the first two months of at-home monitoring
- •do not demonstrate an anticipated rise in progesterone levels during the latter half of their cycle and luteinizing hormone levels at mid-cycle compared to tests taken during the first few days after menses in the first two months of at-home monitoring
- •begin taking a hormonal contraceptive
- •become pregnant
- •are diagnosed with a menstrual cycle disorder (e.g., menorrhagia, amenorrhea, dysmenorrhea, polycystic ovary syndrome [PCOS], endometriosis, premenstrual dysphoric disorder [PMDD], menstrual migraines, ovarian cancer, ovarian insufficiency, uterine or endometrial cancer)
- •are diagnosed with a metabolic disease (e.g., hypothyroidism, hyperthyroidism, Cushing disease, Addison's disease, diabetes), 10) are diagnosed with a major cardiovascular disease, respiratory disease, or musculoskeletal injury
- •are unable to follow instructions for any of the procedures
研究组 & 干预措施
Exercise Stress
The duration of participant's weekly running or cycling mileage will be increased by 30% while intensity is maintained.
干预措施: Exercise Stress (Behavioral)
Control
Participants will be asked to maintain their usual physical activity and lifestyle habits.
Psychosocial Stress
Participants will be asked to complete cognitive function tasks designed to be stressful while maintaining their usual physical activity habits.
干预措施: Psychosocial Stress (Behavioral)
Exercise + Psychosocial Stress
Participants will be asked to complete cognitive function tasks designed to be stressful while the duration of their weekly running or cycling mileage is increased by 30% and intensity maintained.
干预措施: Exercise Stress (Behavioral)
Exercise + Psychosocial Stress
Participants will be asked to complete cognitive function tasks designed to be stressful while the duration of their weekly running or cycling mileage is increased by 30% and intensity maintained.
干预措施: Psychosocial Stress (Behavioral)
结局指标
主要结局
Urinary luteinizing hormone (LH)
时间窗: 3 months
MIU/mL
Menstrual cycle length
时间窗: 3 months
days
Urinary pregnanediol glucuronide (PdG)
时间窗: 3 months
ug/mL
Urinary estrone-3-glucuronide (E3G)
时间窗: 3 months
ng/mL
次要结局
未报告次要终点
研究者
Marissa Baranauskas
Assistant Professor
University of Colorado, Colorado Springs