Impact of exercise and stress on menstrual cycle in female athletes
Independent and Synergistic Effects of Physical and Psychosocial Stress on Functional Hypothalamic Amenorrhea in Exercising Women
This study tests how exercise and stress affect the menstrual cycles of female athletes, like runners and cyclists, to see if they cause any irregularities.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | Female |
| Sponsor | University of Colorado, Colorado Springs Academic / other |
| Locations | 1 site (Colorado Springs, Colorado) |
| Trial ID | NCT05967819 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates how physical exercise and psychosocial stress affect menstrual cycle irregularities in female runners and cyclists. Participants will engage in structured exercise while monitoring their menstrual cycles, stress levels, and hormone levels over a three-month period. The study aims to determine the influence of these factors on reproductive hormones and menstrual cycle length, assessing both individual and combined effects of exercise and stress. Participants will undergo laboratory assessments and provide biological samples to support the research.
Who should consider this trial
Good fit: Ideal candidates are active women who engage in structured running or cycling exercises and have regular menstrual cycles.
Not a fit: Patients with a history of menstrual cycle disorders or metabolic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify effective strategies to manage menstrual cycle irregularities in female athletes.
How similar studies have performed: While there is ongoing research in this area, the specific combination of exercise and psychosocial stress on menstrual cycle regulation in this population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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
Where this trial is running
Colorado Springs, Colorado
- University of Colorado Colorado Springs — Colorado Springs, Colorado, United States (Recruiting)
Study contacts
- Study coordinator: Marissa Baranauskas, PhD
- Email: mbaranau@uccs.edu
- Phone: 719-255-4475
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.