Independent and Synergistic Effects of Physical and Psychosocial Stress on Functional Hypothalamic Amenorrhea in Exercising Women

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 35
Healthy Volunteers: t
View:

• 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)

Locations
United States
Colorado
University of Colorado Colorado Springs
RECRUITING
Colorado Springs
Contact Information
Primary
Marissa Baranauskas, PhD
mbaranau@uccs.edu
719-255-4475
Backup
Kristen Rudd, PhD
krudd@uccs.edu
Time Frame
Start Date: 2023-08-09
Estimated Completion Date: 2025-08-30
Participants
Target number of participants: 54
Treatments
No_intervention: Control
Participants will be asked to maintain their usual physical activity and lifestyle habits.
Experimental: Exercise Stress
The duration of participant's weekly running or cycling mileage will be increased by 30% while intensity is maintained.
Experimental: Psychosocial Stress
Participants will be asked to complete cognitive function tasks designed to be stressful while maintaining their usual physical activity habits.
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: University of Colorado, Colorado Springs

This content was sourced from clinicaltrials.gov