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

Conditions

• Amenorrhea Secondary

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 35 Years

Healthy Volunteers

Accepted

Interventions

• Exercise Stress — BEHAVIORAL
  Increased exercise volume
• Psychosocial Stress — BEHAVIORAL
  cognitive tasks

Study Details

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.

Key Dates

Start date

Aug 9, 2023

Status verified

Jan 2026

Primary completion

Aug 30, 2026

Completion

Aug 30, 2026

Study Design

Enrollment

54 participants (estimated)

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

BASIC_SCIENCE

Arms

• 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.

Primary Outcome Measure

Urinary estrone-3-glucuronide (E3G) [ Time Frame: 3 months ]

Central Contacts

• Marissa Baranauskas, PhD
  719-255-4475
  [email protected]
• Kristen Rudd, PhD
  [email protected]

Locations (1)

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