Physical and Psychosocial Stress for Amenorrhea
(FHA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how exercise and stress affect menstrual cycles in female runners and cyclists. It aims to determine if increased exercise or stress alters hormone levels and cycle length, and whether their combination has a greater impact. Participants will either maintain their usual routines or increase exercise (exercise stress) and stress levels (psychosocial stress) to observe the effects. Ideal candidates are women who regularly run or cycle and have consistent menstrual cycles. As an unphased trial, this study provides a unique opportunity to contribute to understanding the interplay between exercise, stress, and menstrual health.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, you must not have used hormonal contraceptives for at least the past 6 months and should not begin taking them during the trial.
What prior data suggests that these stress protocols are safe for participants?
Research has shown that exercise can affect menstrual cycles in some women. About 5% to 20% of women who exercise extensively may experience exercise-induced amenorrhea, where periods become irregular or stop. This condition is more common among elite athletes, such as runners, affecting up to 40% to 50%. It's important to note that effects can vary from person to person.
Studies have also shown that stress can impact menstrual cycles. Higher stress levels have been linked to issues like irregular periods and infertility. Stress can alter hormone levels, affecting the menstrual cycle.
When exercise and stress combine, the effects might intensify. Some research suggests that up to 80% of women who exercise vigorously could experience menstrual problems. However, the exact effects depend on individual factors, such as stress levels and exercise intensity.
Overall, while these factors can influence menstrual health, the specific impact varies for each person. Researchers closely monitor study participants to ensure their safety and well-being.12345Why are researchers excited about this trial?
Researchers are excited about exploring stress as a treatment for amenorrhea because it shifts the focus from traditional medical interventions, like hormonal therapies, to lifestyle-based approaches. The trial examines both exercise stress and psychosocial stress, which could offer a more holistic way to manage this condition. By increasing physical activity levels and using cognitive tasks to stimulate stress, these methods could potentially regulate menstrual cycles naturally. This approach might appeal to those seeking non-pharmacological options and could also provide insights into the broader effects of stress on the body.
What evidence suggests that this trial's treatments could be effective for amenorrhea?
Research has shown that both exercise and stress affect menstrual cycles. Intense exercise is linked to menstrual issues, with up to 80% of active women experiencing some form of menstrual problem. Similarly, studies have indicated that stress often connects to irregular periods and other reproductive health concerns. This trial will explore these effects through different treatment arms. Participants in the Exercise Stress arm will increase their weekly running or cycling mileage by 30%. Those in the Psychosocial Stress arm will complete cognitive tasks designed to be stressful. Another group will experience both Exercise and Psychosocial Stress combined. These findings suggest that changes in exercise and stress levels can significantly impact hormones and menstrual regularity.12367
Are You a Good Fit for This Trial?
This trial is for female runners and cyclists who can complete a 5-km race in under 25 minutes, have regular menstrual cycles every 21 to 35 days, haven't used hormonal contraceptives or been pregnant/breastfeeding for the past six months, exercise regularly, and don't have metabolic diseases or menstrual disorders.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants attend a laboratory visit to have their resting metabolic rate, aerobic fitness, and body composition tested
Intervention
Participants either maintain their usual physical activity and lifestyle habits, increase their weekly running or cycling mileage by 30%, complete cognitive function tasks designed to be stressful, or both
Follow-up
Participants are monitored for changes in menstrual cycle length and reproductive hormones
What Are the Treatments Tested in This Trial?
Interventions
- Exercise Stress
- Psychosocial Stress
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Colorado Springs
Lead Sponsor