RecruitingNot Applicable

Moderate Aerobic Exercise for Managing Menstrual Cycle Symptoms

United States35 participantsStarted 2025-07

Plain-language summary

The goal of this clinical trial is to evaluate the impact of moderate aerobic exercise on menstrual symptom management in sedentary women both using and not using hormonal contraceptives. The main questions it aims to answer are: Is there a reduction in physical and/or psychological menstrual cycle related symptom burden with participation in moderate aerobic exercise for sedentary women using and not using hormonal contraceptives? Is there a difference in physical and/or psychological menstrual cycle related symptom burden between hormonal contraceptive and non-hormonal contraceptive users? Is a moderate aerobic exercise intervention more effective in reducing physical and/or psychological menstrual related symptom burden for sedentary women using or not using hormonal contraceptives? Participants will: * Have their body composition assessed using dual energy X-ray absorptiometry pre and post exercise intervention. * Complete a Menstrual Symptom Index (MSi) to report daily menstrual cycle related symptom burden in addition to the Premenstrual Symptom Screening Tool (PSST) and Heavy Menstrual Bleeding (HMB) questionnaire monthly. * Utilize an at-home monitor to test urinary luteinizing hormone, estrone-3-glucuronide, and pregnanediol glucuronide approximately 10 times per month and report menstrual cycle length. * Record physical activity habits by continuously wearing a wrist-based accelerometer and chest-strap heart rate monitor during planned aerobic exercise sessions and complete the International Physical Activity Questionnaire (IPAQ) monthly. * Maintain their usual sedentary activity habits for one menstrual cycle followed by completion of an exercise intervention designed to progress individuals to meet minimum recommended aerobic physical activity guidelines of 150 minutes per week set by the American College of Sports Medicine for two menstrual cycles.

Who can participate

Age range

18 Years – 40 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * premenopausal (defined as having regular menstrual periods every 21-35 days) * either not using hormonal or non-hormonal contraceptives (i.e., intrauterine device) for the past 6 months OR using combined oral contraceptives (i.e., those that contain progesterone and estrogen) for at least the past 6 months * not currently pregnant or trying to become pregnant * sedentary lifestyle (score of "low activity/inactive" assessed using the IPAQ) * have self reported menstrual cycle symptoms (symptoms reported on the PSST or MSi) * do not have a medical diagnosis or signs/symptoms of diabetes, cardiovascular, or renal disease and are able to participate in moderate intensity physical activity without physician clearance Exclusion Criteria: * becoming physically active defined as scoring higher than "low activity/inactive" on the IPAQ during the first month of the study * non compliance with instructions provided for the moderate aerobic exercise intervention (i.e., not adhering to predetermined intensity heart rate targets) or miss more than 25% of exercise sessions in either intervention month * becoming pregnant during enrollment * being diagnosed with a cardiovascular, metabolic, or renal disease that would require physical clearance to participate in moderate intensity aerobic physical activity * begin using hormonal or non-hormonal (i.e., intrauterine devices) contraceptives if assigned to the arm not using hormonal contraceptives * either begin a differ…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from baseline in Menstrual Symptom Index (MSi) scores

Timeframe: Baseline, 1 month, and 2 months

Change from baseline in Premenstrual Symptoms Screening Tool (PSST) - Symptoms

Timeframe: Baseline, 1 month, 2 month

Change from baseline in Premenstrual Symptoms Screening Tool (PSST) - Quality of Life

Timeframe: Baseline, 1 month, 2 months

Trial details

NCT IDNCT07084714

SponsorUniversity of Colorado, Colorado Springs

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08

Contact for this trial

Marissa Baranauskas, PhD

719-255-4475 mbaranau@uccs.edu

View on ClinicalTrials.gov More Premenstrual Syndrome trials