Moderate aerobic exercise to manage menstrual symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will enroll premenopausal, sedentary women who report menstrual symptoms and either have used combined oral contraceptives for at least six months or have not used hormonal contraception for at least six months. Participants will follow a moderate aerobic exercise intervention while reporting daily symptoms using the Menstrual Symptom Index, and body composition will be measured by DXA before and after the program. The study compares changes in physical and psychological symptom burden between hormonal contraceptive users and non-users to determine if contraceptive status modifies the effect of exercise. Primary outcomes include symptom score changes and body composition shifts associated with the intervention.

Why it matters

Who can join: the full rules

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 different type of contraceptive or discontinue combined hormonal contraceptive use if assigned to the hormonal contraceptive arm

Where it's running

• William J. Hybl Sports Medicine and Performance Center
  Colorado Springs, Colorado, United States Recruiting

Study contacts

• Study coordinator: Marissa Baranauskas, PhD
• Email: mbaranau@uccs.edu
• Phone: 719-255-4475

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.