Recruiting

Moderate Aerobic Exercise

Sponsor:

University of Colorado, Colorado Springs

Code:

NCT07084714

Conditions

Premenstrual Syndrome

Menstrual Cycle

Menstrual Distress (Dysmenorrhea)

Menstrual Bleeding, Heavy

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Not accepted

Interventions

Moderate Aerobic Exercise

Study Details

Brief 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.

Conditions

Premenstrual Syndrome

Menstrual Cycle

Menstrual Distress (Dysmenorrhea)

Menstrual Bleeding, Heavy

Study ID

NCT07084714

Start date

Jul, 2025

Status verified date

Jul, 2025

Completion date

Aug, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

35 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Non-hormonal contraceptive users

Women who report regular menstrual periods every 21-35 days and have not used hormonal or non-hormonal (i.e., intrauterine device) contraceptives in the past 6 months.

experimental: Hormonal contraceptive users

Women who are taking a combined oral contraceptive (i.e., those that contain a form of progesterone and estrogen) for at least the past 6 months.

Interventions

Moderate Aerobic Exercise

Participants will complete moderate intensity aerobic exercise for 30 minutes per session, progressing from three to five days per week to meet the minimum recommended aerobic physical activity guideline of 150 minutes per week set by the American College of Sports Medicine (ACSM) over two menstrual cycles. Moderate intensity is defined as maintaining a heart rate within 40-59% heart rate reserve and a rate of perceived exertion of 11-14 "light to somewhat hard" on the Borg 6-20 scale.

Primary outcome measure

  • Change from baseline in Menstrual Symptom Index (MSi) scores [ Time Frame: Baseline, 1 month, and 2 months ]
  • Change from baseline in Premenstrual Symptoms Screening Tool (PSST) - Symptoms [ Time Frame: Baseline, 1 month, 2 month ]
  • Change from baseline in Premenstrual Symptoms Screening Tool (PSST) - Quality of Life [ Time Frame: Baseline, 1 month, 2 months ]

Central Contacts and Locations

Central contacts

Marissa Baranauskas, PhD

719-255-4475mbaranau@uccs.edu

Locations

William J. Hybl Sports Medicine and Performance Center

Recruiting

Colorado Springs, Colorado, United States, 80918

More Information

Sponsor

University of Colorado, Colorado Springs

Last update posted

Jul 24, 2025

Last verified

Jul, 2025

Keywords

  • menstrual cycle
  • premenstrual syndrome
  • dysmenorrhea

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-12. This information was provided to ClinicalTrials.gov by University of Colorado, Colorado Springs on 2025-07-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.