Moderate Aerobic Exercise for Managing Menstrual Cycle Symptoms

July 17, 2025 updated by: Marissa Baranauskas, University of Colorado, Colorado Springs

Impact of Moderate Aerobic Exercise on Menstrual Cycle Symptoms in Sedentary Women

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Colorado
      • Colorado Springs, Colorado, United States, 80918
        • Recruiting
        • William J. Hybl Sports Medicine and Performance Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: 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.
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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Menstrual Symptom Index (MSi) scores
Time Frame: Baseline, 1 month, and 2 months
The MSi asks participants to report the intensity they are experiencing 18 menstrual related symptoms on a scale ranging from 0 = "do not feel at all" to 3 = "intense." A score of 0 indicates no symptom burden and 54 the maximum symptom burden.
Baseline, 1 month, and 2 months
Change from baseline in Premenstrual Symptoms Screening Tool (PSST) - Symptoms
Time Frame: Baseline, 1 month, 2 month
The PSST has participants report the intensity which they experience 14 premenstrual symptoms on a scale ranging from 0 = "not at all" to 3 = "intense". A score of 0 reflects no premenstrual symptom burden and a score of 42 indicates maximal premenstrual symptom burden.
Baseline, 1 month, 2 month
Change from baseline in Premenstrual Symptoms Screening Tool (PSST) - Quality of Life
Time Frame: Baseline, 1 month, 2 months
The PSST asks participants to report the severity by which premenstrual symptoms affect 4 functional aspects of life related to work, relationships with coworkers and family, and home responsibilities on a scale ranging from 0 = "not at all" to 3 = "severe". A score of 0 indicates no interference and 12 maximal interference.
Baseline, 1 month, 2 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary luteinizing hormone (LH)
Time Frame: Baseline, month 1, month 2
mIU/mL
Baseline, month 1, month 2
Urinary pregnanediol glucuronide (PdG)
Time Frame: Baseline, 1 month, 2 months
ug/mL
Baseline, 1 month, 2 months
Urinary estrone-3-glucuronide (E3G)
Time Frame: Baseline, month 1, month 2
ng/mL
Baseline, month 1, month 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Colorado Springs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

July 9, 2025

First Submitted That Met QC Criteria

July 17, 2025

First Posted (Actual)

July 24, 2025

Study Record Updates

Last Update Posted (Actual)

July 24, 2025

Last Update Submitted That Met QC Criteria

July 17, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOVE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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