RECRUITING

Moderate Aerobic Exercise for Managing Menstrual Cycle Symptoms

Conditions

Premenstrual Syndrome Menstrual Cycle Menstrual Distress (Dysmenorrhea)Menstrual Bleeding, Heavy dysmenorrhea

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-07

Study Completion:2026-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07084714

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.

Ages Eligible for Study:18 Years to 40 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Marissa Baranauskas, PhD

CONTACT

719-255-4475

mbaranau@uccs.edu

Study Locations (Sites)

William J. Hybl Sports Medicine and Performance Center

Colorado Springs, Colorado, 80918

United States

Collaborators and Investigators

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 Registration Dates

Study Start Date2025-07

Study Completion Date2026-08

Study Record Updates

Study Start Date2025-07

Study Completion Date2026-08

Terms related to this study

Keywords Provided by Researchers

menstrual cycle
premenstrual syndrome
dysmenorrhea

Additional Relevant MeSH Terms

Premenstrual Syndrome
Menstrual Cycle
Menstrual Distress (Dysmenorrhea)
Menstrual Bleeding, Heavy