Premenstrual SyndromeNCT07084714
Moderate Aerobic Exercise for Managing Menstrual Cycle Symptoms
A study testing Moderate Aerobic Exercise in people with Premenstrual Syndrome and Menstrual Cycle, run by University of Colorado, Colorado Springs at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Premenstrual Syndrome, Menstrual Cycle, Menstrual Distress (Dysmenorrhea)
- What is being tested?
- Moderate Aerobic Exercise
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2025to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
William J. Hybl Sports Medicine and Performance Center
Colorado Springs, Colorado, 80918
About this study
Official title: 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?
Read more
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
- Being tested
- Moderate Aerobic Exercise
- Keywords
- menstrual cycle, premenstrual syndrome, dysmenorrhea
- Medical subject headings
- Premenstrual Syndrome, Dysmenorrhea, Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate Aerobic ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Non-hormonal contraceptive users | Experimental | 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. Receives: Behavioral: Moderate Aerobic Exercise |
| Hormonal contraceptive users | Experimental | 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. Receives: Behavioral: Moderate Aerobic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Menstrual Symptom Index (MSi) scores
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.
Measured: Baseline, 1 month, and 2 months
Change from baseline in Premenstrual Symptoms Screening Tool (PSST) - Symptoms
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.
Measured: Baseline, 1 month, 2 month
Change from baseline in Premenstrual Symptoms Screening Tool (PSST) - Quality of Life
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.
Measured: Baseline, 1 month, 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study startJul 2025 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Colorado Springs
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marissa Baranauskas, University of Colorado, Colorado Springs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07084714
- Sponsor's protocol ID
- MOVE
- Status last verified
- Jul 2025
- First submitted
- 9 Jul 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Moderate Aerobic Exercise on Menstrual Cycle Symptoms in Sedentary Women
- ClinicalTrials.gov ID
- NCT07084714
- Acronym / sponsor ID
- MOVE
- Conditions
- Premenstrual Syndrome, Menstrual Cycle, Menstrual Distress (Dysmenorrhea), Menstrual Bleeding, Heavy
- Keywords
- menstrual cycle, premenstrual syndrome, dysmenorrhea
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University of Colorado, Colorado SpringsUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-hormonal contraceptive users | Experimental | Behavioral: Moderate Aerobic ExerciseWomen 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. |
| Hormonal contraceptive users | Experimental | Behavioral: Moderate Aerobic ExerciseWomen 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate Aerobic ExerciseParticipants 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. | Behavioural | Hormonal contraceptive users, Non-hormonal contraceptive users |
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate Aerobic Exercise in people with Premenstrual Syndrome and Menstrual Cycle, run by University of Colorado, Colorado Springs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marissa Baranauskas, PhD (719-255-4475, mbaranau@uccs.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Menstrual Symptom Index (MSi) scores (time frame: Baseline, 1 month, and 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.