BridgeMD
New treatment option for Premenstrual Syndrome
Official title Moderate Aerobic Exercise for Managing Menstrual Cycle Symptoms
ClinicalTrials.gov ID: NCT07084714
What this study is testing
- What it's testing
- 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?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40, women only
You may be able to join if
- 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...
- 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)
You likely can't join if
- 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...
- becoming pregnant during enrollment
- being diagnosed with a cardiovascular, metabolic, or renal disease that would require physical clearance to participate in moderate intensity aerobic...
- 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
See the full eligibility 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Colorado Springs, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Colorado Springs, Colorado, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.