William J. Hybl Sports Medicine and Performance Center
Colorado Springs, Colorado, 80918, United States
Location status: Recruiting
NCT Number: NCT07084714
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.
Interested in participating?
Request Info18 year–40 year
Female
Interventional
Not applicable
Colorado Springs, Colorado, 80918, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
Time frame: Baseline, month 1, month 2
mIU/mL
Time frame: Baseline, 1 month, 2 months
ug/mL
Time frame: Baseline, month 1, month 2
ng/mL
Contact information is provided by the study sponsor or research team.
University of Colorado, Colorado Springs
Other
Impact of Moderate Aerobic Exercise on Menstrual Cycle Symptoms in Sedentary Women
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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