Banner University Medical Center
Tucson, Arizona, 85719, United States
Location status: Recruiting
NCT Number: NCT07687745
This is an interventional study that will test whether a breathing exercise called Inspiratory Muscle Strength Training (IMST) can safely and effectively lower blood pressure during late pregnancy. The goal is to see if a home-based breathing training can help prevent or reduce high blood pressure disorders in pregnancy. The main objectives are to make sure the training is safe and tolerable for pregnant women and to examine blood pressure and blood vessel health. Participants in their third trimester will be randomly assigned to either do moderate resistance IMST or a minimal resistance sham IMST, for 5 to 8 minutes a day over six weeks.
Interested in participating?
Request Info18 year–55 year
Female
Interventional
Early Phase 1
Tucson, Arizona, 85719, United States
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Lower-Risk Pregnancy Cohort Inclusion Criteria:
Higher-Risk Pregnancy Cohort Inclusion Criteria:
Exclusion criteria
Minimal resistance training, similar to yoga, for 5 to 8 minutes a day over six weeks.
Moderate resistance training, similar to strength training for 5 to 8 minutes a day over six weeks.
Time frame: 6 weeks
Percentage of training sessions associated with abnormal post-training fetal heart rate (FHR) tracing, or with maternal oxygen desaturation (SpO2) or symptoms (e.g., perceived exertion, lightheadedness, hyperventilation), as assessed by study staff during non-stress test (NST) and clinic visits.
Time frame: 6 weeks
Percentage of prescribed daily IMST training sessions and daily home BP measurements completed by each participant, as captured via training device data and MyCap entries.
Time frame: 6 weeks
Change in systolic BP (mmHg), measured via validated automated oscillometric sphygmomanometer (Omron BP7450) per ESH-IP protocol, comparing IMST and sham IMST groups.
Time frame: 6 weeks
Change in cutaneous microvascular blood flow response (perfusion units) following brief arterial occlusion, measured via Laser Doppler Blood FlowMetry, comparing IMST and sham IMST groups.
Time frame: Change in urinary nitrite/nitrate concentration (µM), measured weekly via Griess colorimetric assay (Cayman Nitrite Colorimetric Assay), as an indirect marker of nitric oxide bioavailability.
6 weeks
Time frame: 6 weeks
Change in self-reported sleep quality as measured by the PROMIS Sleep Disturbance short form, administered weekly via MyCap.
Time frame: 6 weeks
Change in self-reported shortness of breath severity as measured by the PROMIS Dyspnea Severity items, administered weekly via MyCap.
Time frame: 6 weeks
Change in perceived stress as measured by the Perceived Stress Scale (PSS), administered weekly via MyCap.
Contact information is provided by the study sponsor or research team.
Elise Erickson, PhD
CONTACT
Lily Woods, MA
CONTACT
University of Arizona
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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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