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| Name | Class |
|---|---|
| Banner University Medical Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-Resistance IMST | Sham Comparator |
| |
| Moderate-Resistance IMST | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise at 15% PI max | Other | Minimal resistance training, similar to yoga, for 5 to 8 minutes a day over six weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Maternal and Fetal Safety Events During Inspiratory Muscle Strength Training (IMST) | 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. | 6 weeks |
| Adherence to IMST Training and Home Blood Pressure (BP) Monitoring | 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. | 6 weeks |
| Change from Baseline in Systolic Blood Pressure | Change in systolic BP (mmHg), measured via validated automated oscillometric sphygmomanometer (Omron BP7450) per ESH-IP protocol, comparing IMST and sham IMST groups. | 6 weeks |
| Change from Baseline in Endothelial Function as Assessed by Post-Occlusive Reactive Hyperemia (PORH) | 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. | 6 weeks |
| Change from Baseline in Urinary Nitrite/Nitrate Concentration | 6 weeks | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Perceived Sleep Quality | Change in self-reported sleep quality as measured by the PROMIS Sleep Disturbance short form, administered weekly via MyCap. | 6 weeks |
| Change from Baseline in Dyspnea Severity |
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Inclusion Criteria:
Lower-Risk Pregnancy Cohort Inclusion Criteria:
Higher-Risk Pregnancy Cohort Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elise Erickson, PhD | Contact | 520-621-1139 | eliseerickson@arizona.edu | |
| Lily Woods, MA | Contact | 520-621-1139 | lilywoods@arizona.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University Medical Center | Recruiting | Tucson | Arizona | 85719 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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All IPD that underlie results in a publication will be shared, after any identifying information is removed from the dataset.
Upon publication, for a period of 2 years, the IPD will be available using a publicly available repository/storage system (e.g. Open Science Framework or similar).
Any data that is made publicly available can be accessed without permission/restriction. Beyond the initial 2 year period, data can be made available upon reasonable request to the PI.
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| Exercise at 50% PI max | Other | Moderate resistance training, similar to strength training for 5 to 8 minutes a day over six weeks. |
|
Change in self-reported shortness of breath severity as measured by the PROMIS Dyspnea Severity items, administered weekly via MyCap.
| 6 weeks |
| Change from Baseline in Perceived Stress | Change in perceived stress as measured by the Perceived Stress Scale (PSS), administered weekly via MyCap. | 6 weeks |