Blood Pressure Measurement in Pregnancy, Hypertension Disorders in Pregnancy, Inspiratory Strength Training (IST), Pregnancy
Conditions
Keywords
pregnancy, blood pressure, hypertensive disorders of pregnancy, imst, hdp, inspiratory muscle strength training
Brief summary
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.
Interventions
OTHERExercise at 15% PI max
Minimal resistance training, similar to yoga, for 5 to 8 minutes a day over six weeks.
OTHERExercise at 50% PI max
Moderate resistance training, similar to strength training for 5 to 8 minutes a day over six weeks.
Sponsors
University of Arizona
Banner University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Female sex * Pregnant (32 to 34 weeks of gestation, confirmed by ultrasound, at the time of first training session, eligible patients may consent/enrolled earlier in pregnancy) * Singleton pregnancy * Age 18 to 55 * Able to read English and provide consent * Possess smartphone for syncing the AiroFit and Omron devices using Bluetooth and completing online surveys * Smartphone updated to iOS 12+ or Android 11+ * No contraindication for moderate exercise at time of enrollment * Not planning delivery for at least one month at time of enrollment (\< 38 weeks of gestation) * Willing to adhere to AiroFit device use throughout study period * Must already be scheduled, or in the process of scheduling, for weekly NST appointments by 32 to 34 weeks gestational age (per provider order / due to obstetric indication) Lower-Risk Pregnancy Cohort Inclusion Criteria: * No history or evidence of hypertensive disorders of pregnancy * May be undergoing antenatal testing for: * Conception via in vitro fertilization, BMI ≥ 35, an advanced maternal age (age \>/=35), or other condition not listed in
Exclusion criteria
or 'higher risk for HDP group' but is recommended for antenatal testing. Higher-Risk Pregnancy Cohort Inclusion Criteria: * Conditions associated with higher risk of developing HDP, including: * Gestational diabetes mellitus, chronic hypertension, gestational hypertension, or a history of preeclampsia in a previous pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Maternal and Fetal Safety Events During Inspiratory Muscle Strength Training (IMST) | 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. |
| Adherence to IMST Training and Home Blood Pressure (BP) Monitoring | 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. |
| Change from Baseline in Systolic Blood Pressure | 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. |
| Change from Baseline in Endothelial Function as Assessed by Post-Occlusive Reactive Hyperemia (PORH) | 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. |
| Change from Baseline in Urinary Nitrite/Nitrate Concentration | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Perceived Sleep Quality | 6 weeks | Change in self-reported sleep quality as measured by the PROMIS Sleep Disturbance short form, administered weekly via MyCap. |
| Change from Baseline in Dyspnea Severity | 6 weeks | Change in self-reported shortness of breath severity as measured by the PROMIS Dyspnea Severity items, administered weekly via MyCap. |
| Change from Baseline in Perceived Stress | 6 weeks | Change in perceived stress as measured by the Perceived Stress Scale (PSS), administered weekly via MyCap. |
Countries
United States
Contacts
CONTACTElise Erickson, PhD
CONTACTLily Woods, MA
Outcome results
None listed