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Breathing for Two: Inspiratory Muscle Strength Training for Supporting Healthy Blood Pressure in Pregnancy

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: t
View:

• 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

Locations
United States
Arizona
Banner University Medical Center
RECRUITING
Tucson
Contact Information
Primary
Elise Erickson, PhD
eliseerickson@arizona.edu
520-621-1139
Backup
Lily Woods, MA
lilywoods@arizona.edu
520-621-1139
Time Frame
Start Date: 2026-06-08
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 80
Treatments
Sham_comparator: Low-Resistance IMST
Active_comparator: Moderate-Resistance IMST
Related Therapeutic Areas
Sponsors
Collaborators: Banner University Medical Center
Leads: University of Arizona

This content was sourced from clinicaltrials.gov