Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07687745

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Banner University Medical Center

Tucson, Arizona, 85719, United States

Location status: Recruiting

Location contact

Rachel Darche, MD

CONTACT

[email protected]

520-621-1139

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

  • Younger than 18 or older than 55 years of age
  • Multiple gestation (twin or higher-order pregnancy)
  • Fetal chromosomal abnormalities or major anatomical anomalies
  • Planning to deliver earlier than 38 weeks or within 4 weeks of study enrollment
  • Any contraindication for moderate exercise (e.g., cardiomyopathy, congenital cardiac conditions)
  • Deep vein thrombosis
  • Complications in current pregnancy including intrauterine growth restriction (IUGR), oligohydramnios, preeclampsia, or severe-range blood pressures (>/=160/110 or <100/60)
  • Active vaginal bleeding, or history of coagulopathy
  • Placenta previa or other placental abnormalities (including placental cyst or abruption)
  • Signs of labor
  • Current substance use disorder
  • History of neurological, respiratory, head/neck, or thoracic surgeries, or conditions such as collapsed lung or perforated eardrum
  • Individuals with any of the following:
  • Chronic obstructive pulmonary disorder (COPD)
  • Severe asthma
  • Severe ischemic heart disease
  • Left-sided heart failure
  • Chronic laryngitis, chronic bronchitis, emphysema, pneumonia
  • Latent or active tuberculosis
  • Chronic cough
  • Neurological problems (e.g. seizure disorder)
  • Severe scoliosis with no history of surgical correction or management.
  • Organ transplant
  • HIV or other immunocompromising conditions
  • Autoimmune disease with possible vascular complications (e.g. Lupus)
  • Significant respiratory compromise (e.g., severe dyspnea, O₂ saturation <95%, uncontrolled asthma, history of pneumothorax)

Treatment and study plan

Exercise at 15% PI max

Other

Minimal resistance training, similar to yoga, for 5 to 8 minutes a day over six weeks.

Exercise at 50% PI max

Other

Moderate resistance training, similar to strength training for 5 to 8 minutes a day over six weeks.

Primary outcomes

  1. Incidence of Maternal and Fetal Safety Events During Inspiratory Muscle Strength Training (IMST)

    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.

  2. Adherence to IMST Training and Home Blood Pressure (BP) Monitoring

    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.

  3. Change from Baseline in Systolic Blood Pressure

    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.

  4. Change from Baseline in Endothelial Function as Assessed by Post-Occlusive Reactive Hyperemia (PORH)

    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.

  5. Change from Baseline in Urinary Nitrite/Nitrate Concentration

    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

Secondary outcomes

  1. Change from Baseline in Perceived Sleep Quality

    Time frame: 6 weeks

    Change in self-reported sleep quality as measured by the PROMIS Sleep Disturbance short form, administered weekly via MyCap.

  2. Change from Baseline in Dyspnea Severity

    Time frame: 6 weeks

    Change in self-reported shortness of breath severity as measured by the PROMIS Dyspnea Severity items, administered weekly via MyCap.

  3. Change from Baseline in Perceived Stress

    Time frame: 6 weeks

    Change in perceived stress as measured by the Perceived Stress Scale (PSS), administered weekly via MyCap.

Study contacts

Contact information is provided by the study sponsor or research team.

Elise Erickson, PhD

CONTACT

[email protected]

520-621-1139

Lily Woods, MA

CONTACT

[email protected]

520-621-1139

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Collaborators

  • Banner University Medical Center

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 7, 2026
Registry last updated
Jul 7, 2026

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.

Published trials that share one or more normalized conditions with this study.