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

1. juli 2026 opdateret af: Elise Erickson, University of Arizona
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.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

80

Fase

  • Tidlig fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

    • Arizona
      • Tucson, Arizona, Forenede Stater, 85719
        • Rekruttering
        • Banner University Medical Center
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Sham-komparator: Low-Resistance IMST
Minimal resistance training, similar to yoga, for 5 to 8 minutes a day over six weeks.
Aktiv komparator: Moderate-Resistance IMST
Moderate resistance training, similar to strength training for 5 to 8 minutes a day over six weeks.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of Maternal and Fetal Safety Events During Inspiratory Muscle Strength Training (IMST)
Tidsramme: 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.
6 weeks
Adherence to IMST Training and Home Blood Pressure (BP) Monitoring
Tidsramme: 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.
6 weeks
Change from Baseline in Systolic Blood Pressure
Tidsramme: 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.
6 weeks
Change from Baseline in Endothelial Function as Assessed by Post-Occlusive Reactive Hyperemia (PORH)
Tidsramme: 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.
6 weeks
Change from Baseline in Urinary Nitrite/Nitrate Concentration
Tidsramme: 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
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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from Baseline in Perceived Sleep Quality
Tidsramme: 6 weeks
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
Tidsramme: 6 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
Tidsramme: 6 weeks
Change in perceived stress as measured by the Perceived Stress Scale (PSS), administered weekly via MyCap.
6 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

8. juni 2026

Primær færdiggørelse (Anslået)

30. juni 2027

Studieafslutning (Anslået)

30. september 2027

Datoer for studieregistrering

Først indsendt

8. juni 2026

Først indsendt, der opfyldte QC-kriterier

1. juli 2026

Først opslået (Faktiske)

7. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

All IPD that underlie results in a publication will be shared, after any identifying information is removed from the dataset.

IPD-delingstidsramme

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).

IPD-delingsadgangskriterier

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.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ja

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Kliniske forsøg med Graviditet

  • King's College Hospital NHS Trust
    European Association for the Study of the Liver
    Rekruttering
    Cirrhose, lever | HELLP syndrom | Intrahepatisk kolestase af graviditet | Graviditetssygdom | AFLP - Acute Fatty Lever of Pregnancy
    Det Forenede Kongerige

Kliniske forsøg med Exercise at 15% PI max

3
Abonner