- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07687745
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
Status
Rekruttering
Betingelser
Intervention / Behandling
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
- Navn: Elise Erickson, PhD
- Telefonnummer: 520-621-1139
- E-mail: eliseerickson@arizona.edu
Undersøgelse Kontakt Backup
- Navn: Lily Woods, MA
- Telefonnummer: 520-621-1139
- E-mail: lilywoods@arizona.edu
Studiesteder
-
-
Arizona
-
Tucson, Arizona, Forenede Stater, 85719
- Rekruttering
- Banner University Medical Center
-
Kontakt:
- Rachel Darche, MD
- Telefonnummer: 520-621-1139
- E-mail: rldarche@arizona.edu
-
-
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.
Sponsor
Samarbejdspartnere
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
Nøgleord
Andre undersøgelses-id-numre
- STUDY00007216
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
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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