RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: POWERbreathe K5 for Systolic Hypertension

This study will assess the dose-response effects of Inspiratory Muscle Strength Training (IMST) in adults with above-normal systolic blood pressure over a 6-week period.

Official registry: https://clinicaltrials.gov/study/NCT07109739 · University of Minnesota · enrollment listed as 144

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are POWERbreathe K5. The registry lists allocation as randomized. This study will assess the dose-response effects of Inspiratory Muscle Strength Training (IMST) in adults with above-normal systolic blood pressure over a 6-week period.

They plan to enroll about 144 people at Minneapolis. Taking part typically means using or being fitted with a device plus check-ins.

Official title (unrewritten)

Dose-Response Effects of Inspiratory Muscle Strength Training on Blood Pressure and Vascular Function

Interventions: POWERbreathe K5

Primary outcome (registry wording): Systolic Blood Pressure at 6 Weeks

Who it is for (from inclusion criteria)

Ages 18 Years to any
Resting SBP ≥120 mmHg as measured during screening 1 \& 2
Free from serious CV or metabolic diseases as identified by self-report and blood chemistry analysis
No contraindications to IMST (recent abdominal surgery, ruptured eardrum, asthma with very low symptom perception, fractured ribs, or pneumothorax)
Language: English-speaking, with ability to comprehend study materials and instructions
Lifestyle: Non-smokers (defined as self-report of not smoking cigarettes or vaping over the past year)

Who the registry excludes

Self-report of history of cardiovascular disease, or conditions affecting the ear (e.g., ruptured eardrum)
Recent abdominal surgery or presence of an abdominal hernia
Asthma with very low symptom perception, frequent severe exacerbations, or abnormally low perception of dyspnea
Ruptured eardrum or any other condition of the ear
Markedly elevated left ventricular end-diastolic volume and pressure
Current respiratory conditions such as a cold, sinusitis, or respiratory tract infection (participants may be included once they recover from the respiratory condition)
Female-Specific: Pregnant or planning to become pregnant during the study period

Public study contact (from the registry)

Olivia Ruhland

612-624-1588

ruhla064@umn.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

University of Minnesota — Minneapolis, Minnesota (recruiting)

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FAQ about this NCT record

Is NCT07109739 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07109739?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07109739?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary