RecruitingNot ApplicableNCT07109739
Dose-Response Effects of Inspiratory Muscle Strength Training on Blood Pressure and Vascular Function
Sponsor
University of Minnesota
Enrollment
144 participants
Start Date
Oct 24, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria7
- Age ≥18 years
- 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.
- Pre-visit Compliance: Willing to comply with pre-visit instructions (avoiding food and caffeine ≥ 3 hours, vigorous exercise, alcohol, and non-prescribed medications ≥ 24 hours) prior to each measurement visit.
- Lifestyle: Non-smokers (defined as self-report of not smoking cigarettes or vaping over the past year).
Exclusion Criteria8
- 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.
- Compliance: Unable or unwilling to comply with pre-visit restrictions (e.g., avoiding caffeine, alcohol, and exercise within specified hours before visits).
Interventions
DEVICEPOWERbreathe K5
The POWERbreathe K5 is portable, battery-powered, and commercially available. No modifications to the FDA-approved design are being made. Its use in this study is consistent with prior published human research and does not constitute a significant deviation from labeled use in terms of safety or function.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07109739