Recruiting
Dose-Response Effects of Inspiratory Muscle Strength Training on Blood Pressure and Vascular Function
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.
ClinicalTrials.gov IDNCT07109739
PhaseNA
Enrollment144
SponsorUniversity of Minnesota
Age18 Years and older
SexALL
Conditions studied
Systolic Hypertension, Brachial Artery Flow-mediated Dilation
About this study
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.
Interventions
- Device: POWERbreathe 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.
Primary outcomes
- Systolic Blood Pressure at 6 Weeks (Week 6)
Eligibility information
Inclusion Criteria:
* 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 Criteria:
* 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).
Study locations
- University of Minnesota, Minneapolis, Minnesota 55455 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-11-13.