Brachial Artery Flow-mediated Dilation, Systolic Hypertension
Conditions
Brief 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.
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.
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic Blood Pressure at 6 Weeks | Week 6 | To determine resting SBP before and after 6 weeks of IMST 15, IMST 30, or IMST 45 (75% PI max for all groups) in men and women aged ≥18 years with resting SBP ≥120 mmHg. |
Countries
United States
Contacts
Primary ContactHannah Westerberg
Outcome results
None listed