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

NCT07109739 · University of Minnesota
In plain English

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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.
Eligibility criteria
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 design
Enrollment target: 144 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-10-24
Estimated completion: 2027-03-31
Last updated: 2025-11-25
Interventions
Device: POWERbreathe K5
Primary outcomes
  • Systolic Blood Pressure at 6 Weeks (Week 6)
Sponsor
University of Minnesota · other
Contacts & investigators
ContactHannah Westerberg · contact · lewi1241@umn.edu · 612-624-1588
InvestigatorDaniel Craighead, PhD · principal_investigator, University of Minnesota
All locations (1)
University of MinnesotaRecruiting
Minneapolis, Minnesota, United States
Dose-Response Effects of Inspiratory Muscle Strength Training on Blood Pressure and Vascular Function · TrialPath