How different doses of inspiratory muscle strength training affect blood pressure and blood vessel function
Dose-Response Effects of Inspiratory Muscle Strength Training on Blood Pressure and Vascular Function
NA · University of Minnesota · NCT07109739
This 6-week test sees if different amounts of inspiratory muscle strength training lower systolic blood pressure and improve blood vessel function in adults with above-normal systolic blood pressure.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Minnesota (other) |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT07109739 on ClinicalTrials.gov |
What this trial studies
Adults with resting systolic blood pressure of 120 mmHg or higher will complete 6 weeks of inspiratory muscle strength training (IMST) using the POWERbreathe K5 device at varying training doses. Resting systolic blood pressure and brachial artery flow-mediated dilation will be measured before and after the training period to examine dose-related responses. Participants must be at least 18 years old, non-smokers, English-speaking, and free of serious cardiovascular or metabolic disease and other contraindications to IMST. The protocol includes standardized pre-visit restrictions on food, caffeine, exercise, alcohol, and non-prescribed medications to ensure consistent measurement conditions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older with resting systolic blood pressure ≥120 mmHg who are non-smokers, English-speaking, and have no serious cardiovascular or metabolic disease or contraindications to IMST.
Not a fit: People with established cardiovascular disease, recent abdominal surgery, ear conditions such as a ruptured eardrum, asthma with very low symptom perception, smokers, or those unable to attend in-person visits are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, IMST could provide a non-drug way to lower systolic blood pressure and improve arterial health.
How similar studies have performed: Prior small clinical studies have shown that IMST can reduce blood pressure and improve vascular measures, but dose-response data over a 6-week period are limited.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (RECRUITING)
Study contacts
- Principal investigator: Daniel Craighead, PhD — University of Minnesota
- Study coordinator: Hannah Westerberg
- Email: lewi1241@umn.edu
- Phone: 612-624-1588
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Systolic Hypertension, Brachial Artery Flow-mediated Dilation