Dose-Response Effects of Inspiratory Muscle Strength Training on Blood Pressure and Vascular Function
Systolic Hypertension · Brachial Artery Flow-mediated Dilation
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 144 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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).
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- No masking
15 Breaths/ Day
All sessions will be performed at 75% of each participant's PI max 7 days per week, for 6 weeks, using the POWERbreathe K5 device. Each session will take approximately 3-10 minutes depending on the assigned dose group.
Device: POWERbreathe K5
30 Breaths/ Day
All sessions will be performed at 75% of each participant's PI max 7 days per week, for 6 weeks, using the POWERbreathe K5 device. Each session will take approximately 3-10 minutes depending on the assigned dose group.
Device: POWERbreathe K5
45 Breaths/ Day
All sessions will be performed at 75% of each participant's PI max 7 days per week, for 6 weeks, using the POWERbreathe K5 device. Each session will take approximately 3-10 minutes depending on the assigned dose group.
Device: POWERbreathe K5
POWERbreathe K5 DEVICE
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.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Systolic Blood Pressure at 6 Weeks
Time frame: 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.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
University of MinnesotaMinneapolis, Minnesota, United StatesRecruiting
Study team and timeline
- Lead sponsor
- University of Minnesota
- Study start
- Oct 24, 2025 Actual
- Primary completion
- Mar 31, 2027 Estimated
- Study completion
- Mar 31, 2027 Estimated
- First posted
- Aug 7, 2025 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
Dose-Response Effects of Inspiratory Muscle Strength Training on Blood Pressure and Vascular Function
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Your message goes to WCR, including when this study is run by another organization. WCR may offer general guidance but may not operate this trial, have access to its team or be able to enroll you.
Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026
