Recruiting

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

Sponsor:

University of Minnesota

Code:

NCT07109739

Conditions

Systolic Hypertension

Brachial Artery Flow-mediated Dilation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

POWERbreathe K5

Study Details

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.

Conditions

Systolic Hypertension

Brachial Artery Flow-mediated Dilation

Study ID

NCT07109739

Start date

Oct 24, 2025

Status verified date

Nov, 2025

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

144 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 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.

active comparator: 30 Breaths/ Day

active comparator: 45 Breaths/ Day

Interventions

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 outcome measure

Systolic Blood Pressure at 6 Weeks [ Time Frame: Week 6 ]

Central Contacts and Locations

Central contacts

Hannah Westerberg

612-624-1588 lewi1241@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Hannah Westerberg

612-624-1588 lewi1241@umn.edu

More Information

Sponsor

University of Minnesota

Last update posted

Nov 25, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2025-11-25.