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RecruitingNCT07109739ClinicalTrials.gov record

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

Systolic Hypertension · Brachial Artery Flow-mediated Dilation

THE QUICK READ

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).
Understand screening

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.

Prepare your questions

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.

No results are flagged as posted.

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

Olivia RuhlandCONTACTruhla064@umn.edu612-624-1588
Official study title

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

A HUMAN NEXT STEP

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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