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NCT Number: NCT07109739

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location status: Recruiting

Location contact

Hannah Westerberg

CONTACT

[email protected]

612-624-1588

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 and study plan

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.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hannah Westerberg

CONTACT

[email protected]

612-624-1588

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 7, 2025
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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