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

NCT07109739 | Recruiting FDA Device

• 1 other identifier: STUDY00025718
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Systolic Blood Pressure at 6 Weeks

  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.

  Week 6

Study Arms (3)

15 Breaths/ Day

ACTIVE COMPARATOR

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

ACTIVE COMPARATOR

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

ACTIVE COMPARATOR

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

Interventions

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.

15 Breaths/ Day; 30 Breaths/ Day; 45 Breaths/ Day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Isolated Systolic Hypertension

Condition Hierarchy (Ancestors)

Essential Hypertension; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Daniel Craighead, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hannah Westerberg

CONTACT

612-624-1588; lewi1241@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 7, 2025
• Study Start: October 24, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)