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

Not Applicable

Not yet recruiting

• Conditions: Systolic Hypertension; Brachial Artery Flow-mediated Dilation

• Registration Number: NCT07109739
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-31
• Study First Submitted QC: 2025-07-31
• Study First Posted: 2025-08-07
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-09
• Last Update Posted: 2025-09-16
• Study Start: 2025-11-01
• Primary Completion: 2027-03-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 144

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Systolic Blood Pressure at 6 Weeks	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.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States