Dose-Response Effects of Inspiratory Muscle Strength Training on Blood Pressure and Vascular Function
NCT ID: NCT07109739
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
144 participants
INTERVENTIONAL
2025-10-24
2027-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
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University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Daniel Craighead, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Locations
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University of Minnesota
Minneapolis, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Favian Morales
Role: primary
Other Identifiers
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STUDY00025718
Identifier Type: -
Identifier Source: org_study_id