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

University of Minnesota (UMN)

Status: Begins enrollment this month

Conditions: Systolic Hypertension; Brachial Artery Flow-mediated Dilation

Treatments: Device: POWERbreathe K5

Study type: Interventional

Funder types: Other

Identifiers

NCT07109739

STUDY00025718

Details and patient eligibility

About

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.

Enrollment: 144 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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144 participants in 3 patient groups

15 Breaths/ Day

Active Comparator group

Description:

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.

Treatment:

Device: POWERbreathe K5

30 Breaths/ Day

Active Comparator group

Description:

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.

Treatment:

Device: POWERbreathe K5

45 Breaths/ Day

Active Comparator group

Description:

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.

Treatment:

Device: POWERbreathe K5