Recruiting

Inspiratory Muscle Strength Training for Adults with High Blood Pressure

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

POWERbreathe K5

Device
Who is being recruted

Essential Hypertension+2

+ Isolated Systolic Hypertension

+ Cardiovascular Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: October 2025
See protocol details

Summary

Principal SponsorUniversity of Minnesota
Study ContactHannah Westerberg
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 24, 2025

Actual date on which the first participant was enrolled.

This study focuses on understanding how a specific type of breathing exercise, called Inspiratory Muscle Strength Training (IMST), affects blood pressure and blood vessel function in adults who have higher than normal systolic blood pressure. Systolic blood pressure is the pressure in the arteries when the heart beats. The study aims to determine how different levels of this breathing exercise can improve vascular health and potentially lower blood pressure over a period of six weeks. This research is important as it explores a non-drug method to manage high blood pressure, which could provide a new option for individuals seeking alternative or additional treatment methods. Participants in this study will engage in Inspiratory Muscle Strength Training over six weeks. This involves specific breathing exercises designed to strengthen the muscles used in breathing. The study will track changes in blood pressure and the health of blood vessels to understand the impact of the training. There are no specific risks or benefits mentioned, but the study's goal is to evaluate how effective this non-invasive method can be in improving blood pressure and vascular function. Results from this study may guide future treatments for managing high blood pressure without medication.

Official TitleDose-Response Effects of Inspiratory Muscle Strength Training on Blood Pressure and Vascular Function
NCT07109739
Principal SponsorUniversity of Minnesota
Study ContactHannah Westerberg
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

144 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Essential HypertensionIsolated Systolic HypertensionCardiovascular DiseasesHypertensionVascular Diseases

Criteria

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 Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Group II

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.

Group III

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.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

University of Minnesota

Minneapolis, United StatesOpen University of Minnesota in Google Maps
Recruiting
One Study Center