Recruiting NCT07109739
Dose-Response Effects of Inspiratory Muscle Strength Training on Blood Pressure and Vascular Function
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: POWERbreathe K5.
- Who it may be relevant to
- Registry conditions: Systolic Hypertension, Brachial Artery Flow-mediated Dilation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device 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.
Primary outcome measures
- Systolic Blood Pressure at 6 Weeks [Time frame: Week 6]
Eligibility 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Minnesota — Minneapolis
Identifiers
NCT: NCT07109739 · STUDY00025718