Dose-Response Effects of Inspiratory Muscle Strength Training on Blood Pressure and Vascular Function
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Minnesota
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
POWERbreathe K5
DeviceThe 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.
Treatment groups
144 Participants
are divided into 3 treatment groupsGroup A: 15 Breaths/ DayActive comparator 1 intervention
Group B: 30 Breaths/ DayActive comparator 1 intervention
Group C: 45 Breaths/ DayActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Systolic Blood Pressure at 6 Weeks
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.
Time frame
Week 6Sponsors and contacts
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Source ClinicalTrials.gov