N/A
N=33
Smartphone App-guided Inspiratory Muscle Strength Training for Lowering Systolic Blood Pressure
Blood Pressure · Vascular Function · Adherence, Treatment
Bottom Line
View on ClinicalTrials.gov: NCT06229873 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Change From Baseline in Casual Systolic Blood Pressure — -2; 0 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- App-Based Inspiratory Muscle Strength Training (Device); Clinic-Based Inspiratory Muscle Strength Training (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Boulder
- Primary completion
- Dec 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Casual Systolic Blood Pressure |
-2; 0 | — |
| PRIMARY Change From Baseline in Home Systolic Blood Pressure |
2; -3 | — |
| SECONDARY Change From Baseline in Endothelial Function |
-0.5; -0.7 | — |
| SECONDARY Change From Baseline in Maximum Inspiratory Pressure |
23; 28 | — |
| SECONDARY Difference in Adherence to Inspiratory Muscle Strength Training |
97; 100 | — |
Summary
This clinical trial aims to assess the efficacy of inspiratory muscle strength training (IMST) guided by a smartphone app vs. IMST delivered in a clinical research setting for lowering systolic blood pressure in adults 18 years and older with elevated blood pressure. Participants will perform IMST for 5 minutes a day, 6 days a week, for 6 weeks.
Eligibility Criteria
Inclusion Criteria
- Age 18+ years
- Ability to provide informed consent
- Willing to accept random assignment to condition
- Systolic blood pressure 120-160 mmHg
- Owns an Apple or Android smartphone
- Body mass index <40 kg/m2
- Subject report of being weight stable in the prior 3 months (<2 kg weight change) and willing to remain weight stable during the 6-week intervention period
- Subjects taking antihypertensive medications will be included provided they meet the other inclusion criteria, including systolic blood pressure. Medication regimen (prescription and dosing) must be stable for at least 3 months prior to enrollment in the study and must remain stable during the 6-week intervention period. These medications will not be withheld prior to experimental protocols.
- If woman of childbearing age:
- Not pregnant (defined as self-report of pregnancy)
- Willing to be abstinent or use approved contraception (i.e., hormonal contraception, intrauterine devices, barrier methods such as condoms with spermicide, and surgical sterilization) throughout the duration of the study
Exclusion Criteria
- Age <18 years
- Participant report of a chronic overt medical condition (e.g., unstable cardiovascular disease, recent myocardial infarction or stroke, cancer) that may make it unsafe to participate in the study under the discretion of the study Medical Director.
- Inability to abstain from consumption of alcohol for 12 hours on experimental days.
- Report of blood donation within 8 weeks prior to enrolling in the study or unwillingness to abstain from donating blood for 8 weeks after completing the study
- Participant report of current ruptured eardrum or any other current condition of the ear
- Participant report of recent abdominal surgery (past 3 months) or current abdominal hernia
- Participant report of current asthma with very low symptom perception, frequent and severe exacerbations, or abnormally low perception of dyspnea
- Participant report of past or current costochondritis (inflammation of the cartilage that joins the ribs to the breastbone)
Data sourced from ClinicalTrials.gov (NCT06229873). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.