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COMPLETED

NCT06229873

Smartphone App-guided Inspiratory Muscle Strength Training for Lowering Systolic Blood Pressure

Sponsor: University of Colorado, Boulder

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-06-27

Completion Date

2025-12-31

Last Updated

2026-05-19

Healthy Volunteers

Yes

Conditions

Blood Pressure Vascular Function Adherence, Treatment

Interventions

DEVICE

App-Based Inspiratory Muscle Strength Training

Participants will perform inspiratory muscle strength training guided by a smartphone application. Participants will perform 30 breaths a day at 75% of maximal inspiratory pressure, 6 days a week, for 6 weeks. All training sessions will be guided by the smartphone application.

DEVICE

Clinic-Based Inspiratory Muscle Strength Training

Participants will perform inspiratory muscle strength training guided by researchers. Participants will perform 30 breaths a day at 75% of maximal inspiratory pressure, 6 days a week, for 6 weeks. One training session each week will be performed in the research clinic.

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)

Locations (1)

University of Colorado Boulder

Boulder, Colorado, United States