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

NCT06229873 | Completed FDA Device

• 1 other identifier: 23-0411
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Blood Pressure; Vascular Function; Adherence, Treatment

Keywords

Inspiratory Muscle Strength Training; Above-normal blood pressure; Smartphone Application; Hypertension

Outcome Measures

Primary Outcomes (2)

• Change from baseline in casual systolic blood pressure

  Systolic blood pressure at rest in the clinic setting

  6 weeks

• Change from baseline in home systolic blood pressure

  Systolic blood pressure measured at rest in the home

  6 weeks

Secondary Outcomes (3)

• Change from baseline in endothelial function

  6 weeks

• Change from baseline in maximum inspiratory pressure

  6 weeks

• Difference in adherence to IMST

  6 weeks

Study Arms (2)

App-Based Inspiratory Muscle Strength Training

EXPERIMENTAL

Using a handheld device, participants will perform 30 breaths a day, six days a week, for six weeks. Training will be guided by a smartphone application.

Device: App-Based Inspiratory Muscle Strength Training

Clinic-Based Inspiratory Muscle Strength Training

ACTIVE COMPARATOR

Using a handheld device, participants will perform 30 breaths a day, six days a week, for six weeks. Training will be guided by researchers.

Device: Clinic-Based Inspiratory Muscle Strength Training

Interventions

App-Based Inspiratory Muscle Strength Training DEVICE

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.

App-Based Inspiratory Muscle Strength Training

Clinic-Based Inspiratory Muscle Strength Training DEVICE

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.

Clinic-Based Inspiratory Muscle Strength Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Colorado, Boulder: lead

Study Sites (1)

University of Colorado Boulder

Boulder, Colorado, 80309, United States

Location

MeSH Terms

Conditions

Treatment Adherence and Compliance; Hypertension

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Daniel H Craighead, PhD

  University of Colorado, Boulder

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: January 29, 2024
• Study Start: July 11, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

US (1)