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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.
Having above-normal blood pressure, i.e., ≥120 mmHg systolic blood pressure (SBP) and/or ≥80 mmHg diastolic blood pressure (DBP), increases risk of developing cardiovascular diseases, cognitive decline/dementia, chronic kidney disease, and other chronic health problems. Approximately 60% of all US adults have above-normal BP, primarily driven by above-normal SBP.
Currently, above-normal SBP is the single largest modifiable risk factor for cardiovascular mortality in the United States. Thus, developing novel strategies for lowering SBP is an urgent public health and biomedical research priority.
Guidelines emphasize regular aerobic exercise as a first-line intervention for all stages of above-normal systolic blood pressure (SBP). Current guidelines call for ≥150 minutes of aerobic activity per week. However, only ~50% of US adults meet these aerobic exercise guidelines. The greatest reported barrier to achieving aerobic exercise guidelines is lack of time. High-resistance inspiratory muscle strength training (IMST) is a time-efficient (5 minutes per session) lifestyle intervention consisting of 30 inspiratory maneuvers performed against a high resistance. Preliminary data suggest 6-weeks of IMST performed 6 days/week reduces SBP by 9 mmHg in adults with above-normal SBP (i.e., greater than 120 mmHg) at baseline. Importantly, this reduction in SBP is equal to or greater than the reduction in blood pressure typically achieved with time- and effort-intensive healthy lifestyle strategies like conventional aerobic exercise.
The investigators hope utilizing a smartphone app to guide IMST will promote the translation of IMST for widespread use and improving public health. The investigators will conduct a randomized, controlled, single-blind, parallel group design clinical trial to assess the efficacy of 6-weeks of IMST (55%-75% maximal inspiratory pressure) delivered in the research clinic by the study investigators vs. IMST delivered entirely via a smartphone app without investigator involvement, for lowering resting and home SBP in adults aged 18 years and older with above-normal SBP (120-160 mmHg) at baseline. The investigators will also assess the effect of IMST on endothelial function, large-elastic artery stiffness, and potential mechanisms of action.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Casual Systolic Blood Pressure | Change in systolic blood pressure at rest in the clinic setting | 6 weeks |
| Change From Baseline in Home Systolic Blood Pressure | Change in systolic blood pressure measured at rest in the home | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Endothelial Function | A procedure called brachial artery flow-mediated dilation will be used to assess endothelium-dependent vasodilation. During this procedure a blood pressure cuff will be placed on the forearm and then inflated for 5 minutes to restrict blood flow. During the procedure a video of the brachial artery will be taken with an ultrasound. The video will be analyzed to determine the peak change in the blood vessels diameter. Blood flow response after cuff deflation will also be assessed. |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel H Craighead, PhD | University of Colorado, Boulder | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Boulder | Boulder | Colorado | 80309 | United States |
18 participants were assigned to the App-based group, and 15 participants were assigned to the Clinic-based group. Once enrolled, no participants were excluded from the study before assignment to a group.
Recruitment took place between June 2024 and October 2025.
Participants were recruited from Boulder County and the surrounding areas using newspaper advertisements, social media advertisements, and flyers, along with the use of ResearchMatch and BuildClinical.
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| ID | Title | Description |
|---|---|---|
| FG000 | App-Based Inspiratory Muscle Strength Training | 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. |
| FG001 | Clinic-Based Inspiratory Muscle Strength Training |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 2, 2025 |
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Parallel Assignment
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| 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. |
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| 6 weeks |
| Change From Baseline in Maximum Inspiratory Pressure | Participants will use a hand-held breathing device to assess their maximum inspiratory pressure once a week during the intervention. During the maximum inspiratory pressure test, participants will inspire into the device as powerfully as they can. Results from the maximum inspiratory pressure tests will be assessed. | 6 weeks |
| Difference in Adherence to Inspiratory Muscle Strength Training | Percentage of days performing inspiratory muscle strength training during the intervention between each group | 6 weeks |
Using a handheld device, participants will perform 30 breaths a day, six days a week, for six weeks. Training will be guided by researchers. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | App-Based Inspiratory Muscle Strength Training | 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. |
| BG001 | Clinic-Based Inspiratory Muscle Strength Training | Using a handheld device, participants will perform 30 breaths a day, six days a week, for six weeks. Training will be guided by researchers. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Casual systolic blood pressure | Mean | Standard Deviation | mmHg |
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| Home systolic blood pressure | Mean | Standard Deviation | mmHg |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Casual Systolic Blood Pressure | Change in systolic blood pressure at rest in the clinic setting | Posted | Mean | Standard Deviation | mmHg | 6 weeks |
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| Primary | Change From Baseline in Home Systolic Blood Pressure | Change in systolic blood pressure measured at rest in the home | Posted | Mean | Standard Deviation | mmHg | 6 weeks |
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| Secondary | Change From Baseline in Endothelial Function | A procedure called brachial artery flow-mediated dilation will be used to assess endothelium-dependent vasodilation. During this procedure a blood pressure cuff will be placed on the forearm and then inflated for 5 minutes to restrict blood flow. During the procedure a video of the brachial artery will be taken with an ultrasound. The video will be analyzed to determine the peak change in the blood vessels diameter. Blood flow response after cuff deflation will also be assessed. | Posted | Mean | Standard Deviation | % change in diameter | 6 weeks |
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| Secondary | Change From Baseline in Maximum Inspiratory Pressure | Participants will use a hand-held breathing device to assess their maximum inspiratory pressure once a week during the intervention. During the maximum inspiratory pressure test, participants will inspire into the device as powerfully as they can. Results from the maximum inspiratory pressure tests will be assessed. | Posted | Mean | Standard Deviation | mmHg | 6 weeks |
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| Secondary | Difference in Adherence to Inspiratory Muscle Strength Training | Percentage of days performing inspiratory muscle strength training during the intervention between each group | Posted | Mean | Standard Deviation | Percentage of days | 6 weeks |
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From enrollment until last clinical visit, representing an average of 10 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | App-Based Inspiratory Muscle Strength Training | 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. | 0 | 17 | 0 | 17 | 2 | 17 |
| EG001 | Clinic-Based Inspiratory Muscle Strength Training | Using a handheld device, participants will perform 30 breaths a day, six days a week, for six weeks. Training will be guided by researchers. | 0 | 15 | 0 | 15 | 7 | 15 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated white blood cell count | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Dizziness | General disorders | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Diaphragm pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Ear pain | Ear and labyrinth disorders | Non-systematic Assessment |
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| Bruise from blood draw | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Jones | University of Colorado Boulder | 303-492-2485 | imstapp@colorado.edu |
| Apr 6, 2026 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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