Blood Pressure Clinical Trial
Official title:
Smartphone App-guided Inspiratory Muscle Strength Training for Lowering Systolic Blood Pressure
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.
Status | Not yet recruiting |
Enrollment | 96 |
Est. completion date | November 30, 2025 |
Est. primary completion date | November 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado Boulder | Boulder | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Boulder |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in casual systolic blood pressure | Systolic blood pressure at rest in the clinic setting | 6 weeks | |
Primary | Change from baseline in home systolic blood pressure | Systolic blood pressure measured at rest in the home | 6 weeks | |
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. | 6 weeks | |
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. | 6 weeks | |
Secondary | Difference in adherence to IMST | Percentage of days performing IMST during the intervention between each group | 6 weeks |
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