Using a smartphone app to guide breathing exercises for lowering blood pressure
Smartphone App-guided Inspiratory Muscle Strength Training for Lowering Systolic Blood Pressure
PHASE1 · University of Colorado, Boulder · NCT06229873
This study is testing whether using a smartphone app for breathing exercises can help adults with high blood pressure lower their numbers better than traditional methods.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Colorado, Boulder (other) |
| Locations | 1 site (Boulder, Colorado) |
| Trial ID | NCT06229873 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of smartphone app-guided inspiratory muscle strength training (IMST) compared to traditional clinic-based IMST in reducing systolic blood pressure in adults with elevated blood pressure. Participants will engage in a 5-minute daily IMST routine for six weeks, aiming to provide a time-efficient alternative to conventional aerobic exercise. The study addresses the public health challenge of high systolic blood pressure, which is a major risk factor for cardiovascular diseases. By leveraging technology, the trial seeks to enhance adherence to a critical health intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with systolic blood pressure between 120-160 mmHg who own a smartphone.
Not a fit: Patients with severely elevated blood pressure above 160 mmHg or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a convenient and effective method for lowering blood pressure in individuals with elevated levels.
How similar studies have performed: Preliminary data from similar interventions suggest that inspiratory muscle strength training can effectively reduce blood pressure, indicating potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Boulder, Colorado
- University of Colorado Boulder — Boulder, Colorado, United States (RECRUITING)
Study contacts
- Principal investigator: Daniel H Craighead, PhD — University of Colorado, Boulder
- Study coordinator: Daniel H Craighead, PhD
- Email: daniel.craighead@colorado.edu
- Phone: 303-492-3010
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Blood Pressure, Vascular Function, Adherence, Treatment, Inspiratory Muscle Strength Training, Above-normal blood pressure, Smartphone Application, Hypertension