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

Launched by UNIVERSITY OF COLORADO, BOULDER · Jan 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether a smartphone app can help people lower their systolic blood pressure, which is the top number in a blood pressure reading. Participants will engage in a simple exercise called inspiratory muscle strength training (IMST) for just 5 minutes a day, six days a week, over a period of six weeks. The study is looking to compare the effectiveness of this app-guided training with traditional training done in a clinical setting.

To be eligible for this study, you must be at least 18 years old, have elevated blood pressure between 120 and 160 mmHg, and own a smartphone (either Apple or Android). Participants should also be stable in their weight and on any blood pressure medications for at least three months before the study. If you join, you can expect to receive guidance through the app to help with the exercises, and your participation will contribute to understanding how technology can assist in managing blood pressure. Please note that certain health conditions may exclude you from participation, so it's important to discuss your medical history with the study team.

Gender

ALL

Eligibility 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)