Ignite Creation Date:
2024-05-06 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06229873
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-01-16
Brief Title:
Smartphone App-guided Inspiratory Muscle Strength Training for Lowering Systolic Blood Pressure
Sponsor:
University of Colorado Boulder
Organization:
University of Colorado Boulder
Study Overview
Official Title:
Smartphone App-guided Inspiratory Muscle Strength Training for Lowering Systolic Blood Pressure
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Having above-normal blood pressure ie 120 mmHg systolic blood pressure SBP andor 80 mmHg diastolic blood pressure DBP increases risk of developing cardiovascular diseases cognitive declinedementia 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 daysweek reduces SBP by 9 mmHg in adults with above-normal SBP ie 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
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 daysweek reduces SBP by 9 mmHg in adults with above-normal SBP ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None