Assessing Alternative Approaches for Blood Pressure Control: A3BC Trial
| Status: | Terminated |
|---|---|
| Conditions: | High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 4/21/2016 |
| Start Date: | September 2014 |
| End Date: | August 2015 |
An estimated 76 million adults in the United States over the age of 20 have hypertension
(HTN); which translates into 1 out of 3 adults. Globally the prevalence of HTN is over 25%
for adults, and accounts for approximately 13.5% of all deaths. Given the aging of the
population together with increases in obesity and sedentary behavior, it is not surprising
that HTN is projected to increase significantly over the next several decades; with over 1.5
billion adults having HTN by the year 2025. Thus the public health implications to
preventing and/or reducing elevations in blood pressure are substantial.
This study compares the efficacy of two different non-pharmacologic interventions (device
guided breathing and isometric hand grip exercises) used alone and in combination for
lowering blood pressure. This pilot study will include 30 adults with stage 1 hypertension.
The primary outcome is the change in blood pressure from baseline to 8 weeks. Secondary
outcomes include change in blood pressure from 8 weeks to 16 weeks and acceptability of the
interventions by participants. The knowledge gained from this study can provide information
on non-pharmacologic methods that may be useful in decreasing blood pressure. Such knowledge
may be especially useful for patients for whom access to medications and health care is
limited and among patients unwilling to take or intolerant to pharmacologic therapies.
(HTN); which translates into 1 out of 3 adults. Globally the prevalence of HTN is over 25%
for adults, and accounts for approximately 13.5% of all deaths. Given the aging of the
population together with increases in obesity and sedentary behavior, it is not surprising
that HTN is projected to increase significantly over the next several decades; with over 1.5
billion adults having HTN by the year 2025. Thus the public health implications to
preventing and/or reducing elevations in blood pressure are substantial.
This study compares the efficacy of two different non-pharmacologic interventions (device
guided breathing and isometric hand grip exercises) used alone and in combination for
lowering blood pressure. This pilot study will include 30 adults with stage 1 hypertension.
The primary outcome is the change in blood pressure from baseline to 8 weeks. Secondary
outcomes include change in blood pressure from 8 weeks to 16 weeks and acceptability of the
interventions by participants. The knowledge gained from this study can provide information
on non-pharmacologic methods that may be useful in decreasing blood pressure. Such knowledge
may be especially useful for patients for whom access to medications and health care is
limited and among patients unwilling to take or intolerant to pharmacologic therapies.
Inclusion Criteria:
- Are at least 21 years old, and
- Have Stage 1 high blood pressure. (Defined as a systolic blood pressure between 140
mm Hg and 159 mm Hg (the top blood pressure number) and/or a diastolic blood pressure
between 90 mm Hg and 99 mm Hg (the bottom blood pressure number) in the prior 6
months.)
Exclusion Criteria:
- Take drugs to control blood pressure.
- Have a history of left ventricular hypertrophy.
- Have a history of cardiovascular disease such as stroke, mini-strokes, heart attack,
unstable angina, bypass surgery, stents, angioplasty, abnormal heart rhythms, heart
failure, or peripheral artery disease.
- Have diabetes.
- Have a history of poor kidney function.
- Have an upper arm circumference greater than 17 inches.
- Are currently participating in a formal exercise or weight loss program.
- Plan to participate in a formal exercise or weight loss program in the next 6 months.
- Are pregnant or plan to become pregnant in the next 6 months.
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University of Michigan The University of Michigan was founded in 1817 as one of the...
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