Assessing Alternative Approaches for Blood Pressure Control: A3BC Trial

Stopped early · Not applicable

Conditions studied: Hypertension

In brief

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.

Key facts

Study ID

NCT02110381

Run by

University of Michigan

People needed

32

Starts

2014-09-01

Expected to finish

2015-08-01

Last updated by the study team

2017-03-28

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.)

You may not qualify if…

• 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.

Where it is running

• University of Michigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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