Clinical trial NCT02110381: Assessing Alternative Approaches for Blood Pressure Control: A3BC Trial
Official title: Assessing Alternative Approaches for Blood Pressure Control: A3BC Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hypertension
Keywords: High blood pressure
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2014-04-10
Enrollment: 32
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Blood Pressure
timeFrame: 8 weeks and 16 weeks
Secondary outcomes:
measure: Adherence to Single Modality Exercise (Device Guided Breathing or Isometric Hand Grip)
timeFrame: 8 weeks
measure: Adherence to Dual Modality Exercise (Device Guided Breathing + Isometric Hand Grip)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Elizabeth A Jackson, MD MPH FACC
role: PRINCIPAL_INVESTIGATOR
References: