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Assessing Alternative Approaches for Blood Pressure Control: A3BC Trial

NCT02110381 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2017-03-28

Study results available
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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.

Conditions

Interventions

DEVICE

Device guided breathing RESPeRATE

Participants will use a device called RESPeRATE which will measure how many breaths they take per minute. A strap wraps around the participants chest that measures breathing frequency. Headphones plug into the device to inform participants about their breathing. The device will help guide participants to breathe slowly using musical tones, with a goal of about ten breaths per minute. Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit.

DEVICE

Isometric hand grip Zona Plus

Participants will use a device called the Zona Plus, which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing the device followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise. Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit.

Sponsors & Collaborators

Principal Investigators

  • Elizabeth A Jackson, MD MPH FACC · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02110381 on ClinicalTrials.gov