Assessing Alternative Approaches for Blood Pressure Control: A3BC Trial

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.

Study Overview

• Status: Terminated
• Conditions: Hypertension
• Intervention / Treatment: Device: Device guided breathing RESPeRATE; Device: Isometric hand grip Zona Plus

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Device Guided Breathing/Combination Therapy; Participants will first do device guided breathing for 8 weeks, followed by 8 weeks of doing BOTH the device guided breathing AND the hand grip exercises. Participants will be given a home blood pressure monitor. Participants will measure blood pressure and heart rate at home for 2 weeks prior to starting any intervention and also during the 16 week of intervention.	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.
Active Comparator: Isometric Hand Grip/Combination Therapy; Participants will first do isometric hand grip exercises for 8 weeks, followed by 8 weeks of doing BOTH the device guided breathing AND the hand grip exercises. Participants will be given a home blood pressure monitor. Participants will measure blood pressure and heart rate at home for 2 weeks prior to starting any intervention and also during the 16 week of intervention.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Blood Pressure	Blood pressure was measured using an automated cuff with subject in a seated position for at least 5 minutes. Six measurements were recorded at 1-minute intervals. The mean was used in analysis.	8 weeks and 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to Single Modality Exercise (Device Guided Breathing or Isometric Hand Grip)	Subjects recorded sessions on a log; they were expected to complete 5 days/week for 8 weeks of single modality exercise for a minimum of 40 reported sessions. Results are reported as number of subjects reporting a minimum of 40 sessions.	8 weeks
Adherence to Dual Modality Exercise (Device Guided Breathing + Isometric Hand Grip)	Subjects recorded sessions on a log; they were expected to complete 5 days/week for 8 weeks of single modality exercise for a minimum of 40 reported sessions. Results are reported as number of subjects reporting a minimum of 40 sessions.	8 weeks

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Elizabeth A Jackson, MD MPH FACC, University of Michigan

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: April 7, 2014
• First Submitted That Met QC Criteria: April 9, 2014
• First Posted (Estimate): April 10, 2014

Study Record Updates

• Last Update Posted (Actual): March 28, 2017
• Last Update Submitted That Met QC Criteria: February 7, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: High blood pressure
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: HUM00086973