Assessing Alternative Approaches for Blood Pressure Control: A3BC Trial

NCT ID: NCT02110381

Last Updated: 2017-03-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-08-31

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Device guided breathing RESPeRATE

Intervention Type: DEVICE

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.

Isometric hand grip Zona Plus

Intervention Type: DEVICE

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.

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.

Group Type: ACTIVE_COMPARATOR

Device guided breathing RESPeRATE

Intervention Type: DEVICE

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.

Isometric hand grip Zona Plus

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth A. Jackson

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth A Jackson, MD MPH FACC

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00086973

Identifier Type: -

Identifier Source: org_study_id