Assessing Alternative Approaches for Blood Pressure Control: A3BC Trial

University of Michigan

Status: Terminated

Conditions: Hypertension

Treatments: Device: Device guided breathing RESPeRATE; Device: Isometric hand grip Zona Plus

Study type: Interventional

Funder types: Other

Identifiers

NCT02110381

HUM00086973

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Device Guided Breathing/Combination Therapy

Active Comparator group

Description:

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.

Treatment:

Device: Isometric hand grip Zona Plus

Device: Device guided breathing RESPeRATE

Isometric Hand Grip/Combination Therapy

Active Comparator group

Description:

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.

Treatment:

Device: Isometric hand grip Zona Plus

Device: Device guided breathing RESPeRATE