Assessing Alternative Approaches for Blood Pressure Control: A3BC Trial

Not Applicable

Terminated

• Conditions: Hypertension
• Interventions: Device: Device guided breathing RESPeRATE; Device: Isometric hand grip Zona Plus

• Registration Number: NCT02110381
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-07
• Study First Submitted QC: 2014-04-09
• Study First Posted: 2014-04-10
• Study Start: 2014-09
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2017-02
• Results First Submitted: 2017-02-07
• Results First Submitted QC: 2017-02-07
• Last Update Submitted: 2017-02-07
• Results First Posted: 2017-03-28
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 32

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.)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Isometric Hand Grip/Combination Therapy	Isometric hand grip Zona Plus	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 Guided Breathing/Combination Therapy	Device guided breathing RESPeRATE	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.
Isometric Hand Grip/Combination Therapy	Device guided breathing RESPeRATE	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 Guided Breathing/Combination Therapy	Isometric hand grip Zona Plus	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.

Primary Outcome Measures

Name	Time	Method
Change in Blood Pressure	8 weeks and 16 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Adherence to Dual Modality Exercise (Device Guided Breathing + Isometric Hand Grip)	8 weeks	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.
Adherence to Single Modality Exercise (Device Guided Breathing or Isometric Hand Grip)	8 weeks	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.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States