Hypertension: Prediction of Biofeedback Success

Hypertension, present in more than 50 million Americans, increases the risk of cardiovascular disease and its associated complications. More persons are turning to alternative medicine to deal with their health problems. Biofeedback may reduce blood pressure and/or allow the reduction of antihypertensive medications in some patients, while having no adverse effects. Yet biofeedback therapy is time-intensive and technician-intensive. Therefore, it is critical to be able to predict which patients with essential hypertension are most likely to lower his/her blood pressure using these techniques. This research proposes to test three different means of predicting whether a hypertensive subject will or will not be successful in lowering his/her blood pressure using biofeedback. Sixty hypertensive subjects will be studied over a three-year period. The results of this study will enable those caring for hypertensive persons to recommend biofeedback in an individualized way, thereby promoting adherence.

Study Overview

• Status: Completed
• Conditions: Essential Hypertension
• Intervention / Treatment: Behavioral: Biofeedback

Detailed Description

In the next century, our health care system will attempt to manage chronic illness in the largest aging population ever known. Non-adherence to pharmacological therapy and to non-pharmacological therapy will prove very costly. Hypertension, present in more than 50 million Americans, increases the risk of cardiovascular disease and its associated morbidity and mortality. Thus is it critical that adherence to treatment of hypertension be increased. While medications are effective in certain patients, their adverse effects make compliance with treatment difficult to ensure. In addition, more and more persons are turning to alternative medicine to deal with their health problems. Biofeedback offers an alternative to medical treatment, having been shown to reduce both systolic and diastolic blood pressures and/or allow the reduction of antihypertensive medications in some patients, while having no adverse effects. Yet biofeedback therapy is time-intensive and technician-intensive. Therefore, it is critical to be able to predict which patients with essential hypertension are most likely to lower his/her blood pressure using these techniques.

This research proposes to test three different means of predicting whether a hypertensive subject will or will not be successful in lowering his/her blood pressure using biofeedback. Specifically, the first set of predictive criteria to be tested is that proposed by Weaver & McGrady (1995). This model is derived from five variables: heart rate, finger temperature, forehead muscle tension, plasma rennin response to furosemide, and mean arterial pressure response to furosemide. The second prediction model is based on the magnitude of circadian variations in blood pressure as measured by 24-hour ambulatory blood pressure monitoring. The third prediction model is based on locus of control of behavior. A total of 60 hypertensive subjects will be studied over a three-year period. The results of this study will enable those caring for hypertensive persons to recommend treatment (i.e., biofeedback) in an individualized way, thereby promoting adherence.

• Study Type: Interventional
• Enrollment: 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida College of Nursing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

• essential hypertension
• stages 1 or 2
• not taking beta blockers or central acting alpha agonists
• permission from primary care provider

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Collaborators and Investigators

• Sponsor: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Carolyn B Yucha, PhD, University of Florida

Publications and helpful links

General Publications

• Yucha CB. Ambulatory blood pressure monitoring: measurement implications for research. J Nurs Meas. 2001 Spring-Summer;9(1):49-59.
• Yucha CB, Clark L, Smith M, Uris P, LaFleur B, Duval S. The effect of biofeedback in hypertension. Appl Nurs Res. 2001 Feb;14(1):29-35. doi: 10.1053/apnr.2001.21078.
• Weaver MT, McGrady A. A provisional model to predict blood pressure response to biofeedback-assisted relaxation. Biofeedback Self Regul. 1995 Sep;20(3):229-40. doi: 10.1007/BF01474515.

Helpful Links

• Association for Applied Psychophysiology and Biofeedback

Study record dates

Study Major Dates

• Study Start: February 1, 2000
• Study Completion: March 1, 2006

Study Registration Dates

• First Submitted: November 9, 2001
• First Submitted That Met QC Criteria: November 9, 2001
• First Posted (Estimate): November 12, 2001

Study Record Updates

• Last Update Posted (Estimate): October 1, 2007
• Last Update Submitted That Met QC Criteria: September 28, 2007
• Last Verified: August 1, 2006

More Information

Terms related to this study

• Keywords: Hypertension; Prediction; Non-pharmacological treatment; BIofeedback
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension
• Other Study ID Numbers: R01AT000310-02 (U.S. NIH Grant/Contract)