Hypertension: Prediction of Biofeedback Success - Full Text View

Purpose

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.

Condition	Intervention	Phase
Essential Hypertension	Behavioral: Biofeedback	Phase I

MedlinePlus related topics:

High Blood Pressure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Official Title:	Hypertension: Prediction of Biofeedback Success

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Estimated Enrollment:	60
Study Start Date:	February 2000
Estimated Study Completion Date:	March 2006

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.

Eligibility

Ages Eligible for Study:	21 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00026065

Locations


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

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators


Principal Investigator:	Carolyn B Yucha, PhD	University of Florida

More Information

Association for Applied Psychophysiology and Biofeedback This link exits the ClinicalTrials.gov site

Publications:

Yucha CB. Ambulatory blood pressure monitoring: measurement implications for research. J Nurs Meas. 2001 Spring-Summer;9(1):49-59. Review.

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.

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.

Study ID Numbers:	R01 AT000310-02
First Received:	November 9, 2001
Last Updated:	September 28, 2007
ClinicalTrials.gov Identifier:	NCT00026065
Health Authority:	United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

Hypertension

BIofeedback

Non-pharmacological treatment

Prediction

Study placed in the following topic categories:

Vascular Diseases

Essential hypertension

Hypertension

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 03, 2008

Sponsored by:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00026065