Hypertension: Prediction of Biofeedback Success

Essential Hypertension Clinical Trial

Official title:

Hypertension: Prediction of Biofeedback Success

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00026065
• Other study ID #: R01AT000310-02
• Status: Completed
• Phase: Phase 1
• First received: November 9, 2001
• Last updated: September 28, 2007
• Start date: February 2000
• Est. completion date: March 2006

Study information

• Verified date: August 2006
• Source: National Center for Complementary and Integrative Health (NCCIH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Other known NCT identifiers

• NCT00030017

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

• essential hypertension

• stages 1 or 2

• not taking beta blockers or central acting alpha agonists

• permission from primary care provider

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Behavioral:
• Biofeedback

Locations

Country	Name	City	State
United States	University of Florida College of Nursing	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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

External Links

•   Association for Applied Psychophysiology and Biofeedback