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Hypertension: Prediction of Biofeedback Success

This study has been completed.
Information provided by National Center for Complementary and Alternative Medicine (NCCAM)

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Descriptive Information Fields
Brief Title  Hypertension: Prediction of Biofeedback Success
Official Title  Hypertension: Prediction of Biofeedback Success
Brief 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.

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 Phase Phase I
Study Type  Interventional
Study Design  Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Essential Hypertension
Intervention  Behavioral: Biofeedback
MEDLINE PMIDs 11469141,   11172227,   7495917
Links Association for Applied Psychophysiology and Biofeedback This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  60
Start Date  February 2000
Completion Date March 2006
Eligibility Criteria 
  • essential hypertension
  • stages 1 or 2
  • not taking beta blockers or central acting alpha agonists
  • permission from primary care provider
Gender Both
Ages 21 Years to 65 Years
Accepts Healthy Volunteers Yes
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00026065
Organization ID R01 AT000310-02
Secondary IDs ††
Study Sponsor  National Center for Complementary and Alternative Medicine (NCCAM)
Collaborators ††
Investigators 
Principal Investigator:     Carolyn B Yucha, PhD     University of Florida    
Information Provided By National Center for Complementary and Alternative Medicine (NCCAM)
Verification Date August 2006
First Received Date  November 9, 2001
Last Updated Date September 28, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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