Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Hypertension: Prediction of Biofeedback Success

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00026065
First received: November 9, 2001
Last updated: September 28, 2007
Last verified: August 2006

November 9, 2001
September 28, 2007
February 2000
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00026065 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Hypertension: Prediction of Biofeedback Success
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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Essential Hypertension
Behavioral: Biofeedback
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
March 2006
Not Provided
  • essential hypertension
  • stages 1 or 2
  • not taking beta blockers or central acting alpha agonists
  • permission from primary care provider
Both
21 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00026065
R01 AT000310-02
Not Provided
Not Provided
National Center for Complementary and Alternative Medicine (NCCAM)
Not Provided
Principal Investigator: Carolyn B Yucha, PhD University of Florida
National Center for Complementary and Alternative Medicine (NCCAM)
August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP