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Hypertension: Prediction of Biofeedback Success

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ClinicalTrials.gov Identifier: NCT00026065
Recruitment Status : Completed
First Posted : November 12, 2001
Last Update Posted : October 1, 2007
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Essential Hypertension Behavioral: Biofeedback Phase 1

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Hypertension: Prediction of Biofeedback Success
Study Start Date : February 2000
Estimated Study Completion Date : March 2006
Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00026065


Locations
United States, Florida
University of Florida College of Nursing
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Carolyn B Yucha, PhD University of Florida
More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00026065     History of Changes
Obsolete Identifiers: NCT00030017
Other Study ID Numbers: R01AT000310-02 ( U.S. NIH Grant/Contract )
First Posted: November 12, 2001    Key Record Dates
Last Update Posted: October 1, 2007
Last Verified: August 2006

Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
Hypertension
BIofeedback
Non-pharmacological treatment
Prediction

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases