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Mechanisms and Therapeutic Effects of the Relaxation Response in Elderly Hypertensive Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00179543
First Posted: September 16, 2005
Last Update Posted: September 19, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Centers for Disease Control and Prevention
Information provided by:
Beth Israel Deaconess Medical Center
  Purpose
The purpose of this study is to determine whether the relaxation response is more effective than attention control in reducing blood pressure and medication dosage in elderly adults with isolated systolic hypertension.

Condition Intervention Phase
Hypertension Behavioral: Relaxation response Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Mechanisms and Therapeutic Effects of the Relaxation Response in Elderly Hypertensive Patients

Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Determine whether the relaxation response is more effective than a health education control in reducing blood pressure in elderly adults with isolated systolic hypertension.

Secondary Outcome Measures:
  • Evaluate whether the relaxation response is more effective than a health education control to safely reduce blood pressure medications in elderly adults with isolated systolic hypertension..

Estimated Enrollment: 122
Study Start Date: August 2001
Detailed Description:
The purpose of this study is to determine whether the relaxation response is more effective than health education training (attention control) in reducing systolic blood pressure and anti-hypertensive medication elimination in elderly adults with isolated systolic hypertension.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 55 years or older
  • currently taking at least 2 anti-hypertensive medications
  • systolic blood pressure between 140-159 mmHg
  • diastolic blood pressure less than 90 mmHg
  • read and understand English
  • access to a telephone
  • ability to attend all study visits

Exclusion Criteria:

  • other cardiovascular disease
  • major medical illness
  • previous experience with any RR eliciting technique
  • current use of:beta-agonist bronchodilators, systemic corticosteroids, anti-convulsants/psychotics, immunosuppressants, cytotoxic therapy, anabolic steroids, antidepressants (other than SSRIs), dicyclomine, bile acid binding resins, or sympathomimetic medication
  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): NCT00179543


Locations
United States, Massachusetts
BIDMC
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Centers for Disease Control and Prevention
Investigators
Principal Investigator: Herbert Benson, MD Beth Israel Deaconess Medical Center
  More Information

ClinicalTrials.gov Identifier: NCT00179543     History of Changes
Other Study ID Numbers: 2001-P-001727
CDC grant: H75-CCH-123424
CDC grant: H75-CCH-119124
CDC grant: R01 DP00039
First Submitted: September 13, 2005
First Posted: September 16, 2005
Last Update Posted: September 19, 2006
Last Verified: September 2006