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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00179543
First received: September 13, 2005
Last updated: September 18, 2006
Last verified: September 2006
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Mechanisms and Therapeutic Effects of the Relaxation Response in Elderly Hypertensive Patients

Resource links provided by NLM:


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

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00179543

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

No publications provided

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
Study First Received: September 13, 2005
Last Updated: September 18, 2006
Health Authority: United States: Institutional Review Board
US: Centers for Disease Control and Prevention
United States: Food and Drug Administration
US: Department of Health and Human Services
US: National Institutes of Health
US: Office for Human Research Protections

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014