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Molecular Processes of the Relaxation Response in Older Adults

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00179569
First Posted: September 16, 2005
Last Update Posted: November 5, 2007
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 examine the molecular (nitric oxide) and biochemical (epinephrine, norepinephrine, cortisol and ACTH) parameters that are associated with RR elicitation and which may counteract the effects of acute stress in the elderly.

Condition Intervention Phase
Stress Behavioral: Relaxation response Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Molecular Processes of the Relaxation Response in Older Adults

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

Primary Outcome Measures:
  • A primary goal of this study is to quantify the magnitude of relaxation response elicitation by comparing oxygen consumption during rest versus during elicitation of the relaxation response in a sample of healthy older adults. [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • A second area of interest is the relationship between exhaled levels of nitric oxide (NO) and oxygen consumption (VO2) during relaxation response elicitation. [ Time Frame: 8 weeks ]

Estimated Enrollment: 40
Study Start Date: August 2005
Study Completion Date: September 2007
Intervention Details:
    Behavioral: Relaxation response
    8 weeks of relaxation response training
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 60-80 years of age
  • healthy individuals
  • willing and able to attend treatment sessions
  • willing to learn how to do and practice the relaxation-response
  • access to a working telephone
  • read and write English

Exclusion Criteria:

  • Major medical or psychiatric illness
  • asthma or seasonal allergies (resulting in nitric oxide levels >60 ppb)
  • smoking
  • previous relaxation-response practice
  • current use of the following medications: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): NCT00179569


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: Jeffery A Dusek, PhD Beth Israel Deaconess Medical Center
  More Information

ClinicalTrials.gov Identifier: NCT00179569     History of Changes
Other Study ID Numbers: 2004P-000418
H75-CCH-123424
H75-CCH-119124
First Submitted: September 13, 2005
First Posted: September 16, 2005
Last Update Posted: November 5, 2007
Last Verified: November 2007