Molecular Processes of the Relaxation Response in Older Adults

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00179569
First received: September 13, 2005
Last updated: November 2, 2007
Last verified: November 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   60 Years to 80 Years
Genders Eligible for Study:   Both
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
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: NCT00179569

Locations
United States, Massachusetts
BIDMC
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Jeffery A Dusek, PhD Beth Israel Deaconess Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00179569     History of Changes
Other Study ID Numbers: 2004P-000418, H75-CCH-123424, H75-CCH-119124
Study First Received: September 13, 2005
Last Updated: November 2, 2007
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 16, 2014