Molecular Processes of the Relaxation Response in Older Adults

This study has been completed.

Sponsors and Collaborators:	Beth Israel Deaconess Medical Center Centers for Disease Control and Prevention
Information provided by:	Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:	NCT00179569

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 II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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:

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

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

Centers for Disease Control and Prevention

Investigators

Principal Investigator:

Jeffery A Dusek, PhD

Beth Israel Deaconess Medical Center

More Information

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

Study placed in the following topic categories:

Stress

ClinicalTrials.gov processed this record on January 14, 2009