Molecular Processes of the Relaxation Response in Older Adults

November 2, 2007 updated by: Beth Israel Deaconess Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • BIDMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Deaconess Medical Center

Collaborators

Centers for Disease Control and Prevention

Investigators

  • Principal Investigator: Jeffery A Dusek, PhD, Beth Israel Deaconess Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 15, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

November 4, 2007

Last Update Submitted That Met QC Criteria

November 2, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Other Study ID Numbers

  • 2004P-000418
  • H75-CCH-123424
  • H75-CCH-119124

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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