Molecular Processes of the Relaxation Response in Older Adults

Stress Clinical Trial

Official title:

Molecular Processes of the Relaxation Response in Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00179569
• Other study ID #: 2004P-000418
• Secondary ID: H75-CCH-123424H7
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: November 2, 2007
• Start date: August 2005
• Est. completion date: September 2007

Study information

• Verified date: November 2007
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years to 80 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stress

Intervention

Behavioral:
• Relaxation response
8 weeks of relaxation response training

Locations

Country	Name	City	State
United States	BIDMC	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		8 weeks
Secondary	A second area of interest is the relationship between exhaled levels of nitric oxide (NO) and oxygen consumption (VO2) during relaxation response elicitation.		8 weeks