NCT00179569

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

November 5, 2007

Status Verified

November 1, 2007

First QC Date

September 13, 2005

Last Update Submit

November 2, 2007

Conditions

Stress

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Interventions

Relaxation responseBEHAVIORAL

8 weeks of relaxation response training

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BIDMC

Boston, Massachusetts, 02215, United States

Location

Study Officials

  • Jeffery A Dusek, PhD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

August 1, 2005

Study Completion

September 1, 2007

Last Updated

November 5, 2007

Record last verified: 2007-11

Locations

US(1)