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Stress Reactivity of Physical Stressor on Depression

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Physical exercise
Sponsored by
Universidade Federal do Rio de Janeiro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Depression focused on measuring Depression, Physical exercise, Stress

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age above of 60 years old
  • Clinical diagnostic of depression

Exclusion Criteria:

  • Hormonal replacement
  • Physical disease
  • Fasting

Sites / Locations

  • Deolindo Couto Neurology Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Physical exercise

Arm Description

Physical exercise

Outcomes

Primary Outcome Measures

Changes from baseline in cortisol and DHEAS levels to after an acute session of exercise

Secondary Outcome Measures

Full Information

First Posted
January 4, 2013
Last Updated
February 9, 2013
Sponsor
Universidade Federal do Rio de Janeiro
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1. Study Identification

Unique Protocol Identification Number
NCT01791023
Brief Title
Stress Reactivity of Physical Stressor on Depression
Official Title
The Effect of Acute Exercise on Reactivity and Recovery of Cortisol and DHEAS Levels in Depressive and Healthy Older Adults.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio de Janeiro

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Depressive elderly individuals have showed higher basal level of cortisol and lower level of dehydroepiandrosterone (DHEA). Moreover, changes on these hormone levels have also observed in reactivity of an acute stress, such as physical exercise. On the other hand, physical training can modulate the release of these hormones. Therefore, depressive elderly individuals physically actives might show attenuated reactivity of an acute physical stressor compared to sedentary elderly individuals. The aim of these study is to compare the effect of an acute physical stressor on cortisol levels in depressive and healthy individuals, physically actives and sedentaries. Additionally, the sulfated form of DHEA (DHEAS) serves as a reservoir for DHEA, because of that it is expected that DHEAS levels might reduce after the acute physical exercise.
Detailed Description
Depressive and healthy individuals were submitted to one session of 30 minutes of physical exercise of moderate intensity. Before and soon after the exercise it was collected saliva - to analyse cortisol and DHEAS hormones - and some psychological and physical aspects were also collected, such as anamneses, scales of anxiety, temperaments, mood, stress and quality of life. Moreover, during exercise heart rate and mood scale were assessed. To evaluate the reactivity and recovery of physical stressor (physical exercise) saliva tubes and psychological scales were collected 30 minutes and 45 minutes after the end of exercise.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Physical exercise, Stress

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physical exercise
Arm Type
Experimental
Arm Description
Physical exercise
Intervention Type
Other
Intervention Name(s)
Physical exercise
Intervention Description
30 minutes of aerobic exercise on treadmill with moderate intensity.
Primary Outcome Measure Information:
Title
Changes from baseline in cortisol and DHEAS levels to after an acute session of exercise
Time Frame
From before and to after one session of 30 minutes of exercise.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age above of 60 years old Clinical diagnostic of depression Exclusion Criteria: Hormonal replacement Physical disease Fasting
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helena S Moraes, Ms
Organizational Affiliation
Universidade Federal do Rio de Janeiro
Official's Role
Principal Investigator
Facility Information:
Facility Name
Deolindo Couto Neurology Institute
City
Rio de Janeiro
State/Province
RJ
Country
Brazil

12. IPD Sharing Statement

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Stress Reactivity of Physical Stressor on Depression

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