- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01791023
Stress Reactivity of Physical Stressor on Depression
February 9, 2013 updated by: Helena Sales de Moraes, Universidade Federal do Rio de Janeiro
The Effect of Acute Exercise on Reactivity and Recovery of Cortisol and DHEAS Levels in Depressive and Healthy Older Adults.
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
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
-
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RJ
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Rio de Janeiro, RJ, Brazil
- Deolindo Couto Neurology Institute
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-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age above of 60 years old
- Clinical diagnostic of depression
Exclusion Criteria:
- Hormonal replacement
- Physical disease
- Fasting
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: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Physical exercise
|
30 minutes of aerobic exercise on treadmill with moderate intensity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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.
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From before and to after one session of 30 minutes of exercise.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Helena S Moraes, Ms, Universidade Federal do Rio de Janeiro
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
March 1, 2011
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
January 4, 2013
First Submitted That Met QC Criteria
February 9, 2013
First Posted (Estimate)
February 13, 2013
Study Record Updates
Last Update Posted (Estimate)
February 13, 2013
Last Update Submitted That Met QC Criteria
February 9, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- cortisolexercise01
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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