DepressionNCT01791023
Stress Reactivity of Physical Stressor on Depression
A study testing Physical exercise in people with Depression, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Physical exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2011to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age above of 60 years old
- Clinical diagnostic of depression
Who cannot join
- Hormonal replacement
- Physical disease
- Fasting
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Depression
- Being tested
- Physical exercise
- Keywords
- Depression, Physical exercise, Stress
- Medical subject headings
- Depression, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exerciseOther
30 minutes of aerobic exercise on treadmill with moderate intensity.
| Study group | Role | What they receive |
|---|---|---|
| Physical exercise | Experimental | Physical exercise Receives: Other: Physical exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in cortisol and DHEAS levels to after an acute session of exercise
Measured: From before and to after one session of 30 minutes of exercise.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2013 (estimated)
- Study startMar 2011
- Primary completionAug 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helena Sales de Moraes, Universidade Federal do Rio de Janeiro
- Investigators
- Helena S Moraes, Ms, Principal investigator, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01791023
- Sponsor's protocol ID
- cortisolexercise01
- Status last verified
- Feb 2013
- First submitted
- 4 Jan 2013
- Last updated
- 13 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acute Exercise on Reactivity and Recovery of Cortisol and DHEAS Levels in Depressive and Healthy Older Adults.
- ClinicalTrials.gov ID
- NCT01791023
- Acronym / sponsor ID
- cortisolexercise01
- Conditions
- Depression
- Keywords
- Depression, Physical exercise, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 13 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physical exercise | Experimental | Other: Physical exercisePhysical exercise |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age above of 60 years old
- Clinical diagnostic of depression
Key exclusion criteria (3 listed)
- Hormonal replacement
- Physical disease
- Fasting
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical exercise30 minutes of aerobic exercise on treadmill with moderate intensity. | Other | Physical exercise |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helena S Moraes, Ms principal investigator
Universidade Federal do Rio de Janeiro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercise in people with Depression, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2013.