NCT01791023

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Mar 2011

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 4, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 13, 2013

Completed
Last Updated

February 13, 2013

Status Verified

February 1, 2013

Enrollment Period

1.4 years

First QC Date

January 4, 2013

Last Update Submit

February 9, 2013

Conditions

Depression

Keywords

DepressionPhysical exerciseStress

Outcome Measures

Primary Outcomes (1)

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

    From before and to after one session of 30 minutes of exercise.

Study Arms (1)

Physical exercise

EXPERIMENTAL

Physical exercise

Other: Physical exercise

Interventions

Physical exerciseOTHER

30 minutes of aerobic exercise on treadmill with moderate intensity.

Physical exercise

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • Hormonal replacement
  • Physical disease
  • Fasting

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deolindo Couto Neurology Institute

Rio de Janeiro, Rio de Janeiro, Brazil

Location

MeSH Terms

Conditions

DepressionMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Helena S Moraes, Ms

    Universidade Federal do Rio de Janeiro

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 4, 2013

First Posted

February 13, 2013

Study Start

March 1, 2011

Primary Completion

August 1, 2012

Study Completion

December 1, 2012

Last Updated

February 13, 2013

Record last verified: 2013-02

Locations

BR(1)