Exercise and Severe Depression: Clinical and Biological Analysis

December 27, 2013 updated by: Hospital de Clinicas de Porto Alegre

The study aimed to evaluate the use of exercise as a complementary strategy to treat severe major depression in inpatients.

Hypothesis: Exercise can be used as a safe and efficacious complimentary strategy in severe depressed inpatients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

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

  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
        • Hospital de Clincas de Porto Alegre

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of Major Depressive Disorder according to M.I.N.I (DSM-IV) criteria American Psychiatry Association(1994)
  • score of 25 or more on Hamilton-17
  • not being involved in other physical activity programs during the hospitalization
  • aged between 18 and 60 years
  • being able to read, understand, and provide written informed consent

Exclusion Criteria:

  • have three or more cardiovascular risk factors according to Physical Activity Readiness Questionnaire (PAR-Q)
  • are unable to exercise due other clinical condition
  • have diagnosis of Schizophrenia, Bipolar disorder or current use of alcohol or other drugs according to M.I.N.I DSM-IV criteria American Psychiatry Association(1994)
  • if they are taking beta-blocking medications

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Exercise
Aerobic Exercise, 3 times peer week, A dose of 16.5 kcal/kg weight peer week.
Other: Exercise
Other Names:
  • Aerobic Exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depressive symptoms
Time Frame: 2 weeks of hospitalization (14 days)
Hamilton 17 for depression
2 weeks of hospitalization (14 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life
Time Frame: Baseline, after 2 weeks of hospitalization and at discharge (participants will be followed for the duration of hospital stay, an expected average of 3 weeks)
WHOQOL-BREF
Baseline, after 2 weeks of hospitalization and at discharge (participants will be followed for the duration of hospital stay, an expected average of 3 weeks)
Brain-Derived Neurotrophic Factor(BDNF)
Time Frame: Baseline, after 2 weeks of hospitalization and at discharge (participants will be followed for the duration of hospital stay, an expected average of 3 weeks)
Baseline, after 2 weeks of hospitalization and at discharge (participants will be followed for the duration of hospital stay, an expected average of 3 weeks)
Thiobarbituric acid reactive substances(TBARS)
Time Frame: Baseline, after 2 weeks of hospitalization and at discharge (participants will be followed for the duration of hospital stay, an expected average of 3 weeks)
Baseline, after 2 weeks of hospitalization and at discharge (participants will be followed for the duration of hospital stay, an expected average of 3 weeks)
Depressive symptoms at discharge (participants will be followed for the duration of hospital stay, an expected average of 3 weeks)
Time Frame: Discharge
Hamilton Scores at discharge
Discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Investigators

  • Principal Investigator: Felipe B Schuch, MSc, HCPA
  • Study Director: Marcelo PA Fleck, PhD, HCPA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2008

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

June 13, 2013

First Submitted That Met QC Criteria

July 11, 2013

First Posted (Estimate)

July 15, 2013

Study Record Updates

Last Update Posted (Estimate)

December 30, 2013

Last Update Submitted That Met QC Criteria

December 27, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-438

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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