Exercise and Severe Depression: Clinical and Biological Analysis

Not Applicable

Completed

• Conditions: Depression
• Interventions: Other: Exercise

• Registration Number: NCT01899716
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-05
• Study First Submitted: 2013-06-13
• Study First Submitted QC: 2013-07-11
• Study First Posted: 2013-07-15
• Last Update Submitted: 2013-12-27
• Last Update Posted: 2013-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise	Exercise	Aerobic Exercise, 3 times peer week, A dose of 16.5 kcal/kg weight peer week.

Primary Outcome Measures

Name	Time	Method
Depressive symptoms	2 weeks of hospitalization (14 days)	Hamilton 17 for depression

Secondary Outcome Measures

Name	Time	Method
Brain-Derived Neurotrophic Factor(BDNF)	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)	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)
Quality of Life	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
Depressive symptoms at discharge (participants will be followed for the duration of hospital stay, an expected average of 3 weeks)	Discharge	Hamilton Scores at discharge

Trial Locations

Locations (1)

Hospital de Clincas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil