Exercise and Severe Depression: Clinical and Biological Analysis

Sponsor

Hospital de Clinicas de Porto Alegre (Other)

Overall Status

Completed

CT.gov ID

NCT01899716

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depression	Other: Exercise	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Exercise and Severe Depression: Clinical and Biological Analysis

Study Start Date :

Jan 1, 2008

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Exercise

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

Other: Exercise

Other Names:

Aerobic Exercise

No Intervention: Control

Outcome Measures

Primary Outcome Measures

Depressive symptoms [2 weeks of hospitalization (14 days)]
Hamilton 17 for depression

Secondary Outcome Measures

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
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)]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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