Exercise and Severe Depression: Clinical and Biological Analysis

Study Overview
=================
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.

Official Title
-----------------
Exercise and Severe Depression: Clinical and Biological Analysis

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Other: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>Aerobic Exercise, 3 times peer week, A dose of 16.5 kcal/kg weight peer week. | Other: Exercise<br> <br> * Other names: Aerobic Exercise;|
| No Intervention: Control<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | 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) |  | 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) | Hamilton Scores at discharge | Discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Severe Depression, Quality of life, Exercise, BDNF, TBARS