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Completed

NCT Number: NCT01899716

Exercise and Severe Depression: Clinical and Biological Analysis

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Motor Activity

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Clincas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Other

Other names: Aerobic Exercise

Primary outcomes

  1. Depressive symptoms

    Time frame: 2 weeks of hospitalization (14 days)

    Hamilton 17 for depression

Secondary outcomes

  1. 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

  2. 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)

  3. 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)

  4. 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

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Registry information

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Jul 15, 2013
Registry last updated
Dec 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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