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临床试验/NCT01899716
NCT01899716已完成不适用

Exercise and Severe Depression: Clinical and Biological Analysis

Hospital de Clinicas de Porto Alegre1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2008年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Depressive symptoms

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Exercise

Experimental

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

干预措施: Exercise (Other)

Control

No Intervention

结局指标

主要结局

Depressive symptoms

时间窗: 2 weeks of hospitalization (14 days)

Hamilton 17 for depression

次要结局

  • 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))
  • Depressive symptoms at discharge (participants will be followed for the duration of hospital stay, an expected average of 3 weeks)(Discharge)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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