跳至主要内容
临床试验/NCT03358433
NCT03358433Unknown不适用

Effectiveness of Exercise in the Treatment of Depression in Older People as an Alternative to Drugs Antidepressants in Primary Care

Gerencia de Atención Primaria, Albacete3 个研究点 分布在 1 个国家目标入组 312 人开始时间: 2016年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
312
试验地点
3
主要终点
Improvement in depressive symptoms

研究概览

简要总结

The main objective is to test the non-inferiority of supervised exercise versus antidepressant treatment in reducing depressive symptoms in patients with clinical criteria for depression (according to ICD 10) over a period of 6 months follow-up.

详细描述

This is a randomized clinical trial in primary care in which a total of 312 patients over 65 years with clinically significant depression will be randomly assigned to an exercise program supervised or receive treatment with antidepressant drugs commonly used in clinical practice. At baseline physical fitness of the participants will be checked, and assessments will be made after 15 days and 1, 3 and 6 months. The supervised exercise program will consist of 2 sessions per week in groups of 10-12 patients over a 6 month period in which a sports instructor will train patients to perform at least 30 minutes of regular, moderate-intensity activity with a frequency almost daily, including aerobic exercise and strength training, flexibility and balance. In both groups will be evaluated periodically, among other variables, the state of depressive symptoms, level of physical activity, self-rated health, occurrence of adverse effects and adherence to exercise program or antidepressant treatment. The main outcome measure is the reduction of the baseline score on the scales of depressive symptoms (Montgomery-Asberg Depression Rating Scale and Geriatric Depression Scale).

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
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • People with depression

排除标准

  • Contraindication to exercise

结局指标

主要结局

Improvement in depressive symptoms

时间窗: 6 months

次要结局

未报告次要终点

研究者

发起方
Gerencia de Atención Primaria, Albacete
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jesús López-Torres Hidalgo

MD

Gerencia de Atención Primaria, Albacete

研究点 (3)

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