Establishing the research protocol of a randomized controlled trial to explore the effect of exercise on minor depression among the elderly

我们建立了一项随机对照试验方案来研究运动对老年人轻度抑郁的影响，该方案将于2006财年开始实施。对轻度抑郁症的定义、资格评定方法、干预程序、运动课程内容、统计分析等问题进行了讨论。纳入标准和样本量的选择是基于先前的研究。我们与将进行研究的候选地点的同事进行了沟通，并获得了他们的非正式同意。首席研究人员获得了Umin ID，以便在Umin临床试验注册中心注册该方案。描述该议定书的手稿目前正在准备出版。

We established a randomized controlled trail protocol to study the effect of exercise on minor depression among the elderly, which will be employed from 2006 fiscal year. We discussed the definition of minor depression, the method of eligibility assessment, intervention procedure, the content of exercise classes, statistical analyses, and other points. The inclusion criteria and sample size were chosen based on previous studies. We communicated with the associates at candidate sites where the research will be conducted and obtained their informal consent. The head investigator obtained the UMIN Id to register the protocol in the UMIN Clinical Trials Registry. The manuscript describing the protocol is currently in preparation for publication.