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

我们建立了一个随机对照试验方案，以研究运动对老年人轻度抑郁症的影响，将从2006财政年度开始使用。探讨了轻度抑郁症的定义、合格评定方法、干预程序、运动课内容、统计分析等问题。根据既往研究选择入选标准和样本量。我们与将开展研究的候选研究中心的同事进行了沟通，并获得了他们的非正式同意。首席研究者获得UMIN Id，以便在UMIN临床试验登记处登记方案。描述该方案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.