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Comprehensive geriatric intervention program with and without weekly class-style exercise: research protocol of a cluster randomized controlled trial in Kyoto-Kameoka Study

机译:带有和不带有每周班级锻炼的全面的老年医学干预计划:Kyoto-Kameoka研究中一项整群随机对照试验的研究方案

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Objective: The number of long-term care (LTC) users and the associated expenditures in Japan are increasing dramatically. The national government recommends LTC prevention through activation of communities. However, there is no clear evidence of the effect of population-based comprehensive geriatric intervention program (CGIP) for restraints of LTC users and the associated expenditures in the future. The aims of the current paper are to describe the study protocol and progress of a cluster randomized controlled trial (RCT) with a CGIP in Kameoka City. Methods: The cluster RCT involved random allocation of regions as intervention (n=4,859) and nonintervention (n=7,195). Participants were elderly persons aged ≥65 years without LTC certification who had responded to a mailing survey. The residents living in intervention regions were invited to a physical check-up, and 1,463 people participated (30.3%). These individuals were invited to the CGIP, and 526 accepted. The CGIP comprised instructions on: 1) low-load resistance training using bodyweight, ankle weights, and elastic bands; 2) increasing daily physical activity; 3) oral motor exercise and care; and 4) a well-balanced diet based on a program from Ministry of Health, Labour and Welfare. We allocated the intervention regions randomly into home-based self-care program alone (HB group, 5 regions, n=275) and home-based program+weekly class-style session (CS group, 5 regions, n=251). We evaluated the effects of the CGIP at 12 weeks and at 12 or 15 months on physical function, and are conducting follow-up data collection for an indefinite period regarding LTC certification, medical costs, and mortality. Results and discussion: The study was launched with good response rates in each phase. Participants of both groups significantly increased their step counts by ~1,000 per day from the baseline during the CGIP. This RCT will provide valuable information and evidence about effectiveness of a community-based CGIP.
机译:目标:日本的长期护理(LTC)用户数量及其相关支出正在急剧增加。中央政府建议通过激活社区来预防LTC。但是,没有明确的证据表明,基于人群的老年病综合干预计划(CGIP)对于限制LTC用户和将来的相关支出会产生影响。本文的目的是描述在龟冈市使用CGIP进行的集群随机对照试验(RCT)的研究方案和进展。方法:集群RCT涉及随机分配区域(n = 4,859)和不干预(n = 7,195)。参加者是≥65岁且没有LTC认证的老年人,他们对邮件调查做出了回应。邀请了居住在干预区的居民进行身体检查,共有1,463人参加了检查(占30.3%)。这些人被邀请参加CGIP,并接受了526。 CGIP包含有关以下方面的说明:1)使用体重,脚腕重量和松紧带的低负荷阻力训练; 2)增加日常体育锻炼; 3)口腔运动锻炼及护理; 4)根据厚生劳动省制定的计划,均衡饮食。我们将干预区域随机分为单独的家庭自我护理计划(HB组,5个区域,n = 275)和家庭基础计划+每周一次的课堂式会议(CS组,5个区域,n = 251)。我们评估了CGIP在12周和12或15个月时对身体机能的影响,并就LTC认证,医疗费用和死亡率进行了不确定的随访数据收集。结果与讨论:该研究在每个阶段均获得了良好的回应率。两组参与者每天在CGIP期间的步数都比基线显着增加了约1,000。该RCT将提供有关基于社区的CGIP有效性的有价值的信息和证据。

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