The lifestyle interventions and independence for elders (LIFE) pilot study: Design and methods
The lifestyle interventions and independence for elders (LIFE) pilot study: Design and methods
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DOI：
10.1016/j.cct.2004.12.005
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发表时间：
2005-04-01
影响因子：
2.2
通讯作者：
Pahor, M
中科院分区：
文献类型：
--
作者：
Rejeski, WJ;Fielding, RA;Pahor, M
LIFE研究是一项多中心试点研究，拟进行一项全规模、双臂随机对照试验，该试验将比较体力活动干预与成功的老龄化教育计划对有风险的久坐老年人发生重大活动障碍（无法完成400米步行）或死亡的影响。为此，将从4个临床研究中心招募400名老年人。所有受试者将接受至少1年的随访;然而，我们将继续随访所有受试者，直至最终随机化个体达到1年。这将使我们能够获取有关维护的更多信息。其他结局将包括下肢体能以及超过4 m和400 m的步态速度。后一项措施将提供与关注的主要结局相关的中间终点干预有效性的数据。初步研究的目的是（a）估计全规模试验所需的样本量，（B）检查身体活动干预对身体功能的几种连续测量的影响的一致性，（c）评估招募的可行性，（d）评价研究依从性和保留率，（d）评估分级护理方法在管理这一高危人群并发疾病方面的效力，以及（e）制定一个全面的监测和确保参与者安全的系统。这一试验阶段的其他目标包括评估与健康有关的生活质量和成本效益。(c)2004年爱思唯尔公司All rights reserved.
The LIFE study is a multicenter pilot for a proposed full scale, two-arm randomized controlled trial that will contrast the effect of a physical activity intervention with a successful aging education program on the occurrence of incident major mobility disability (the inability to complete a 400 m walk) or death in at-risk sedentary older adults. Four hundred older adults from 4 clinical sites will be recruited for this purpose. All participants will be followed for at least 1-year; however, we will continue to follow all participants until the final randomized individual has reached the 1-year mark. This will enable us to acquire additional information about maintenance. Additional outcomes will include lower extremity physical performance as well as gait speed over 4 m and 400 m. These latter measures will provide data on the efficacy of the intervention on intermediate endpoints linked to the primary outcome of interest. The goals of the pilot study are to (a) estimate the sample size needed for a full scale trial, (b) examine the consistency of the effects of the physical activity intervention on several continuous measures of physical function, (c) assess the feasibility of recruitment, (d) evaluate study adherence and retention, (d) evaluate the efficacy of a stepped care approach for managing intercurrent illness in this at-risk population, and (e) develop a comprehensive system for monitoring and ensuring participant safety. Other goals of this pilot phase include assessments of health-related quality of life and cost-effectiveness. (c) 2004 Elsevier Inc. All rights reserved.