通过运动预防独立性丧失（PLIÉ）：一项针对老年痴呆症患者的试点临床试验
Preventing loss of independence through exercise (PLIÉ): a pilot clinical trial in older adults with dementia.
作者信息
Barnes Deborah E, Mehling Wolf, Wu Eveline, Beristianos Matthew, Yaffe Kristine, Skultety Karyn, Chesney Margaret A
机构信息
Department of Psychiatry, University of California San Francisco, San Francisco, California, United States of America; Department of Epidemiology & Biostatistics, University of California San Francisco, San Francisco, California, United States of America; San Francisco Veterans Affairs Medical Center, San Francisco, California, United States of America.
Department of Family and Community Medicine, University of California San Francisco, San Francisco, California, United States of America; Osher Center for Integrative Medicine, University of California San Francisco, San Francisco, California, United States of America.
出版信息
PLoS One. 2015 Feb 11;10(2):e0113367. doi: 10.1371/journal.pone.0113367. eCollection 2015.
BACKGROUND
Current dementia medications have small effect sizes, many adverse effects and do not change the disease course. Therefore, it is critically important to study alternative treatment strategies. The goal of this study was to pilot-test a novel, integrative group exercise program for individuals with mild-to-moderate dementia called Preventing Loss of Independence through Exercise (PLIÉ), which focuses on training procedural memory for basic functional movements (e.g., sit-to-stand) while increasing mindful body awareness and facilitating social connection.
METHODS
We performed a 36-week cross-over pilot clinical trial to compare PLIÉ with usual care (UC) at an adult day program for individuals with dementia in San Francisco, CA. Assessments of physical performance, cognitive function, physical function, dementia-related behaviors, quality of life and caregiver burden were performed by blinded assessors at baseline, 18 weeks (cross-over) and 36 weeks. Our primary outcomes were effect sizes based on between-group comparisons of change from baseline to 18 weeks; secondary outcomes were within-group comparisons of change before and after cross-over.
RESULTS
Twelve individuals enrolled (7 PLIÉ, 5 UC) and 2 withdrew (1 PLIÉ, 18 weeks; 1 UC, 36 weeks). Participants were 82% women (mean age, 84 ± 4 years); caregivers were 82% daughters (mean age, 56 ± 13 years). Effect sizes were not statistically significant but suggested potentially clinically meaningful (≥ 0.25 SDs) improvement with PLIÉ versus UC for physical performance (Cohen's D: 0.34 SDs), cognitive function (0.76 SDs) and quality of life (0.83 SDs) as well as for caregiver measures of participant's quality of life (0.33 SDs) and caregiver burden (0.49 SDs). Results were similar when within-group comparisons were made before and after cross-over.
CONCLUSIONS
PLIÉ is a novel, integrative exercise program that shows promise for improving physical function, cognitive function, quality of life and caregiver burden in individuals with mild-to-moderate dementia. Larger randomized, controlled trials are warranted.
TRIAL REGISTRATION
ClinicalTrials.gov NCT01371214.
背景
目前用于治疗痴呆症的药物疗效甚微，副作用众多，且无法改变疾病进程。因此，研究替代治疗策略至关重要。本研究的目的是对一项名为“通过运动预防独立性丧失（PLIÉ）”的针对轻至中度痴呆症患者的新型综合团体运动项目进行初步测试，该项目专注于训练基本功能动作（如从坐到站）的程序性记忆，同时增强身体的正念意识并促进社交联系。
方法
我们在加利福尼亚州旧金山为痴呆症患者设立的成人日间项目中进行了一项为期36周的交叉试点临床试验，将PLIÉ与常规护理（UC）进行比较。由不知情的评估人员在基线、18周（交叉点）和36周时对身体表现、认知功能、身体功能、与痴呆症相关的行为、生活质量和照顾者负担进行评估。我们的主要结局是基于从基线到18周组间变化比较的效应量；次要结局是交叉前后组内变化的比较。
结果
12人参与研究（7人接受PLIÉ，5人接受UC），2人退出（1人接受PLIÉ，18周时退出；1人接受UC，36周时退出）。参与者中82%为女性（平均年龄84±4岁）；照顾者中82%为女儿（平均年龄56±13岁）。效应量无统计学意义，但表明与UC相比，PLIÉ在身体表现（科恩d值：0.34标准差）、认知功能（0.76标准差）和生活质量（0.83标准差）以及照顾者对参与者生活质量的评估（0.33标准差）和照顾者负担（0.49标准差）方面可能有具有临床意义（≥0.25标准差）的改善。交叉前后组内比较时结果相似。
结论
PLIÉ是一项新型综合运动项目，有望改善轻至中度痴呆症患者的身体功能、认知功能、生活质量和照顾者负担。有必要进行更大规模的随机对照试验。
试验注册
ClinicalTrials.gov NCT01371214。
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