Preventing Loss of Independence through Exercise (PLIÉ): A Pilot Clinical Trial in Older Adults with Dementia

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
当前痴呆治疗药物普遍存在疗效有限、不良反应众多且无法延缓疾病进程的问题，因此探索替代性治疗策略具有至关重要的意义。本研究旨在针对轻中度痴呆患者，试点测试一款名为“通过运动预防独立能力丧失（Preventing Loss of Independence through Exercise, PLIÉ）”的新型整合式团体运动项目。该项目聚焦于训练患者完成基础日常功能动作（如坐站转移）的程序记忆，同时提升正念身体觉知水平并促进社交联结。

方法
本研究于美国加利福尼亚州旧金山的成人日间照料项目中开展了一项为期36周的交叉设计试点临床试验，将PLIÉ与常规照护（usual care, UC）进行对比。由设盲的评估人员在基线、18周（交叉干预节点）及36周时，对受试者的躯体表现、认知功能、日常身体机能、痴呆相关行为、生活质量及照料者负担进行评估。本研究的主要结局指标为基线至18周时两组间的变化效应量；次要结局指标为交叉干预前后组内的变化对比。

结果
本研究共纳入12名受试者（PLIÉ组7人，UC组5人），2人脱落（PLIÉ组1人于18周脱落，UC组1人于36周脱落）。受试者中82%为女性，平均年龄为84±4岁；照料者中82%为患者女儿，平均年龄为56±13岁。两组间的效应量未达到统计学显著性，但PLIÉ组相较于UC组，在躯体表现（科恩d值：0.34个标准差）、认知功能（0.76个标准差）、生活质量（0.83个标准差），以及照料者报告的受试者生活质量（0.33个标准差）和照料者负担（0.49个标准差）方面，均呈现出具有临床意义的改善趋势（效应量≥0.25个标准差）。交叉干预前后的组内对比分析结果与上述趋势一致。

结论
PLIÉ是一款新型整合式运动项目，有望改善轻中度痴呆患者的躯体机能、认知功能、生活质量并减轻照料者负担。未来需开展更大样本量的随机对照试验以进一步验证其效果。

试验注册：ClinicalTrials.gov NCT01371214