Livestream, group movement program for people living with cognitive impairment and care partners: A randomized clinical trial

IF 4.9 Q1 CLINICAL NEUROLOGY

Alzheimer''s and Dementia: Translational Research and Clinical Interventions Pub Date : 2024-05-02 DOI:10.1002/trc2.12467

Deborah E. Barnes, Fei Jiang, Cynthia Benjamin, Jennifer A. Lee, Rebecca L. Sudore, Wolf E. Mehling, Margaret A. Chesney, Linda L. Chao, Francesca M. Nicosia

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引用次数: 0

Abstract

INTRODUCTION

There are few widely-available, evidence-based options to support quality of life (QOL) for people living with Alzheimer's disease and related dementias.

METHODS

We performed a randomized, controlled trial with a Waitlist control group to determine whether an online, livestream, mind-body, group movement program (Moving Together, 1 hour, 2 days/week, 12 weeks) improves QOL in people with cognitive impairment (PWCI) or care partners (CPs) and explore mechanisms of action. The primary outcome for both participants was self-reported QOL. Secondary outcomes and potential mediators included mobility, isolation, well-being, cognitive function, and sleep in PWCI and burden, positive emotions, caregiver self-efficacy, stress management, and sleep in CPs. Blinded assessors collected outcome data at baseline, 12, and 24 weeks. We assessed adverse events including falls through monthly check-in surveys and collected qualitative data through evaluation surveys. Intention-to-treat analyses used linear mixed models to compare mean change over time between groups and calculated standardized effect sizes (ESs).

RESULTS

Ninety-seven dyads enrolled (PWCI: age 76 ± 11 years, 43% female, 80% non-Hispanic White; CPs: age 66 ± 12 years, 78% female, 71% non-Hispanic White); 15% withdrew before 12 weeks and 22% before 24 weeks. PWCI self-reported significantly better QOL from baseline to 12 weeks in the Moving Together group compared to the Waitlist group (ES = 0.474, p = 0.048) and CPs self-reported improved ability to manage stress (ES = 0.484, p = 0.021). Improvements in participant self-reported QOL were mediated by improvements in their self-reported well-being and CP-reported ability to manage stress. Results were similar when the Waitlist group participated in the program (QOL ES = 0.663, p = 0.006; stress management ES = 0.742, p = 0.002) and were supported by qualitative data. Exploratory analyses suggested possible fall reduction in PWCI. There were no study-related serious adverse events.

DISCUSSION

Online programs such as Moving Together offer a scalable strategy for supporting high QOL for PWCI and helping CPs manage stress.

TRIAL REGISTRATION

ClinicalTrials.gov NCT04621448

Highlights

The approval of new medications that slow cognitive decline in people living with Alzheimer's disease and related disorders (ADRD) has raised hope and excitement. However, these medications do not appear to impact quality of life, which is often considered by patients and care partners to be the most important outcome.
In this randomized clinical trial, we found that an evidence-based, online, livestream, mind-body, group movement program significantly and meaningfully improves self-rated quality of life in people with ADRD and helps care partners manage stress. Mediation analyses revealed that the key drivers of improvements in participants’ quality of life were improvements in their feelings of well-being and care partners’ ability to manage stress. Exploratory analyses also suggested a 30% reduction in falls.
These results are important because they suggest that an online program, which is available now and can be performed by people from the comfort of home or other location of choice, could be recommended as a complement or alternative to new therapies to help maximize quality of life for people living with ADRD and their care partners.

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为认知障碍患者和护理伙伴提供的视频流集体运动项目：随机临床试验

引言对于阿尔茨海默氏症及相关痴呆症患者来说，目前几乎没有广泛可用的、以证据为基础的提高生活质量（QOL）的方法。方法我们进行了一项随机对照试验，并设置了候补对照组，以确定在线、直播、心身团体运动项目（"一起运动"，每周 2 天，每次 1 小时，为期 12 周）是否能改善认知障碍患者（PWCI）或护理伙伴（CPs）的生活质量，并探索其作用机制。两名参与者的主要结果都是自我报告的 QOL。次要结果和潜在的中介因素包括：认知障碍患者的行动能力、孤独感、幸福感、认知功能和睡眠；护理伙伴的负担、积极情绪、护理者自我效能、压力管理和睡眠。双盲评估员收集基线、12 周和 24 周的结果数据。我们通过每月签到调查评估包括跌倒在内的不良事件，并通过评估调查收集定性数据。采用线性混合模型进行意向治疗分析，比较不同组间随时间的平均变化，并计算标准化效应大小（ES）。结果有 97 对夫妇报名参加（PWCI：年龄为 76 ± 11 岁，43% 为女性，80% 为非西班牙裔白人；CPs：年龄为 66 ± 12 岁，78% 为女性，71% 为非西班牙裔白人）；15% 在 12 周前退出，22% 在 24 周前退出。从基线到 12 周，"一起行动 "组的 PWCI 自我报告的 QOL 明显优于 "等待名单 "组（ES = 0.474，p = 0.048），CPs 自我报告的压力管理能力有所提高（ES = 0.484，p = 0.021）。参与者自我报告的 QOL 的改善是由其自我报告的幸福感和 CP 报告的压力管理能力的改善所促成的。当候补名单组参与该计划时，结果类似（QOL ES = 0.663，p = 0.006；压力管理 ES = 0.742，p = 0.002），并得到定性数据的支持。探索性分析表明，PWCI 可能会下降。没有发生与研究相关的严重不良事件。讨论像 "一起行动 "这样的在线项目提供了一种可扩展的策略，可支持残疾人的高QOL，并帮助CP管理压力。试验注册 ClinicalTrials.gov NCT04621448 摘要可减缓阿尔茨海默氏症及相关疾病（ADRD）患者认知能力衰退的新药获得批准，给人们带来了希望和兴奋。然而，这些药物似乎并不影响生活质量，而患者和护理伙伴通常认为生活质量是最重要的结果。在这项随机临床试验中，我们发现一项以证据为基础的在线、直播、心身团体运动项目能显著且有意义地改善 ADRD 患者的自评生活质量，并帮助护理伙伴管理压力。中介分析表明，改善参与者生活质量的关键因素是改善他们的幸福感和护理伙伴管理压力的能力。探索性分析还表明，跌倒率降低了 30%。这些结果非常重要，因为它们表明，现在就有一种在线程序，人们可以在舒适的家中或选择的其他地点进行操作，可以推荐这种程序作为新疗法的补充或替代疗法，帮助 ADRD 患者及其护理伙伴最大限度地提高生活质量。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Alzheimer''s and Dementia: Translational Research and Clinical Interventions Medicine-Psychiatry and Mental Health

CiteScore

10.10

自引率

2.10%

发文量

134

审稿时长

10 weeks

期刊介绍： Alzheimer''s & Dementia: Translational Research & Clinical Interventions (TRCI) is a peer-reviewed, open access,journal from the Alzheimer''s Association®. The journal seeks to bridge the full scope of explorations between basic research on drug discovery and clinical studies, validating putative therapies for aging-related chronic brain conditions that affect cognition, motor functions, and other behavioral or clinical symptoms associated with all forms dementia and Alzheimer''s disease. The journal will publish findings from diverse domains of research and disciplines to accelerate the conversion of abstract facts into practical knowledge: specifically, to translate what is learned at the bench into bedside applications. The journal seeks to publish articles that go beyond a singular emphasis on either basic drug discovery research or clinical research. Rather, an important theme of articles will be the linkages between and among the various discrete steps in the complex continuum of therapy development. For rapid communication among a multidisciplinary research audience involving the range of therapeutic interventions, TRCI will consider only original contributions that include feature length research articles, systematic reviews, meta-analyses, brief reports, narrative reviews, commentaries, letters, perspectives, and research news that would advance wide range of interventions to ameliorate symptoms or alter the progression of chronic neurocognitive disorders such as dementia and Alzheimer''s disease. The journal will publish on topics related to medicine, geriatrics, neuroscience, neurophysiology, neurology, psychiatry, clinical psychology, bioinformatics, pharmaco-genetics, regulatory issues, health economics, pharmacoeconomics, and public health policy as these apply to preclinical and clinical research on therapeutics.