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社区户外锻炼干预项目——痴呆症患者独立生活的“享受”计划:一项可行性试点随机对照试验研究方案

Exercise interveNtion outdoor proJect in the cOmmunitY-ENJOY program for independence in dementia: a feasibility pilot randomised controlled trial study protocol.

作者信息

Levinger Pazit, Goh Anita M Y, Dunn Jeremy, Katite Josephine, Paudel Ritu, Onofrio Adrian, Batchelor Frances, Panisset Maya G, Hill Keith D

机构信息

National Ageing Research Institute, Royal Melbourne Hospital, PO Box 2127, Melbourne, VIC, 3050, Australia.

Institute for Health and Sport, Victoria University, Melbourne, Australia.

出版信息

Pilot Feasibility Stud. 2022 Mar 22;8(1):66. doi: 10.1186/s40814-022-01027-x.

DOI:10.1186/s40814-022-01027-x
PMID:35317855
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8938729/
Abstract

BACKGROUND

While the underlying neuropathology of dementia is not curable, interventions and treatment, such as physical activity, can offer physical and functional gains leading to better mobility, independence and quality of life. The Seniors Exercise Park program is an evidence-based physical and social activity program using an innovative design in outdoor exercise equipment specifically designed for older people. This unique program has never been tested with older people living with dementia. This study will evaluate the feasibility of delivering the Seniors Exercise Park program for people living with mild to moderate dementia in residential aged-care. This study will identify the optimal physical activity program, evaluate the safety of equipment usage and determine optimal supervision needs. The potential physical, social, quality of life and cognitive benefits of participation in the Seniors Exercise Park program will also be examined.

METHODS

This is a feasibility pilot randomised controlled design with pre-post evaluation. Adults aged ≥ 60 years who have symptoms of dementia and/or who have been diagnosed with dementia will be recruited from an aged-care facility in Melbourne. Participants allocated to the intervention group will undergo a 12-week structured supervised physical activity program using the outdoor Seniors Exercise Park equipment followed by a 12-week maintenance phase (unstructured physical activity). Participants will be assessed at baseline, 3 and 6 months. Participants allocated to the control group will attend activities provided by the aged-care facility. A sample of 12 participants per group is the targeted sample size. Feasibility will be evaluated in terms of recruitment rate, retention, attendance, overall adherence, dropout rate, adverse events, modifications to the exercise program delivery and supervision needs. A comprehensive suite of cognitive and health-related questionnaires and physical function measures will also be collected.

DISCUSSION

The ENJOY program for independence in dementia will determine the suitability of the Seniors Exercise Park program for people diagnosed with mild to moderate dementia. Outcomes could inform future design of dementia-friendly built environments to increase physical activity participation for residential aged-care facilities.

TRIAL REGISTRATION

This trial is registered with the Australian New Zealand Clinical Trials Registry-Registry Number ACTRN12620000733976 . Registered on the 13th of July 2020.

摘要

背景

虽然痴呆症的潜在神经病理学无法治愈,但诸如体育活动等干预措施和治疗方法可以带来身体和功能上的改善,从而提高行动能力、独立性和生活质量。老年人运动公园项目是一项基于证据的体育和社交活动项目,采用了专门为老年人设计的创新型户外健身器材。这个独特的项目从未在患有痴呆症的老年人中进行过测试。本研究将评估在老年护理机构中为轻度至中度痴呆症患者开展老年人运动公园项目的可行性。本研究将确定最佳体育活动方案,评估器材使用的安全性,并确定最佳监督需求。还将研究参与老年人运动公园项目可能带来的身体、社交、生活质量和认知方面的益处。

方法

这是一项采用前后评估的可行性试点随机对照设计。将从墨尔本的一家老年护理机构招募年龄≥60岁、有痴呆症症状和/或已被诊断患有痴呆症的成年人。分配到干预组的参与者将使用户外老年人运动公园器材进行为期12周的结构化监督体育活动项目,随后是为期12周的维持阶段(非结构化体育活动)。将在基线、3个月和6个月时对参与者进行评估。分配到对照组的参与者将参加老年护理机构提供的活动。每组12名参与者为目标样本量。将从招募率、留存率、出勤率、总体依从性、退出率、不良事件、运动项目实施的调整以及监督需求等方面评估可行性。还将收集一套全面的认知和健康相关问卷以及身体功能测量数据。

讨论

痴呆症独立生活的ENJOY项目将确定老年人运动公园项目对被诊断为轻度至中度痴呆症患者的适用性。研究结果可为未来设计对痴呆症友好的建筑环境提供参考,以增加老年护理机构中体育活动的参与度。

试验注册

本试验已在澳大利亚新西兰临床试验注册中心注册,注册号为ACTRN12620000733976。于2020年7月13日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0223/8939185/49f22441f846/40814_2022_1027_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0223/8939185/292ed35e3f84/40814_2022_1027_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0223/8939185/49f22441f846/40814_2022_1027_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0223/8939185/292ed35e3f84/40814_2022_1027_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0223/8939185/49f22441f846/40814_2022_1027_Fig2_HTML.jpg

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