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针对行动不便的成年人的身体活动指导:ComeBACK 实用混合有效性-实施 1 型随机对照试验的方案。

Physical activity coaching for adults with mobility limitations: protocol for the ComeBACK pragmatic hybrid effectiveness-implementation type 1 randomised controlled trial.

机构信息

Institute for Musculoskeletal Health, University of Sydney/ Sydney Local Health District, Sydney, New South Wales, Australia.

Discipline of Physiotherapy, Sydney School of Health Sciences, University of Sydney, Sydney, New South Wales, Australia.

出版信息

BMJ Open. 2020 Nov 3;10(11):e034696. doi: 10.1136/bmjopen-2019-034696.


DOI:10.1136/bmjopen-2019-034696
PMID:33148720
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7640503/
Abstract

INTRODUCTION: Mobility limitation is common and often results from neurological and musculoskeletal health conditions, ageing and/or physical inactivity. In consultation with consumers, clinicians and policymakers, we have developed two affordable and scalable intervention packages designed to enhance physical activity for adults with self-reported mobility limitations. Both are based on behaviour change theories and involve tailored advice from physiotherapists. METHODS AND ANALYSIS: This pragmatic hybrid effectiveness-implementation type 1 randomised control trial (n=600) will be undertaken among adults with self-reported mobility limitations. It aims to estimate the effects on physical activity of: (1) an enhanced 6-month intervention package (one face-to-face physiotherapy assessment, tailored physical activity plan, physical activity phone coaching from a physiotherapist, informational/motivational resources and activity monitors) compared with a less intensive 6-month intervention package (single session of tailored phone advice from a physiotherapist, tailored physical activity plan, unidirectional text messages, informational/motivational resources); (2) the enhanced intervention package compared with no intervention (6-month waiting list control group); and (3) the less intensive intervention package compared with no intervention (waiting list control group). The primary outcome will be average steps per day, measured with the over a 1-week period, 6 months after randomisation. Secondary outcomes include other physical activity measures, measures of health and functioning, individualised mobility goal attainment, mental well-being, quality of life, rate of falls, health utilisation and intervention evaluation. The hybrid effectiveness-implementation design (type 1) will be used to enable the collection of secondary implementation outcomes at the same time as the primary effectiveness outcome. An economic analysis will estimate the cost-effectiveness and cost-utility of the interventions compared with no intervention and to each other. ETHICS AND DISSEMINATION: Ethical approval has been obtained by Sydney Local Health District, Royal Prince Alfred Zone. Dissemination will be via publications, conferences, newsletters, talks and meetings with health managers. TRIAL REGISTRATION NUMBER: ACTRN12618001983291.

摘要

简介:行动受限很常见,通常是由神经和肌肉骨骼健康状况、衰老和/或缺乏身体活动引起的。我们与消费者、临床医生和政策制定者协商后,开发了两种负担得起且可扩展的干预包,旨在增强有自我报告行动受限的成年人的身体活动。这两种方案都基于行为改变理论,并涉及物理治疗师的个性化建议。

方法和分析:这项实用的混合有效性-实施类型 1 随机对照试验(n=600)将在有自我报告行动受限的成年人中进行。它旨在估计以下因素对身体活动的影响:(1)强化的 6 个月干预方案(一次面对面的物理治疗评估、个性化的身体活动计划、由物理治疗师进行的身体活动电话辅导、信息/动机资源和活动监测器)与较不密集的 6 个月干预方案(由物理治疗师进行的单次个性化电话咨询、个性化身体活动计划、单向短信、信息/动机资源)相比;(2)强化干预方案与无干预(6 个月等待名单对照组)相比;(3)较不密集的干预方案与无干预(等待名单对照组)相比。主要结果将是随机分组后 6 个月内每天平均步数,使用 进行为期 1 周的测量。次要结果包括其他身体活动测量、健康和功能测量、个性化行动目标达成、心理健康、生活质量、跌倒率、健康利用和干预评估。混合有效性-实施设计(类型 1)将用于在收集主要有效性结果的同时收集次要实施结果。经济分析将估计与无干预和相互比较时干预措施的成本效益和成本效用。

伦理和传播:悉尼地方卫生区、皇家阿尔弗雷德王子区已获得伦理批准。传播将通过出版物、会议、通讯、演讲和与卫生管理人员的会议进行。

试验注册号:ACTRN12618001983291。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9621/7640503/390541731fcf/bmjopen-2019-034696f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9621/7640503/390541731fcf/bmjopen-2019-034696f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9621/7640503/390541731fcf/bmjopen-2019-034696f01.jpg

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Physical activity coaching for adults with mobility limitations: protocol for the ComeBACK pragmatic hybrid effectiveness-implementation type 1 randomised controlled trial.

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[3]
[DNVF Memorandum: Objectives and Methods of Physical Activity-Related Health Services Research].

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[4]
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BMJ Open. 2022-9-14

[5]
Planning implementation and scale-up of physical activity interventions for people with walking difficulties: study protocol for the process evaluation of the ComeBACK trial.

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本文引用的文献

[1]
"Someone's Got My Back": Older People's Experience of the Coaching for Healthy Ageing Program for Promoting Physical Activity and Preventing Falls.

J Aging Phys Act. 2021-4-1

[2]
Effect of interventions using physical activity trackers on physical activity in people aged 60 years and over: a systematic review and meta-analysis.

Br J Sports Med. 2019-8-9

[3]
Association of Step Volume and Intensity With All-Cause Mortality in Older Women.

JAMA Intern Med. 2019-8-1

[4]
A combined physical activity and fall prevention intervention improved mobility-related goal attainment but not physical activity in older adults: a randomised trial.

J Physiother. 2018-12-21

[5]
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Int J Behav Nutr Phys Act. 2018-6-8

[6]
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Clin Rehabil. 2018-4-26

[7]
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Phys Ther. 2017-5-1

[8]
What is the effect of health coaching on physical activity participation in people aged 60 years and over? A systematic review of randomised controlled trials.

Br J Sports Med. 2017-3-20

[9]
Fatigue contributes to work productivity impairment in patients with axial spondyloarthritis: a cross-sectional UK study.

Clin Exp Rheumatol. 2017

[10]
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Lancet. 2016-9-24

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