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KArAT(膝关节置换术活动试验):一项多中心随机对照试验的原理与设计特点

KArAT (Knee Arthroplasty Activity Trial): Rationale and design features of a multicenter randomized controlled trial.

作者信息

Losina Elena, Collins Jamie E, Kumara Mahima, Ehrlich-Jones Linda, Opare-Addo Maame, Safran-Norton Clare, Segal Neil A, Mitchell Lauren M, Kopp Paul T, Selzer Faith, Mass Hanna, Paskewicz Michael, Chang Rowland W, Dunlop Dorothy, Chen Antonia F, Lerner Samuel, Chin Samantha, Pellegrini Christine, Katz Jeffrey N

机构信息

Orthopaedic and Arthritis Center for Outcomes Research, Department of Orthopaedic Surgery, Brigham and Women's Hospital, Boston, MA, USA.

Harvard Medical School, Boston, MA, USA.

出版信息

Osteoarthr Cartil Open. 2024 Aug 23;7(2):100512. doi: 10.1016/j.ocarto.2024.100512. eCollection 2025 Jun.

DOI:10.1016/j.ocarto.2024.100512
PMID:40276263
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12019487/
Abstract

BACKGROUND

Total knee arthroplasty (TKA) is commonly performed to relieve pain in persons with severe knee osteoarthritis. Despite substantial pain reduction and functional improvements, physical activity (PA) does not necessarily increase post TKA. The premise for this randomized trial is that a behavioral intervention invoking internal and external motivators could lead to improvement in PA uptake post TKA.

METHODS

KArAT (the Knee Arthroplasty Activity Trial) is a three-arm multi-center randomized controlled trial designed to establish the efficacy and sustainability of a personalized behavioral intervention in improving PA among TKA recipients with a primary diagnosis of knee osteoarthritis. The three arms include: 1) usual care, 2) attention control with Fitbit activity trackers, and 3) health coaching and financial incentives for reaching personalized PA goals. The primary outcome is defined as the proportion of participants engaged in at least 150 ​min of moderate-to-vigorous physical activity over a given week after the 6-month intervention. We also plan to conduct a cost-effectiveness analysis to establish the value and affordability of the KArAT interventions.

DISCUSSION

This paper aims to outline the rationale, study design, and implementation of KArAT.

TRIAL REGISTRATION

Clinicaltrials.gov NCT04107649.

摘要

背景

全膝关节置换术(TKA)常用于缓解重度膝骨关节炎患者的疼痛。尽管疼痛大幅减轻且功能有所改善,但全膝关节置换术后身体活动(PA)不一定会增加。这项随机试验的前提是,一种激发内在和外在动机的行为干预可能会使全膝关节置换术后的身体活动增加。

方法

KArAT(膝关节置换术活动试验)是一项三臂多中心随机对照试验,旨在确定一种个性化行为干预对改善原发性诊断为膝骨关节炎的全膝关节置换术患者身体活动的有效性和可持续性。三个试验组包括:1)常规护理,2)使用Fitbit活动追踪器的注意力控制,3)针对实现个性化身体活动目标的健康指导和经济激励。主要结局定义为在6个月干预后的给定一周内,参与至少150分钟中度至剧烈身体活动的参与者比例。我们还计划进行成本效益分析,以确定KArAT干预措施的价值和可承受性。

讨论

本文旨在概述KArAT的基本原理、研究设计和实施情况。

试验注册

Clinicaltrials.gov NCT04107649。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4ed6/12019487/2c1cd75edd35/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4ed6/12019487/21a0479840bc/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4ed6/12019487/2c1cd75edd35/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4ed6/12019487/21a0479840bc/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4ed6/12019487/2c1cd75edd35/gr2.jpg

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Financial Incentives and Health Coaching to Improve Physical Activity Following Total Knee Replacement: A Randomized Controlled Trial.经济激励和健康指导对全膝关节置换术后身体活动的影响:一项随机对照试验。
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