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创新远程康复强化护理方案(ITECP)在中青年出血性脑卒中患者中提高运动依从性的研究:一项多中心随机对照试验方案。

Innovative Telerehabilitation Enhanced Care Programme (ITECP) in young and middle-aged patients with haemorrhagic stroke to improve exercise adherence: protocol of a multicentre randomised controlled trial.

机构信息

Department of Neurosurgery, Nanjing Drum Tower Hospital Clinical College of Nanjing University of Chinese Medicine, Nanjing, China.

School of Nursing, Nanjing University of Chinese Medicine, Nanjing, China.

出版信息

BMJ Open. 2023 Dec 21;13(12):e072268. doi: 10.1136/bmjopen-2023-072268.

Abstract

INTRODUCTION

Exercise rehabilitation is crucial for promoting the rehabilitation of limb motor function in people who had stroke and is related to a better prognosis. However, the exercise adherence of patients is low, which affects the effect of exercise rehabilitation. This study aims to evaluate the effects of the Innovative Telerehabilitation Enhanced Care Programme (ITECP) on exercise adherence in young and middle-aged patients with haemorrhagic stroke. We hypothesise that patients trained with ITECP will show greater improvement in exercise adherence and muscle strength than patients with routine exercise rehabilitation.

METHODS AND ANALYSIS

This is a randomised controlled, evaluator-blinded multicentre superiority trial to be implemented at four tertiary grade-A hospitals in eastern, western, northern and central China. Patients in the experimental group will receive ITECP while those in the control group will receive routine exercise rehabilitation. Both groups will receive routine care. The primary outcome measure is exercise adherence, while secondary outcome measures include muscle strength, activities of daily living, exercise self-efficacy, quality of life, rate of exercise-related adverse events and readmission. These will be measured at baseline, predischarge as well as 1 and 3 months postdischarge.

ETHICS AND DISSEMINATION

The study has obtained ethical approval from the Medical Ethics Committee of Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School (2021-381-02). The results will be shared with young and middle-aged patients with haemorrhagic stroke, policy-makers, the general public, as well as academia.

TRIAL REGISTRATION NUMBER

Chinese Clinical Trials Registry (ChiCTR 2200066498).

摘要

简介

运动康复对于促进脑卒中患者肢体运动功能康复至关重要,与更好的预后相关。然而,患者的运动依从性较低,这会影响运动康复的效果。本研究旨在评估创新远程康复增强护理计划(ITECP)对中青年出血性脑卒中患者运动依从性的影响。我们假设接受 ITECP 训练的患者在运动依从性和肌肉力量方面的改善将大于接受常规运动康复的患者。

方法和分析

这是一项在中国东部、西部、北部和中部的四家三级甲等医院进行的随机对照、评估者盲法、多中心优效性试验。实验组患者将接受 ITECP,对照组患者将接受常规运动康复。两组均将接受常规护理。主要结局指标是运动依从性,次要结局指标包括肌肉力量、日常生活活动、运动自我效能、生活质量、与运动相关的不良事件发生率和再入院率。这些指标将在基线、出院前以及出院后 1 个月和 3 个月进行测量。

伦理和传播

该研究已获得南京鼓楼医院、南京大学医学院附属医院医学伦理委员会的批准(2021-381-02)。研究结果将与中青年出血性脑卒中患者、政策制定者、公众以及学术界分享。

试验注册编号

中国临床试验注册中心(ChiCTR2200066498)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aa3b/10749011/caec0c5d1b96/bmjopen-2023-072268f01.jpg

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