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心力衰竭患者心脏远程康复及教育随访的对照临床试验研究方案。

Study protocol for a controlled clinical trial on cardiac telerehabilitation and educational follow-up in patients with heart failure.

作者信息

Betancourt-Peña Jhonatan, Portela-Pino Iago, Martínez-Patiño María José

机构信息

Faculty of Health Rehabilitation, Institución Universitaria Escuela Nacional del Deporte, Cali, Colombia.

Department of Health Sciences, Department of Didactics and Theory of General and Specific Education, University of León, León, Castilla y León, Spain.

出版信息

PLoS One. 2025 Jul 10;20(7):e0327366. doi: 10.1371/journal.pone.0327366. eCollection 2025.

Abstract

BACKGROUND

Heart failure is a primary non-communicable disease in Latin America and the Caribbean, which significantly reduces patients' quality of life. After diagnosis, emphasis is placed on cardiac rehabilitation and patient education regarding healthy lifestyles and habits. Interdisciplinary management is crucial in this process. However, lack of treatment adherence is a recurring issue in this population. In this context, technology allows us to address non-adherence to treatment. Its implementation helps overcome barriers and achieve treatment goals.

OBJECTIVE

To determine the effects of a cardiac telerehabilitation-mediated exercise program and telephone educational follow-up on functional capacity in patients with heart failure, compared with cardiac telerehabilitation and conventional outpatient cardiac rehabilitation.

METHODS

This article presents a SPIRIT-compliant protocol study of a three-arm, controlled, crossover clinical trial using participant blinding and simple sealed envelope block randomization.

CONCLUSION

According to the literature review, this can be considered the first three-arm clinical trial in the telerehabilitation of patients with heart failure. The measurement and intervention instruments are comparable and adequate compared to other studies.

TRIAL REGISTRATION

ClinicalTrials.gov NCT05761639.

摘要

背景

心力衰竭是拉丁美洲和加勒比地区的一种主要非传染性疾病,它会显著降低患者的生活质量。诊断后,重点在于心脏康复以及对患者进行关于健康生活方式和习惯的教育。跨学科管理在这一过程中至关重要。然而,治疗依从性差是这一人群中反复出现的问题。在这种情况下,技术使我们能够解决治疗不依从的问题。其实施有助于克服障碍并实现治疗目标。

目的

与心脏远程康复和传统门诊心脏康复相比,确定心脏远程康复介导的运动计划和电话教育随访对心力衰竭患者功能能力的影响。

方法

本文介绍了一项符合SPIRIT标准的三臂、对照、交叉临床试验的方案研究,采用参与者盲法和简单密封信封区组随机化。

结论

根据文献综述,这可被视为心力衰竭患者远程康复方面的首个三臂临床试验。与其他研究相比,测量和干预工具具有可比性且足够充分。

试验注册

ClinicalTrials.gov NCT05761639。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/041e/12244582/deea8684443b/pone.0327366.g001.jpg

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