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ARACOV-02. 新冠后综合征患者的专业营养干预与远程康复:一项随机对照试验方案

ARACOV-02. Specialized nutritional intervention and telerehabilitation in patients with long COVID: Protocol of a randomized controlled trial.

作者信息

Carpallo-Porcar Beatriz, Jiménez-Sánchez Carolina, Calvo Sandra, Irún Pilar, Kolesnyk-Sumskaya Elena, Aller-Blanco Ana Isabel, Beamonte Esther Del Corral

机构信息

Department of Physical Therapy, Faculty of Health Sciences, Universidad San Jorge, Zaragoza, Spain.

IIS Aragón, Zaragoza, Spain.

出版信息

PLoS One. 2025 Apr 29;20(4):e0321811. doi: 10.1371/journal.pone.0321811. eCollection 2025.

Abstract

BACKGROUND

It is estimated that at least 10% of the population infected with SARS-CoV-2 develop Post COVID Condition, which is characterized by a diverse array of symptoms including dyspnea, fatigue, anxiety, depression, and deterioration in quality of life. The SARS-CoV-2 virus can trigger an excessive immune response, characterized by the release of pro-inflammatory cytokines including IL-6, IL-1, TNFα and reactive oxygen species. Specialized Pro Resolving Mediators (SPMs) (17-HAD, 14-HAD and 18_HEPE) that could be useful in Post COVID Condition modulating the inflammatory response. The objective is to determine the change in quality of life, inflammatory profile, functional capacity and emotional variables in a group taking a nutritional supplement (SPMs) plus a telerehabilitation programme.

METHODS

ARACOV-2 study is a double-blind, parallel-group, randomized control trial with two parallel interventions: Nutritional supplement and telerehabilitation vs placebo supplement and telerehabilitation. The primary endpoint will be quality of life (EQ-5L-5D). The intervention will last 12 weeks with a daily intake of omega-3 or placebo and a daily supervised rehabilitation programme using telerehabilitation.

DISCUSSION

This study suggests that SPMs supplementation combined with telerehabilitation may improve inflammation and symptoms like fatigue in Post COVID Condition patients. Both interventions have anti-inflammatory potential, and their combined use could enhance physical and mental health outcomes. This approach offers a promising strategy for managing Post COVID Condition symptoms.

TRIAL REGISTRATION

ClinicalTrials.gov NCT06063031.

摘要

背景

据估计,至少10%感染严重急性呼吸综合征冠状病毒2(SARS-CoV-2)的人群会发展为新冠后状况,其特征是出现多种症状,包括呼吸困难、疲劳、焦虑、抑郁以及生活质量下降。SARS-CoV-2病毒可引发过度免疫反应,其特征是释放促炎细胞因子,包括白细胞介素-6(IL-6)、白细胞介素-1(IL-1)、肿瘤坏死因子α(TNFα)和活性氧。专门的促解决介质(SPMs)(17-羟基二十二碳六烯酸、14-羟基二十二碳六烯酸和18-羟二十碳五烯酸)可能对调节新冠后状况的炎症反应有用。目的是确定服用营养补充剂(SPMs)加远程康复计划的一组人群在生活质量、炎症指标、功能能力和情绪变量方面的变化。

方法

ARACOV-2研究是一项双盲、平行组、随机对照试验,有两种平行干预措施:营养补充剂和远程康复与安慰剂补充剂和远程康复。主要终点将是生活质量(EQ-5L-5D)。干预将持续12周,每天摄入ω-3或安慰剂,并通过远程康复进行每日监督的康复计划。

讨论

本研究表明,补充SPMs并结合远程康复可能改善新冠后状况患者的炎症和疲劳等症状。两种干预措施都具有抗炎潜力,联合使用可能会改善身心健康结果。这种方法为管理新冠后状况症状提供了一种有前景的策略。

试验注册

ClinicalTrials.gov NCT06063031。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b5d9/12040102/a82d912f0d1b/pone.0321811.g001.jpg

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