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针对新冠后综合征患者的基于网络的多模式远程康复:一项随机对照试验方案

Multimodal Web-Based Telerehabilitation for Patients With Post-COVID-19 Condition: Protocol for a Randomized Controlled Trial.

作者信息

Tomaskovic Aleksandar, Weber Vincent, Ochmann David T, Neuberger Elmo Wanja, Lachtermann Ella, Brahmer Alexandra, Haller Nils, Hillen Barlo, Enders Kira, Eggert Viktoria, Zeier Peter, Lieb Klaus, Simon Perikles

机构信息

Department of Sports Medicine, Prevention and Rehabilitation, Institute of Sport Science, Johannes Gutenberg University Mainz, Mainz, Germany.

Department of Sport and Exercise Science, University of Salzburg, Salzburg, Austria.

出版信息

JMIR Res Protoc. 2025 May 21;14:e65044. doi: 10.2196/65044.

DOI:10.2196/65044
PMID:40397936
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12138299/
Abstract

BACKGROUND

Patients with post-COVID-19 condition (PCC) experience persistent, long-term health consequences following SARS-CoV-2 infection, including fatigue, hyperventilation, cognitive impairment, and limitations in daily activities. There is emerging evidence suggesting that exercise and respiratory therapy-based telerehabilitation is safe and could potentially improve physical capacity while reducing health care costs.

OBJECTIVE

This study aims to evaluate the superiority of a multimodal, symptom-titrated telerehabilitation program over standard care in patients with PCC who are severely affected, using the highest oxygen uptake rate (VO [mL/min/kg]) achieved during the cardiopulmonary exercise test (CPET) and minute ventilation/carbon dioxide production slope (VE/VCO [full slope]) as primary outcomes. In addition, this study seeks to provide novel insights into the clinical and physiological adaptations associated with PCC, informing future rehabilitation strategies.

METHODS

This prospective, randomized, waitlist-controlled trial was approved by the Rhineland-Palatinate Medical Association ethics committee. All procedures comply with the Declaration of Helsinki. This study comprises 3 examination time points, which include patient-reported outcomes, clinical assessments, and a CPET. It is structured into an 8-week intervention phase followed by an 8-week follow-up phase. Following baseline assessment, patients will be randomly assigned to either the intervention group (IG) or the control group (CG). During the intervention phase, IG participants will receive a web-based, multimodal, symptom-titrated telerehabilitation program consisting of sports medicine consultations, weekly teleconsultations, a structured pacing approach, and exercise and respiratory therapy. In contrast, CG participants will receive treatment as usual, which includes a single sports medicine consultation on healthy habits and a self-directed pacing approach for managing symptoms and daily activities. During the follow-up phase, IG participants will continue training independently without teleconsultations, whereas CG participants will undergo the same telerehabilitation intervention as the IG. A follow-up assessment will be conducted for both groups to evaluate long-term effects. This study adheres to the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidelines and follows the Consensus on Exercise Reporting Template.

RESULTS

Recruitment began in August 2023 and was extended until March 2025. As of March 2025, 80 participants have been recruited, and data analysis is ongoing. Final results are expected by December 2025, with a cross-sectional analysis of baseline data anticipated by July 2025.

CONCLUSIONS

This study is the first randomized controlled trial investigating the effectiveness of multimodal and symptom-titrated telerehabilitation in patients with PCC who are severely affected. The integration of various objective diagnostic systems will provide valuable insights into emerging postviral fatigue syndromes, supporting the development of CPET-based diagnostics, personalized rehabilitation strategies, and future research on long-term telerehabilitation effectiveness. The findings will be disseminated through peer-reviewed publications, professional networks, and patient advocacy groups to ensure scientific, clinical, and public impact.

TRIAL REGISTRATION

German Clinical Trials Register (DRKS) DRKS00032394; https://drks.de/search/de/trial/DRKS00032394.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/65044.

摘要

背景

新冠后状况(PCC)患者在感染严重急性呼吸综合征冠状病毒2(SARS-CoV-2)后会经历持续的长期健康后果,包括疲劳、换气过度、认知障碍和日常活动受限。越来越多的证据表明,基于运动和呼吸治疗的远程康复是安全的,可能会提高身体能力,同时降低医疗成本。

目的

本研究旨在评估多模式、症状滴定远程康复计划相对于标准护理对受严重影响的PCC患者的优越性,将心肺运动试验(CPET)期间达到的最高摄氧率(VO[毫升/分钟/千克])和分钟通气量/二氧化碳产生斜率(VE/VCO[全斜率])作为主要结局。此外,本研究旨在为与PCC相关的临床和生理适应提供新的见解,为未来的康复策略提供参考。

方法

这项前瞻性、随机、等待名单对照试验已获得莱茵兰-普法尔茨州医学协会伦理委员会的批准。所有程序均符合《赫尔辛基宣言》。本研究包括3个检查时间点,包括患者报告的结局、临床评估和CPET。研究分为一个为期8周的干预阶段,随后是一个为期8周的随访阶段。在基线评估后,患者将被随机分配到干预组(IG)或对照组(CG)。在干预阶段,IG参与者将接受基于网络的多模式、症状滴定远程康复计划,包括运动医学咨询、每周远程会诊、结构化的节奏方法以及运动和呼吸治疗。相比之下,CG参与者将接受常规治疗,包括关于健康习惯的单次运动医学咨询以及用于管理症状和日常活动的自我节奏方法。在随访阶段,IG参与者将在没有远程会诊的情况下继续独立训练,而CG参与者将接受与IG相同的远程康复干预。将对两组进行随访评估以评估长期效果。本研究遵循SPIRIT(标准方案项目:干预试验建议)指南,并遵循运动报告模板共识。

结果

招募工作于2023年8月开始,并延长至2025年3月。截至2025年3月,已招募80名参与者,数据分析正在进行中。预计最终结果将于2025年12月得出,预计2025年7月对基线数据进行横断面分析。

结论

本研究是第一项调查多模式和症状滴定远程康复对受严重影响的PCC患者有效性的随机对照试验。各种客观诊断系统的整合将为新出现的病毒后疲劳综合征提供有价值的见解,支持基于CPET的诊断、个性化康复策略的发展以及未来关于长期远程康复有效性的研究。研究结果将通过同行评审出版物、专业网络和患者倡导团体进行传播,以确保产生科学、临床和公共影响。

试验注册

德国临床试验注册中心(DRKS)DRKS00032394;https://drks.de/search/de/trial/DRKS00032394。

国际注册报告标识符(IRRID):DERR1-10.2196/65044。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7732/12138299/f99d7ab27f51/resprot_v14i1e65044_fig6.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7732/12138299/f43ea25be901/resprot_v14i1e65044_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7732/12138299/eb2732b65547/resprot_v14i1e65044_fig2.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7732/12138299/253a14b0fc42/resprot_v14i1e65044_fig5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7732/12138299/f99d7ab27f51/resprot_v14i1e65044_fig6.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7732/12138299/f43ea25be901/resprot_v14i1e65044_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7732/12138299/eb2732b65547/resprot_v14i1e65044_fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7732/12138299/e589f2dc493e/resprot_v14i1e65044_fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7732/12138299/6b87cbbe74a2/resprot_v14i1e65044_fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7732/12138299/253a14b0fc42/resprot_v14i1e65044_fig5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7732/12138299/f99d7ab27f51/resprot_v14i1e65044_fig6.jpg

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