Roggeman Stijn, Jimenez Garcia Berenice Gabriela, Leemans Lynn, Demol Joy, Geers Janne, De Smedt Ann, Putman Koen, Schiltz Marc, Beckwée David, De Waele Elisabeth
Department of Physical Medicine and Rehabilitation, Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan, 101, 1090, Brussels, Belgium.
Department of Clinical Nutrition and Dietetics, Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan, 101, 1090, Brussels, Belgium.
Pilot Feasibility Stud. 2023 Sep 28;9(1):166. doi: 10.1186/s40814-023-01392-1.
Long COVID is suggested to be present in 14 to 43% of COVID 19-survivors. Literature on this new condition states a need for a multidisciplinary approach including physical exercise and nutrition. The aim of the current pilot study is to investigate the feasibility of the proposed protocol to prepare for a randomized controlled study that addresses the effectiveness of a personalized multimodal treatment compared to standard physiotherapy.
This is a protocol of the UNLOCK (Nutrition and LOComotoric rehabilitation in long COVID) study, a pragmatic, single center, randomized controlled pilot trial with two groups. Patients with persisting symptoms related to a SARS-CoV-2 infection will receive either standard physiotherapy or a personalized multimodal treatment for a period of 12 weeks, consisting of individualized physical exercise program combined with individualized nutritional therapy. They will be followed-up at 6, 12, and 18 weeks after randomization.
A multidisciplinary approach for dealing with long COVID is needed. Because of the lack of clear data and the fact that this is a very heterogenic group, we aim to prepare and optimize a randomized controlled study that addresses the effectiveness of a personalized multimodal treatment.
ClinicalTrials.gov Identifier: NCT05254301 (since February 24, 2022).
据推测,14%至43%的新冠病毒感染者康复后会出现长期新冠症状。关于这种新情况的文献表明,需要采取多学科方法,包括体育锻炼和营养。本初步研究的目的是调查所提议方案的可行性,为一项随机对照研究做准备,该研究将比较个性化多模式治疗与标准物理治疗的效果。
这是“解锁(长期新冠中的营养与运动康复)”研究的方案,是一项务实的单中心随机对照初步试验,分为两组。有与新冠病毒感染相关持续症状的患者将接受为期12周的标准物理治疗或个性化多模式治疗,后者包括个性化体育锻炼计划和个性化营养治疗。随机分组后,将在第6、12和18周对他们进行随访。
应对长期新冠需要采取多学科方法。由于缺乏明确数据,且这是一个非常异质性的群体,我们旨在准备并优化一项随机对照研究,以探讨个性化多模式治疗的效果。
ClinicalTrials.gov标识符:NCT(自2022年2月24日起)05254301 。