Valutazione Degli Esiti a Medio-lungo Termine Della Sindrome Long Covid in Pazienti Trattati Con un Protocollo di Riabilitazione in Ambiente Termale o in Teleriabilitazione

Padua University General Hospital2 个研究点分布在 1 个国家目标入组 72 人开始时间: 2023年1月1日最近更新: 2024年4月23日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 72
试验地点: 2
主要终点: Fatigue Assessment Scale

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Objective: This study aimed to evaluate the effectiveness of a multisystem rehabilitation program for Long Covid patients in two different settings.

Design: Randomized controlled trial. Settings: Health resort and home-based. Participants: 72 Long Covid patients. Interventions: Patients were randomly assigned into two groups: Group A (n=36) received health resort intervention, and Group B (n=36) received home-based care. Both groups underwent a 5-week rehabilitation program, involving motor, respiratory, and cognitive exercises, two sessions per week.

Outcomes: Assessments were conducted before (T0) and after treatment (T1), at 3 (T2) and 6 months (T3), including respiratory and physical function, handgrip strength, fatigue, pain, quality of life, psychological function, and satisfaction.

详细描述

At the outpatient clinics of the Neurorehabilitation Unit of the University Hospital of Padua, 103 patients were initially assessed. Out of these patients, 72 subjects of both genders with medium-to-long-term outcomes following previous infection with the SARS-CoV-2 virus were recruited for this study. Eight patients were excluded from the study due to initial assessments revealing conditions falling under exclusion criteria (1 patient lacked a prior diagnosis with a COVID-19 infection swab, 2 had concurrent tumor pathologies, 3 exhibited systemic inflammation, and 2 had skin infections), and 23 patients chose to undergo a rehabilitation program at a rehabilitative gym instead. Participants were randomly assigned to one of two rehabilitation treatment groups: the group treated at a health resort facility (Group A, n=36) and the group performing the exercise program at home (Group B, n=36). However, 6 patients did not complete follow-up assessments at different time points, resulting in the final evaluation of data collected from 66 patients, with 33 allocated to Group A and 33 to Group B (Fig. 1).

The patient enrollment was conducted between January 2023 and April 2023. Patients in group A underwent a 5-week rehabilitation cycle with two weekly sessions, totaling 10 sessions, in a health resort setting. The patients underwent treatments at two health resort facilities located in the Euganean Basin, Veneto, Italy, equipped with pools of the same depth, size, and water type. Patients in group B underwent a 5-week rehabilitation cycle at home with two weekly sessions, totaling 10 sessions.

At the beginning (T0) and at the end (T1) of the treatment, and during two subsequent follow-up times at 3 months (T2) and 6 months (T3), after the end of the treatment, patients in both groups were evaluated.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Single Group
主要目的: Treatment
盲法: Single (Investigator)

入排标准

年龄范围: 18 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•The inclusion criteria for the study included the following requirements: age between 18 and 75 years; a previous COVID-19 infection occurring between 6 and 18 months before our initial assessment; negative results in tests for the nucleic acid of the SARS-CoV-2 virus conducted on respiratory samples, such as oropharyngeal swabs; body temperature ≤ 37°C; presence of reduced cardio-respiratory capacity and/or motor deficits caused by the SARS-CoV-2 virus infection; manifestation of possible cognitive symptoms that could not be attributed to other conditions; no participation in cycles of thermal mineral-rich therapy in the six months preceding the study.

排除标准

•from the study included: inability to understand and sign the informed consent form; absence of a previous positive detection of nucleic acid of the SARS-CoV-2 virus in tests on respiratory samples; current positivity for the nucleic acid of the SARS-CoV-2 virus in respiratory samples; epilepsy, severe psychiatric disorders, neoplasms, or pregnancy. Moreover, commonly recognized contraindications for health resort treatments, such as skin infections or open wounds, systemic inflammation, heart, liver, respiratory, or kidney failure, and urinary or fecal incontinence, were considered additional exclusion criteria.