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临床试验/NCT05242094
NCT05242094Unknown不适用

Assessment of Depressive and Anxiety Symptoms in Post-COVID-19 Patients During In-Hospital Pulmonary Reha-bilitation With Support of Virtual Reality

The Opole University of Technology2 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
2,000
试验地点
2
主要终点
Hospital Anxiety and Depression Scale

研究概览

简要总结

Although the COVID-19 pandemic was announced almost 2 years ago, societies are still facing the effects not only of individuals but also of entire populations. Clinical symptoms in patients depending on the variant of the virus range from fever, sore throat, cough, fatigue, or gastrointestinal or neurological symptoms. Symptoms of respiratory failure also occur, as well as heart and kidney damage. Therefore, it is important to implement appropriate pulmonary rehabilitation programs to counteract the effects of the disease. The current project aims to evaluate the effectiveness of a comprehensive pulmonary rehabilitation program for patients hospitalized for SARS-CoV2 infection.

详细描述

Initial studies indicated that approximately 60 days after the first COVID-19 symptom onset, only 13% of patients previously hospitalized for COVID-19 were reported to be essentially free of any COVID-19-related symptoms, while 32% had one or two symptoms and 55% had three or more symptoms. Furthermore, the COVID-19 pandemic gives rise to new psychosocial and emotional stressors for recovering patients, including social isolation, physical distancing, loss of employment and uncertainties about the future. In the confrontation of such an uncertain prognosis, it seems justified to introduce preventive actions against the development of pandemic-related adverse effects. To date, only few publications assessed the effectiveness of early post-hospital rehabilitation of patients with COVID-19. This project is aimed to propose an innovative comprehensive intervention based on a stationary pulmonary rehabilitation (PR) programme for COVID-19 survivors. Moreover, this project assumes the use of virtual reality (VR) in rehabilitation processes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
30 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals hospitalized for COVID-19.

排除标准

  • Failure to consent to participate in research,
  • pneumonia,
  • evidence of ischemic heart disease/acute changes on ECG,
  • uncontrolled hypertension,
  • insulin dependent diabetes mellitus,
  • inability to exercise independently or musculoskeletal/neurological conditions that would prevent completion of the course,
  • lung cancer,
  • cognitive disorders, or Mini-Mental State Examination < 24.

结局指标

主要结局

Hospital Anxiety and Depression Scale

时间窗: 10 minutes

The Polish version of the Hospital Anxiety and Depression Scale (HADS) was used to assess depression and anxiety in patients. The questionnaire is considered a reliable method of assessing anxiety and depression \[15\]. The HADS questionnaire consists of 14 questions scored on a 4-point (0 to 3) scale.

Functional Capacity

时间窗: 20 minutes

Functional capacity assessment included exercise capacity (6-minute walk test) and lung ventilation function (spirometry).

次要结局

未报告次要终点

研究者

发起方
The Opole University of Technology
申办方类型
Other
责任方
Sponsor

研究点 (2)

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