Clinical trial NCT05242094: Pulmonary Rehabilitation Implemented With VR for Post-COVID-19 Patients
Official title: Assessment of Depressive and Anxiety Symptoms in Post-COVID-19 Patients During In-Hospital Pulmonary Reha-bilitation With Support of Virtual Reality
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Keywords: COVID-19
Pulmonary rehabilitation
Virtual Reality
Lead sponsor: The Opole University of Technology
Sponsor class: OTHER
First posted: 2022-02-16
Enrollment: 2000
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Individuals hospitalized for COVID-19.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Hospital Anxiety and Depression Scale
timeFrame: 10 minutes
measure: Functional Capacity
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Głuchołazy
country: Poland
facility: MSWiA Specialist Hospital in Głuchołazy
state: Opole
Study officials:
References: