Pulmonary Rehabilitation Implemented With VR for Post-COVID-19 Patients

Not Applicable

• Conditions: COVID-19
• Interventions: Procedure: Pulmonary Rehabilitation Program

• Registration Number: NCT05242094
• Lead Sponsor: The Opole University of Technology

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.

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2021-02-02
• Status Verified: 2022-02
• Study First Submitted: 2022-02-15
• Study First Submitted QC: 2022-02-15
• Study First Posted: 2022-02-16
• Last Update Submitted: 2022-02-16
• Last Update Posted: 2022-03-04
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Pulmonary Rehabilitation Program	Traditional Pulmonary Rehabilitation
Group 2	Pulmonary Rehabilitation Program	Pulmonary Rehabilitation in Virtual Reality

Primary Outcome Measures

Name	Time	Method
Hospital Anxiety and Depression Scale	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	20 minutes	Functional capacity assessment included exercise capacity (6-minute walk test) and lung ventilation function (spirometry).

Trial Locations

Locations (1)

MSWiA Specialist Hospital in Głuchołazy; 🇵🇱 Głuchołazy, Opole, Poland