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

T

The Opole University of Technology

Status

Unknown

Conditions

COVID-19

Treatments

Procedure: Pulmonary Rehabilitation Program

Study type

Interventional

Funder types

Other

Identifiers

NCT05242094
COVID_1

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,000 estimated patients

Sex

All

Ages

30 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

2,000 participants in 2 patient groups

Group 1
Active Comparator group
Description:
Traditional Pulmonary Rehabilitation
Treatment:
Procedure: Pulmonary Rehabilitation Program
Group 2
Experimental group
Description:
Pulmonary Rehabilitation in Virtual Reality
Treatment:
Procedure: Pulmonary Rehabilitation Program

Trial contacts and locations

1

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Central trial contact

Sebastian Rutkowski, PhD

Data sourced from clinicaltrials.gov

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