Clinical trial NCT05244135: Pulmonary Rehabilitation Implemented With Virtual Reality for Post-COVID-19 Patients
Official title: Implementation of an Innovative Hospital Pulmonary Rehabilitation Based on Virtual Reality for Post-COVID-19 Patients
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: 2022-02-17
Enrollment: 66
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Over recent months, SARS-CoV-2 infection has been confirmed in millions of people around the world. 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. 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.

Detailed description: COVID-19 caused by SARS-CoV-2 has led to a global public health crisis. Millions of people around the world are infected with a severe acute respiratory coronavirus, causing COVID-19. Some of the patients with confirmed COVID-19 are admitted to hospital for acute care due to severe respiratory symptoms and coronary artery disease and, in some cases, even acute respiratory symptoms requiring prolonged mechanical ventilation. It is highly anticipated that some patients with COVID-19 will have a need for rehabilitation interventions during and immediately after hospitalization. However, data on safety and efficacy of rehabilitation during and/or after hospitalization in these patients are lacking. The benefits of respiratory rehabilitation are well known and existing programmes can be used as one of the referral paths for the rehabilitation of COVID-19 survivors with symptoms and/or impairment of physical functions. Many scrutinies and systematic literature reviews show the beneficial effect of pulmonary rehabilitation in patients with chronic respiratory diseases on exercise capacity, lung function, respiratory muscle strength, quality of life. Therefore, we assumed that the mechanisms leading to improvement of the psychosomatic condition will be the same as those in COVID-19 survivors because they present with the same clinical symptoms. This project is aimed to propose an innovative comprehensive intervention based on a stationary pulmonary rehabilitation (PR) programme for COVID-19 survivors. In our project, we intend to answer the following questions:

1. Whether participation in the 3-week pulmonary rehabilitation programme will change the pulmonary function and exercise capacity of individuals after infection with SARS-CoV-2?
2. Whether participation in the 3-week pulmonary rehabilitation programme will change the mental condition of individuals after infection with SARS-CoV-2 ?
3. Whether the implementation of immersive VR therapy in a pulmonary rehabilitation programme for post-COVID-19 patients will change the effectiveness compared to the traditional form of rehabilitation?

Eligibility criteria: Inclusion Criteria:

* Women and men aged 40-60 years who were hospitalized for COVID-19.

Exclusion Criteria:

* No consent to participate,
* active pneumonia diagnosed by x-ray,
* documented heart disease (stable or unstable),
* status after CABG, PTCA,
* uncontrolled hypertension,
* insulin-dependent diabetes mellitus,
* inability to exercise independently or musculoskeletal/neurological conditions that would prevent completion of the course,
* lung cancer,
* cognitive impairment or Mini-Mental State Examination \< 24.

Primary outcomes:
measure: Lung function
timeFrame: 10 minutes
measure: Dyspnea
timeFrame: 2 minutes
measure: Stress
timeFrame: 5 minutes
measure: Anxiety and depression
timeFrame: 5 minutes
measure: Individual's perception of quality of life
timeFrame: 10 minutes
Secondary outcomes:
measure: Heart Rate Variability
timeFrame: 30 minutes
measure: Impact of technology
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Głuchołazy
country: Poland
facility: MSWiA Specialist Hospital in Głuchołazy
state: Opole
Study officials:
References: