Pulmonary Rehabilitation Implemented With Virtual Reality for Post-COVID-19 Patients

The Opole University of Technology

Status: Enrolling

Conditions: COVID-19

Treatments: Procedure: Pulmonary rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT05244135

COVID_2

Details and patient eligibility

About

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.

Full 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?

Enrollment: 66 estimated patients

Sex: All

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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66 participants in 2 patient groups

Pulmonary rehabilitation in VR (VR group)

Experimental group

Description:

The VR group will perform the endurance exercise training using the "Virtual Park", developed by CNR-STIIMA. The system includes a COSMED cycle-ergometer, a virtual environment and a physiological sensor-either a HR band or a pulse-oximeter depending on the target patient's needs. The virtual environment represents a ride in a park, enriched with realistic elements and sound effects, in order to simulate a daily life situation. In the VR group, the VR Tier One device (Stolgraf®) will be used as a VR source. Thanks to using a head mounted display and the phenomenon of total immersion, VR therapy provides an intense visual, auditory and kinaesthetic stimulation. The aim of the software was to calm and improve the mood, while motivating and cognitively activating the patient.

Treatment:

Procedure: Pulmonary rehabilitation

Traditional Pulmonary Rehabilitation (TPR)

Active Comparator group

Description:

In the TPR group, exercise training will be performed on the bicycle. The training will be conducted on cycle ergometers with the use of the Peloton™ system, which ensures the monitoring of performance parameters. In the TPR group, Schultz Autogenous Training will be performed. Schultz Autogenic Training has been shown to be effective in treating these pathologies. In both groups the relaxation training will be carried out once a day and will last about 20 minutes.

Treatment:

Procedure: Pulmonary rehabilitation