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

NCT ID: NCT05244135

Last Updated: 2022-07-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-28
• Study Completion Date: 2022-09-30

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?

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Pulmonary rehabilitation in VR (VR group)

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.

Group Type: EXPERIMENTAL

Pulmonary rehabilitation

Intervention Type: PROCEDURE

An in-patients 3-week high intensity rehabilitation program, five times a week, was used as the intervention treatment. A holistic pulmonary rehabilitation program for SARS-CoV-2 patients with combined treatment focused on increasing exercise capacity, restoring lung function, and supporting mental health, developed by a multidisciplinary team, was introduced. Rehabilitation program includes exercise capacity training on a cycle ergometer, breathing exercises, general fitness exercises, resistance training, and relaxation.

Traditional Pulmonary Rehabilitation (TPR)

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.

Group Type: ACTIVE_COMPARATOR

Pulmonary rehabilitation

Intervention Type: PROCEDURE

An in-patients 3-week high intensity rehabilitation program, five times a week, was used as the intervention treatment. A holistic pulmonary rehabilitation program for SARS-CoV-2 patients with combined treatment focused on increasing exercise capacity, restoring lung function, and supporting mental health, developed by a multidisciplinary team, was introduced. Rehabilitation program includes exercise capacity training on a cycle ergometer, breathing exercises, general fitness exercises, resistance training, and relaxation.

Interventions

Pulmonary rehabilitation

An in-patients 3-week high intensity rehabilitation program, five times a week, was used as the intervention treatment. A holistic pulmonary rehabilitation program for SARS-CoV-2 patients with combined treatment focused on increasing exercise capacity, restoring lung function, and supporting mental health, developed by a multidisciplinary team, was introduced. Rehabilitation program includes exercise capacity training on a cycle ergometer, breathing exercises, general fitness exercises, resistance training, and relaxation.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Opole University of Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

MSWiA Specialist Hospital in Głuchołazy

Głuchołazy, Opole Voivodeship, Poland

Site Status: RECRUITING

Countries

Poland

Central Contacts

Sebastian Rutkowski, PhD

Role: CONTACT

s.rutkowski@po.edu.pl

+48 77 449 8326

Facility Contacts

Sebastian Rutkowski, PhD

Role: primary

s.rutkowski@po.opole.pl

+48 507027792

Sebastian Rutkowski, PhD

Role: backup

s.rutkowski@po.opole.pl

+48774498000

References

Rutkowski S, Bogacz K, Czech O, Rutkowska A, Szczegielniak J. Effectiveness of an Inpatient Virtual Reality-Based Pulmonary Rehabilitation Program among COVID-19 Patients on Symptoms of Anxiety, Depression and Quality of Life: Preliminary Results from a Randomized Controlled Trial. Int J Environ Res Public Health. 2022 Dec 17;19(24):16980. doi: 10.3390/ijerph192416980.

Reference Type: DERIVED

PMID: 36554860 (View on PubMed)

Other Identifiers

COVID_2

Identifier Type: -

Identifier Source: org_study_id