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

COVID-19 Clinical Trial

Official title:

Implementation of an Innovative Hospital Pulmonary Rehabilitation Based on Virtual Reality for Post-COVID-19 Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05244135
• Other study ID #: COVID_2
• Status: Recruiting
• Phase: N/A
• Start date: February 28, 2022
• Est. completion date: September 30, 2022

Study information

• Verified date: July 2022
• Source: The Opole University of Technology
• Contact: Sebastian Rutkowski, PhD
• Phone: +48 77 449 8326
• Email: s.rutkowski[@]po.edu.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: September 30, 2022
• Est. primary completion date: March 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Poland	MSWiA Specialist Hospital in Glucholazy	Glucholazy	Opole

Sponsors (1)

Lead Sponsor	Collaborator
The Opole University of Technology

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung function	Spirometry testing will be performed in all patients before and after rehabilitation. For the assessment of respiratory function, the following indicators will be used: forced vital capacity (FVC), forced expiratory volume in one second (FEV1), and FEV1 percentage obtained the current VC (FEV1%). The measurement will be performed three times by the patient and the best result will be included in the research study.	10 minutes
Primary	Dyspnea	In all patients, prior to and immediately after the 6-minute walk test, an assessment of dyspnoea will be made by the 10-degree Borg scale, which is the most versatile and most widely used scale for breathlessness. This method will allow for comparison of the absolute level of breathlessness patients feel at a given exercise intensity. A lower score means less impairment	2 minutes
Primary	Stress	The Perceived Stress Scale (PSS) is the most widely used psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The scale also includes a number of direct queries about current levels of experienced stress. A lower score means less impairment	5 minutes
Primary	Anxiety and depression	The HADS is a 14-item scale, scoring each item from 0 to 3. The first seven items relate to anxiety (HADS-A), and the remaining seven items relate to depression (HADS-D). The global scoring ranges from 0 to 42, with a cut-off point of 8/21 for anxiety and 8/21 for depression. The higher the score is, the greater the anxiety or depression symptoms. The scale is considered to be a valid research method.	5 minutes
Primary	Individual's perception of quality of life	The WHO Quality of Life-BREF questionnaire is designed to assess the quality of life of healthy and sick people, both for cognitive and clinical purposes. It contains 26 questions analysing four areas of life: physical, psychological, social and environmental. A lower score means a poorer quality of life	10 minutes
Secondary	Heart Rate Variability	During trainings, Polar H10 monitor (Polar Electro Oy Inc., Kempele, Finland) will be employed to record HR series at a sampling frequency of 1000 Hz. The device is recommended as the gold standard for R-R interval assessments during intense activities to obtain HR and HRV. All HRV analyses will be carried out with the Kubios HRV Premium version 3.3.1	30 minutes
Secondary	Impact of technology	The following scales will be used to evaluate immersive VR technology: System Usability (immersive VR group): System Usability Scale (SUS) Cyber illness (immersive VR group): Simulator Sickness Questionnaire (SSQ) Anxiety/negative affect (while using VR): the Positive and Negative Affect Scale (PANAS)	10 minutes