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

Primary Purpose

COVID-19

Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Pulmonary rehabilitation
Sponsored by
The Opole University of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, Pulmonary rehabilitation, Virtual Reality

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • MSWiA Specialist Hospital in GłuchołazyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pulmonary rehabilitation in VR (VR group)

Traditional Pulmonary Rehabilitation (TPR)

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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
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
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.
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

Secondary Outcome Measures

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
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)

Full Information

First Posted
February 15, 2022
Last Updated
July 12, 2022
Sponsor
The Opole University of Technology
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1. Study Identification

Unique Protocol Identification Number
NCT05244135
Brief Title
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2022 (Actual)
Primary Completion Date
March 21, 2022 (Actual)
Study Completion Date
September 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Opole University of Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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? Whether participation in the 3-week pulmonary rehabilitation programme will change the mental condition of individuals after infection with SARS-CoV-2 ? 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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19, Pulmonary rehabilitation, Virtual Reality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pulmonary rehabilitation in VR (VR group)
Arm Type
Experimental
Arm 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.
Arm Title
Traditional Pulmonary Rehabilitation (TPR)
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Pulmonary rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Lung function
Description
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.
Time Frame
10 minutes
Title
Dyspnea
Description
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
Time Frame
2 minutes
Title
Stress
Description
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
Time Frame
5 minutes
Title
Anxiety and depression
Description
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.
Time Frame
5 minutes
Title
Individual's perception of quality of life
Description
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
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Heart Rate Variability
Description
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
Time Frame
30 minutes
Title
Impact of technology
Description
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)
Time Frame
10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sebastian Rutkowski, PhD
Phone
+48 77 449 8326
Email
s.rutkowski@po.edu.pl
Facility Information:
Facility Name
MSWiA Specialist Hospital in Głuchołazy
City
Głuchołazy
State/Province
Opole
ZIP/Postal Code
48-340
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sebastian Rutkowski, PhD
Phone
+48 507027792
Email
s.rutkowski@po.opole.pl
First Name & Middle Initial & Last Name & Degree
Sebastian Rutkowski, PhD
Phone
+48774498000
Email
s.rutkowski@po.opole.pl
First Name & Middle Initial & Last Name & Degree
Jan Szczegielniak, Prof, PhD
First Name & Middle Initial & Last Name & Degree
Katarzyna Bogacz, PhD
First Name & Middle Initial & Last Name & Degree
Mirosław Lenczuk, MSc
First Name & Middle Initial & Last Name & Degree
Sebastian Rutkowski, PhD
First Name & Middle Initial & Last Name & Degree
Anna Rutkowska, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Undecided

Learn more about this trial

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

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