Pulmonary Rehabilitation Implemented With VR for Post-COVID-19 Patients
Primary Purpose
COVID-19
Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Pulmonary Rehabilitation Program
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, Pulmonary rehabilitation, Virtual Reality
Eligibility Criteria
Inclusion Criteria:
- Individuals hospitalized for COVID-19.
Exclusion Criteria:
- Failure to consent to participate in research,
- pneumonia,
- evidence of ischemic heart disease/acute changes on ECG,
- uncontrolled hypertension,
- insulin dependent diabetes mellitus,
- inability to exercise independently or musculoskeletal/neurological conditions that would prevent completion of the course,
- lung cancer,
- cognitive disorders, or Mini-Mental State Examination < 24.
Sites / Locations
- MSWiA Specialist Hospital in GłuchołazyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Group 1
Group 2
Arm Description
Traditional Pulmonary Rehabilitation
Pulmonary Rehabilitation in Virtual Reality
Outcomes
Primary Outcome Measures
Hospital Anxiety and Depression Scale
The Polish version of the Hospital Anxiety and Depression Scale (HADS) was used to assess depression and anxiety in patients. The questionnaire is considered a reliable method of assessing anxiety and depression [15]. The HADS questionnaire consists of 14 questions scored on a 4-point (0 to 3) scale.
Functional Capacity
Functional capacity assessment included exercise capacity (6-minute walk test) and lung ventilation function (spirometry).
Secondary Outcome Measures
Full Information
NCT ID
NCT05242094
First Posted
February 15, 2022
Last Updated
February 16, 2022
Sponsor
The Opole University of Technology
1. Study Identification
Unique Protocol Identification Number
NCT05242094
Brief Title
Pulmonary Rehabilitation Implemented With VR for Post-COVID-19 Patients
Official Title
Assessment of Depressive and Anxiety Symptoms in Post-COVID-19 Patients During In-Hospital Pulmonary Reha-bilitation With Support of Virtual Reality
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
February 2, 2021 (Actual)
Study Completion Date
September 1, 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
Although the COVID-19 pandemic was announced almost 2 years ago, societies are still facing the effects not only of individuals but also of entire populations. Clinical symptoms in patients depending on the variant of the virus range from fever, sore throat, cough, fatigue, or gastrointestinal or neurological symptoms. Symptoms of respiratory failure also occur, as well as heart and kidney damage. Therefore, it is important to implement appropriate pulmonary rehabilitation programs to counteract the effects of the disease. The current project aims to evaluate the effectiveness of a comprehensive pulmonary rehabilitation program for patients hospitalized for SARS-CoV2 infection.
Detailed Description
Initial studies indicated that approximately 60 days after the first COVID-19 symptom onset, only 13% of patients previously hospitalized for COVID-19 were reported to be essentially free of any COVID-19-related symptoms, while 32% had one or two symptoms and 55% had three or more symptoms. 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. In the confrontation of such an uncertain prognosis, it seems justified to introduce preventive actions against the development of pandemic-related adverse effects. To date, only few publications assessed the effectiveness of early post-hospital rehabilitation of patients with COVID-19. 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.
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
2000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Traditional Pulmonary Rehabilitation
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Pulmonary Rehabilitation in Virtual Reality
Intervention Type
Procedure
Intervention Name(s)
Pulmonary Rehabilitation Program
Intervention Description
An in-patients 3-week high intensity rehabilitation program, five times a week, was used as the intervention treatment. The author's pulmonary rehabilitation program was programmed based on previous experience in patients with COPD. A holistic pulmonary rehabilitation program with combined treatment focused on increasing exercise capacity, restoring lung function, and supporting mental health, developed by a multidisciplinary team, was introduced. Based on the patient's submaximal exercise tolerance test results, the qualification for one of the respiratory physiotherapy models differing in therapy intensity was performed. Rehabilitation models included exercise capacity training on a cycle ergometer, breathing exercises, general fitness exercises, resistance training, and relaxation.
Primary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale
Description
The Polish version of the Hospital Anxiety and Depression Scale (HADS) was used to assess depression and anxiety in patients. The questionnaire is considered a reliable method of assessing anxiety and depression [15]. The HADS questionnaire consists of 14 questions scored on a 4-point (0 to 3) scale.
Time Frame
10 minutes
Title
Functional Capacity
Description
Functional capacity assessment included exercise capacity (6-minute walk test) and lung ventilation function (spirometry).
Time Frame
20 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Individuals hospitalized for COVID-19.
Exclusion Criteria:
Failure to consent to participate in research,
pneumonia,
evidence of ischemic heart disease/acute changes on ECG,
uncontrolled hypertension,
insulin dependent diabetes mellitus,
inability to exercise independently or musculoskeletal/neurological conditions that would prevent completion of the course,
lung cancer,
cognitive disorders, 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
No
IPD Sharing Plan Description
Data will not be available.
Learn more about this trial
Pulmonary Rehabilitation Implemented With VR for Post-COVID-19 Patients
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