COVID-19NCT05242094
Pulmonary Rehabilitation Implemented With VR for Post-COVID-19 Patients
A study testing Pulmonary Rehabilitation Program in people with COVID-19, run by The Opole University of Technology at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Pulmonary Rehabilitation Program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2021to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals hospitalized for COVID-19.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
MSWiA Specialist Hospital in Głuchołazy
Głuchołazy, Opole Voivodeship, 48-340
Sebastian Rutkowski, PhD, +48 507027792, s.rutkowski@po.opole.pl
Sebastian Rutkowski, PhD, +48774498000, s.rutkowski@po.opole.pl
About this study
Official title: Assessment of Depressive and Anxiety Symptoms in Post-COVID-19 Patients During In-Hospital Pulmonary Reha-bilitation With Support of Virtual Reality
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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- Pulmonary Rehabilitation Program
- Keywords
- COVID-19, Pulmonary rehabilitation, Virtual Reality
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary Rehabilitation ProgramProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Traditional Pulmonary Rehabilitation Receives: Procedure: Pulmonary Rehabilitation Program |
| Group 2 | Experimental | Pulmonary Rehabilitation in Virtual Reality Receives: Procedure: Pulmonary Rehabilitation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 minutes
Functional Capacity
Functional capacity assessment included exercise capacity (6-minute walk test) and lung ventilation function (spirometry).
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start1 Jan 2021
- Primary completion2 Feb 2021
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Opole University of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05242094
- Sponsor's protocol ID
- COVID_1
- Status last verified
- Feb 2022
- First submitted
- 15 Feb 2022
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be available.
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Depressive and Anxiety Symptoms in Post-COVID-19 Patients During In-Hospital Pulmonary Reha-bilitation With Support of Virtual Reality
- ClinicalTrials.gov ID
- NCT05242094
- Acronym / sponsor ID
- COVID_1
- Conditions
- COVID-19
- Keywords
- COVID-19, Pulmonary rehabilitation, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- The Opole University of TechnologyUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 2 Feb 2021 (actual)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 16 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Procedure: Pulmonary Rehabilitation ProgramTraditional Pulmonary Rehabilitation |
| Group 2 | Experimental | Procedure: Pulmonary Rehabilitation ProgramPulmonary Rehabilitation in Virtual Reality |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals hospitalized for COVID-19.
Key exclusion criteria (8 listed)
- Failure to consent to participate in research,
- pneumonia,
- evidence of ischemic heart disease/acute changes on ECG,
- uncontrolled hypertension,
- insulin dependent diabetes mellitus,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary Rehabilitation ProgramAn 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. | Procedure or surgery | Group 1, Group 2 |
Primary outcome
Hospital Anxiety and Depression Scale
Time frame: 10 minutes
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
Time frame: 20 minutes
Functional capacity assessment included exercise capacity (6-minute walk test) and lung ventilation function (spirometry).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- Individual participant dataSharing planned: No. Data will not be available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary Rehabilitation Program in people with COVID-19, run by The Opole University of Technology at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sebastian Rutkowski, PhD (+48 77 449 8326, s.rutkowski@po.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Anxiety and Depression Scale (time frame: 10 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2022.