- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05244135
Pulmonary Rehabilitation Implemented With Virtual Reality for Post-COVID-19 Patients
Implementation of an Innovative Hospital Pulmonary Rehabilitation Based on Virtual Reality for Post-COVID-19 Patients
Study Overview
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?
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Opole
-
Głuchołazy, Opole, Poland, 48-340
- Recruiting
- MSWiA Specialist Hospital in Głuchołazy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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. |
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.
|
Active Comparator: 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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lung function
Time Frame: 10 minutes
|
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
|
Dyspnea
Time Frame: 2 minutes
|
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
|
Stress
Time Frame: 5 minutes
|
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
|
Anxiety and depression
Time Frame: 5 minutes
|
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
|
Individual's perception of quality of life
Time Frame: 10 minutes
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart Rate Variability
Time Frame: 30 minutes
|
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
|
Impact of technology
Time Frame: 10 minutes
|
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
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- COVID_2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on COVID-19
-
University of Roma La SapienzaQueen Mary University of London; Università degli studi di Roma Foro Italico; Bios Prevention SrlCompletedPost Acute Sequelae of COVID-19 | Post COVID-19 Condition | Long-COVID | Chronic COVID-19 SyndromeItaly
-
Yang I. PachankisActive, not recruitingCOVID-19 Respiratory Infection | COVID-19 Stress Syndrome | COVID-19 Vaccine Adverse Reaction | COVID-19-Associated Thromboembolism | COVID-19 Post-Intensive Care Syndrome | COVID-19-Associated StrokeChina
-
Massachusetts General HospitalRecruitingPost Acute COVID-19 Syndrome | Long COVID | Post Acute Sequelae of COVID-19 | Long COVID-19United States
-
Indonesia UniversityRecruitingPost-COVID-19 Syndrome | Long COVID | Post COVID-19 Condition | Post-COVID Syndrome | Long COVID-19Indonesia
-
Erasmus Medical CenterDa Vinci Clinic; HGC RijswijkNot yet recruitingPost-COVID-19 Syndrome | Long COVID | Long Covid19 | Post COVID-19 Condition | Post-COVID Syndrome | Post COVID-19 Condition, Unspecified | Post-COVID ConditionNetherlands
-
Dr. Soetomo General HospitalIndonesia-MoH; Universitas Airlangga; Biotis Pharmaceuticals, IndonesiaRecruitingCOVID-19 Pandemic | COVID-19 Vaccines | COVID-19 Virus DiseaseIndonesia
-
University of Witten/HerdeckeInstitut für Rehabilitationsforschung NorderneyCompletedPost-COVID-19 Syndrome | Long-COVID-19 SyndromeGermany
-
Jonathann Kuo, MDActive, not recruitingSARS-CoV2 Infection | Post-COVID-19 Syndrome | Dysautonomia | Post Acute COVID-19 Syndrome | Long COVID | Long Covid19 | COVID-19 Recurrent | Post-Acute COVID-19 | Post-Acute COVID-19 Infection | Post Acute Sequelae of COVID-19 | Dysautonomia Like Disorder | Dysautonomia Orthostatic Hypotension Syndrome | Post... and other conditionsUnited States
-
University Hospital, Ioannina1st Division of Internal Medicine, University Hospital of IoanninaRecruitingCOVID-19 Pneumonia | COVID-19 Respiratory Infection | COVID-19 Pandemic | COVID-19 Acute Respiratory Distress Syndrome | COVID-19-Associated Pneumonia | COVID 19 Associated Coagulopathy | COVID-19 (Coronavirus Disease 2019) | COVID-19-Associated ThromboembolismGreece
Clinical Trials on Pulmonary rehabilitation
-
Faculty of Medicine, SousseCompletedChronic Obstructive Pulmonary DiseaseTunisia
-
Universidade Federal de Santa MariaCompletedChronic Obstructive Pulmonary DiseaseBrazil
-
Istanbul Medipol University HospitalRecruitingLung Diseases | Bronchiectasis | Lung Diseases, Interstitial | Pulmonary RehabilitationTurkey
-
La Trobe UniversityMonash University; The Alfred; Austin HealthCompletedChronic Obstructive Pulmonary DiseaseAustralia
-
Aveiro UniversityCentro Hospitalar do Baixo VougaRecruitingChronic Obstructive Pulmonary Disease | Interstitial Lung DiseasePortugal
-
National Cheng-Kung University HospitalCompletedTelerehabilitation | Pulmonary Rehabilitation | Compliance, Patient | COPD | Cardiopulmonary Exercise TestTaiwan
-
Istanbul Medipol University HospitalCompletedEmphysema | Bronchoscopic Lung Volume Reduction | Hospital-based Pulmonary Rehabilitation | Home-based Pulmonary RehabilitationTurkey
-
Hospital Clinic of BarcelonaSociedad Española de Neumología y Cirugía TorácicaUnknownNon-cystic Fibrosis Bronchiectasis
-
University of MaltaCompletedInterstitial Lung DiseaseMalta
-
Michaël RACODONRecruitingRespiratory DiseasesFrance