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
1 other identifier
interventional
66
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable covid19
Started Feb 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 15, 2022
CompletedFirst Posted
Study publicly available on registry
February 17, 2022
CompletedStudy Start
First participant enrolled
February 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 21, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2022
CompletedJuly 13, 2022
July 1, 2022
21 days
February 15, 2022
July 12, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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
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
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
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
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 Outcomes (2)
Heart Rate Variability
30 minutes
Impact of technology
10 minutes
Study Arms (2)
Pulmonary rehabilitation in VR (VR group)
EXPERIMENTALThe 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.
Traditional Pulmonary Rehabilitation (TPR)
ACTIVE COMPARATORIn 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Women and men aged 40-60 years who were hospitalized for COVID-19.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
MSWiA Specialist Hospital in Głuchołazy
Głuchołazy, Opole Voivodeship, 48-340, Poland
Related Publications (1)
Rutkowski S, Bogacz K, Czech O, Rutkowska A, Szczegielniak J. Effectiveness of an Inpatient Virtual Reality-Based Pulmonary Rehabilitation Program among COVID-19 Patients on Symptoms of Anxiety, Depression and Quality of Life: Preliminary Results from a Randomized Controlled Trial. Int J Environ Res Public Health. 2022 Dec 17;19(24):16980. doi: 10.3390/ijerph192416980.
PMID: 36554860DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2022
First Posted
February 17, 2022
Study Start
February 28, 2022
Primary Completion
March 21, 2022
Study Completion
September 30, 2022
Last Updated
July 13, 2022
Record last verified: 2022-07