Pulmonary Rehabilitation Implemented With VR for Post-COVID-19 Patients

NCT ID: NCT05242094

Last Updated: 2022-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-09-01

Brief Summary

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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

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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

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group 1

Traditional Pulmonary Rehabilitation

Group Type ACTIVE_COMPARATOR

Pulmonary Rehabilitation Program

Intervention Type PROCEDURE

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.

Group 2

Pulmonary Rehabilitation in Virtual Reality

Group Type EXPERIMENTAL

Pulmonary Rehabilitation Program

Intervention Type PROCEDURE

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.

Interventions

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Pulmonary Rehabilitation Program

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Opole University of Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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MSWiA Specialist Hospital in Głuchołazy

Głuchołazy, Opole Voivodeship, Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Sebastian Rutkowski, PhD

Role: CONTACT

+48 77 449 8326

Facility Contacts

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Sebastian Rutkowski, PhD

Role: primary

+48 507027792

Sebastian Rutkowski, PhD

Role: backup

+48774498000

Other Identifiers

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COVID_1

Identifier Type: -

Identifier Source: org_study_id

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