NCT05242094

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for not_applicable covid19

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 1, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2021

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 15, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 16, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

March 4, 2022

Status Verified

February 1, 2022

Enrollment Period

1 month

First QC Date

February 15, 2022

Last Update Submit

February 16, 2022

Conditions

Keywords

COVID-19Pulmonary rehabilitationVirtual Reality

Outcome Measures

Primary Outcomes (2)

  • 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.

    10 minutes

  • Functional Capacity

    Functional capacity assessment included exercise capacity (6-minute walk test) and lung ventilation function (spirometry).

    20 minutes

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Traditional Pulmonary Rehabilitation

Procedure: Pulmonary Rehabilitation Program

Group 2

EXPERIMENTAL

Pulmonary Rehabilitation in Virtual Reality

Procedure: Pulmonary Rehabilitation Program

Interventions

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 1Group 2

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals hospitalized for COVID-19.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MSWiA Specialist Hospital in Głuchołazy

Głuchołazy, Opole Voivodeship, 48-340, Poland

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Sebastian Rutkowski, PhD

CONTACT

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 16, 2022

Study Start

January 1, 2021

Primary Completion

February 2, 2021

Study Completion

September 1, 2022

Last Updated

March 4, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Data will not be available.

Locations