- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05619666
Acute Rehabilitation in Patients With COVID-19 Pneumonia
November 15, 2022 updated by: Tamara Filipovic, Institut za Rehabilitaciju Sokobanjska Beograd
Acute Rehabilitation in Patients With COVID-19 Pneumonia a Single Center Experience From a Developing Country
COVID-19 can have different clinical manifestations including myalgia, arthralgia, neurological, cardiac, psychological and other manifestations.These patients are at greater risk of developing consequences of prolonged bed rest.
Therefore physical medicine and rehabilitation could have an important role in the multidisciplinary treatment of these issues.
Early respiratory and neuromuscular rehabilitation is necessary to improve functional physical limitations, performance, muscle strength, endurance as well as cognitive and emotional domains.
Some studies proposed that rehabilitation protocols in the inpatient setting include early mobilisation, strength and endurance training with the aim of reducing weakness and dependency.
This Study aimed to detect the effects of rehabilitation in patients with Covid-19 who were admitted in temporary Covid hospital in Serbia.
Furthermore, to emphasize the importance of functional assessment of the patients, in identifying their problems and selections of priorities in planning the best therapeutic protocol.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Belgrade, Serbia, 11000
- Recruiting
- Tamara Filipovic
-
Contact:
- Tamara Filipovic
- Phone Number: +381652832505
- Email: tamarabackovic@gmail.com
-
Contact:
- Milica Lazovic
- Phone Number: +38163410058
- Email: MilicaLazovic15@gmail.com
-
Belgrade, Serbia
- Recruiting
- Institute for Rehabilitation
-
Contact:
- Tamara Filipovic, Phd
- Phone Number: 381652832505
- Email: tamarabackovic@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 95 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Positive pharyngeal or nasal swab for SARS CoV-2, 3) SP O2> 94% on admission, 4) body temperature under 37.5 5) Clinical stability defined by ability to perform bedside active mobilization without a reduction of oxygen saturation (SpO2) below 92%;
Exclusion Criteria:
- 1) SP o2 < 94% on admission, 2) Moderate and severe heart failure (grade III and IV, NY heart Association), 3) Paresis or plegia as a result of CVI or neurodegenerative disease, 4) Impaired cognitive status.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Severity of COVID-19 infection
Based on the severity of Covid-19 infection patients were divided into 2 groups: First group (MMG) mild to moderate group and second group (SSG) stable severe group.
|
Patients included in the study started the rehabilitation program when they were hemodynamic stable, when it was determined that it was safe for patients.
Until discharge from the hospital, a re-evaluation of neuromuscular and respiratory function was performed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
functional outcome of activity of daily living
Time Frame: up to three weeks
|
Bartel index (BI)
|
up to three weeks
|
|
functional outcome of cardiovascular and respiratory system
Time Frame: up to three weeks
|
six minute walk test (6MWT)
|
up to three weeks
|
|
functional outcome for assesing dyspnea
Time Frame: up to three weeks
|
Borg scale for dyspnea,
|
up to three weeks
|
|
functional outcome of mobility
Time Frame: up to three weeks
|
"Time Up and Go" test (TUG)
|
up to three weeks
|
|
functional outcome of lower limbs strength
Time Frame: up to three weeks
|
"Sit To Stand" test (STS)
|
up to three weeks
|
|
functional outcome of static balance
Time Frame: up to three weeks
|
"One Leg Stance Test" (OLST)
|
up to three weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2021
Primary Completion (Anticipated)
December 1, 2022
Study Completion (Anticipated)
January 1, 2023
Study Registration Dates
First Submitted
November 14, 2022
First Submitted That Met QC Criteria
November 15, 2022
First Posted (Actual)
November 17, 2022
Study Record Updates
Last Update Posted (Actual)
November 17, 2022
Last Update Submitted That Met QC Criteria
November 15, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 02/269-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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
-
PfizerActive, not recruitingCOVID-19 | Coronavirus Disease 2019 (COVID-19) | COVID-19 Infection | COVID-19 Vaccines | SARS-CoV-2 Infection, COVID19 | COVID-19 Vaccination | SARS-CoV-2 Infection, COVID-19 | COVID-19 (Coronavirus Disease 2019) | COVID-19 SARS-CoV-2 InfectionUnited States
-
Shanghai Public Health Clinical CenterNot yet recruiting
-
Duke UniversityNational Institute on Minority Health and Health Disparities (NIMHD)Completed
-
Eggensberger OHGBavarian Health and Food Safety Authority (LGL)RecruitingPost COVID-19 Condition | Post COVID-19 | Post COVID-19 Syndrome | Long COVID-19 Syndrome | Post COVID-19 Condition (PCC)Germany
-
PfizerRecruitingRespiratory Tract Diseases | COVID-19 | Pneumonia | Lung Diseases | Coronavirus Disease 2019 | Coronavirus Disease 2019 (COVID-19) | COVID-19 Infection | Upper Respiratory Tract Infections | Respiratory Tract Infection | COVID-19 (Coronavirus Disease 2019) | COVID-19 SARS-CoV-2 InfectionBelgium
-
ModeX Therapeutics, An OPKO Health CompanyRecruitingCOVID -19 | COVID-19 (Prevention)United States
-
Lawson Research Institute of St. Joseph'sCanadian Institutes of Health Research (CIHR); Western University, CanadaRecruitingFatigue | Post-COVID-19 Syndrome | Post COVID-19 Condition | Post-COVID Syndrome | Long COVID-19 | Long-COVID | Post-COVID ConditionCanada
-
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
-
Indonesia UniversityRecruitingPost-COVID-19 Syndrome | Long COVID | Post COVID-19 Condition | Post-COVID Syndrome | Long COVID-19Indonesia
Clinical Trials on Acute rehabilitation program
-
Muhammed Onur HanedanCompletedCardiac Rehabilitation | Coronary Artery Bypass SurgeryTurkey
-
University of ZurichNational Center of Cardiology and Internal Medicine named after academician...Completed
-
Bispebjerg HospitalUniversity of CopenhagenCompleted
-
Borja Alcobía-Díaz MD, PhDNot yet recruiting
-
University Hospital, LimogesRecruiting
-
Assistance Publique - Hôpitaux de ParisRecruitingQuality of Life | Facial Palsy | Motor Recovery | Self-rehabilitationFrance
-
University Hospital, GrenobleCompletedPeripheral Arterial Disease | ClaudicationFrance
-
Samsung Medical CenterJohns Hopkins UniversityNot yet recruitingPediatric Intensive Care UnitsSouth Korea
-
Fundación Pública Andaluza para la gestión de la...Unknown
-
Assistance Publique - Hôpitaux de ParisNot yet recruiting