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Acute Rehabilitation in Patients With COVID-19 Pneumonia

Primary Purpose

COVID-19, Rehabilitation, Physical Medicine

Status
Recruiting
Phase
Not Applicable
Locations
Serbia
Study Type
Interventional
Intervention
Acute rehabilitation program
Sponsored by
Institut za Rehabilitaciju Sokobanjska Beograd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring Acute rehabilitation, COVID-19 pneumonia

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tamara FilipovicRecruiting
  • Institute for RehabilitationRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Severity of COVID-19 infection

Arm Description

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.

Outcomes

Primary Outcome Measures

functional outcome of activity of daily living
Bartel index (BI)
functional outcome of cardiovascular and respiratory system
six minute walk test (6MWT)
functional outcome for assesing dyspnea
Borg scale for dyspnea,
functional outcome of mobility
"Time Up and Go" test (TUG)
functional outcome of lower limbs strength
"Sit To Stand" test (STS)
functional outcome of static balance
"One Leg Stance Test" (OLST)

Secondary Outcome Measures

Full Information

First Posted
November 14, 2022
Last Updated
November 15, 2022
Sponsor
Institut za Rehabilitaciju Sokobanjska Beograd
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1. Study Identification

Unique Protocol Identification Number
NCT05619666
Brief Title
Acute Rehabilitation in Patients With COVID-19 Pneumonia
Official Title
Acute Rehabilitation in Patients With COVID-19 Pneumonia a Single Center Experience From a Developing Country
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
January 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut za Rehabilitaciju Sokobanjska Beograd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Rehabilitation, Physical Medicine
Keywords
Acute rehabilitation, COVID-19 pneumonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Severity of COVID-19 infection
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Acute rehabilitation program
Intervention Description
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.
Primary Outcome Measure Information:
Title
functional outcome of activity of daily living
Description
Bartel index (BI)
Time Frame
up to three weeks
Title
functional outcome of cardiovascular and respiratory system
Description
six minute walk test (6MWT)
Time Frame
up to three weeks
Title
functional outcome for assesing dyspnea
Description
Borg scale for dyspnea,
Time Frame
up to three weeks
Title
functional outcome of mobility
Description
"Time Up and Go" test (TUG)
Time Frame
up to three weeks
Title
functional outcome of lower limbs strength
Description
"Sit To Stand" test (STS)
Time Frame
up to three weeks
Title
functional outcome of static balance
Description
"One Leg Stance Test" (OLST)
Time Frame
up to three weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Tamara Filipovic
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamara Filipovic
Phone
+381652832505
Email
tamarabackovic@gmail.com
First Name & Middle Initial & Last Name & Degree
Milica Lazovic
Phone
+38163410058
Email
MilicaLazovic15@gmail.com
Facility Name
Institute for Rehabilitation
City
Belgrade
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamara Filipovic, Phd
Phone
381652832505
Email
tamarabackovic@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Acute Rehabilitation in Patients With COVID-19 Pneumonia

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