Acute Rehabilitation in Patients With COVID-19 Pneumonia

Sponsor

Institut za Rehabilitaciju Sokobanjska Beograd (Other)

Overall Status

Recruiting

CT.gov ID

NCT05619666

Collaborator

(none)

200

Enrollment

Locations

Arm

Anticipated Duration (Months)

100

Patients Per Site

6.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Rehabilitation Physical Medicine	Procedure: Acute rehabilitation program	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Acute Rehabilitation in Patients With COVID-19 Pneumonia a Single Center Experience From a Developing Country

Actual Study Start Date :

Sep 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

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.	Procedure: Acute rehabilitation program 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.

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.

Procedure: Acute rehabilitation program

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 95 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tamara Filipovic	Belgrade		Serbia	11000
2	Institute for Rehabilitation	Belgrade		Serbia

Sponsors and Collaborators

Institut za Rehabilitaciju Sokobanjska Beograd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tamara Filipovic, Teaching assistant, Institut za Rehabilitaciju Sokobanjska Beograd

ClinicalTrials.gov Identifier:

NCT05619666

Other Study ID Numbers:

02/269-1

First Posted:

Nov 17, 2022

Last Update Posted:

Nov 17, 2022

Last Verified:

Nov 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Tamara Filipovic, Teaching assistant, Institut za Rehabilitaciju Sokobanjska Beograd

Acute rehabilitation

COVID-19 pneumonia

Additional relevant MeSH terms:

COVID-19

Pneumonia

Study Results

No Results Posted as of Nov 17, 2022