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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05619666
Other study ID # 02/269-1
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2021
Est. completion date January 2023

Study information

Verified date November 2022
Source Institut za Rehabilitaciju Sokobanjska Beograd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date January 2023
Est. primary completion date December 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 95 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Serbia Institute for Rehabilitation Belgrade
Serbia Tamara Filipovic Belgrade

Sponsors (1)

Lead Sponsor Collaborator
Institut za Rehabilitaciju Sokobanjska Beograd

Country where clinical trial is conducted

Serbia, 

Outcome

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