NCT05619666

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.

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
200

participants targeted

Target at P50-P75 for not_applicable covid19

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable covid19

Geographic Reach
1 country

2 active sites

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

September 1, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 17, 2022

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

November 17, 2022

Status Verified

November 1, 2022

Enrollment Period

1.2 years

First QC Date

November 14, 2022

Last Update Submit

November 15, 2022

Conditions

Keywords

Acute rehabilitationCOVID-19 pneumonia

Outcome Measures

Primary Outcomes (6)

  • functional outcome of activity of daily living

    Bartel index (BI)

    up to three weeks

  • functional outcome of cardiovascular and respiratory system

    six minute walk test (6MWT)

    up to three weeks

  • functional outcome for assesing dyspnea

    Borg scale for dyspnea,

    up to three weeks

  • functional outcome of mobility

    "Time Up and Go" test (TUG)

    up to three weeks

  • functional outcome of lower limbs strength

    "Sit To Stand" test (STS)

    up to three weeks

  • functional outcome of static balance

    "One Leg Stance Test" (OLST)

    up to three weeks

Study Arms (1)

Severity of COVID-19 infection

OTHER

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

Interventions

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.

Severity of COVID-19 infection

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%;

You may not qualify if:

  • \) 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tamara Filipovic

Belgrade, 11000, Serbia

RECRUITING

Institute for Rehabilitation

Belgrade, Serbia

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching assistant

Study Record Dates

First Submitted

November 14, 2022

First Posted

November 17, 2022

Study Start

September 1, 2021

Primary Completion

December 1, 2022

Study Completion

January 1, 2023

Last Updated

November 17, 2022

Record last verified: 2022-11

Locations