COVID-19NCT05619666
Acute Rehabilitation in Patients With COVID-19 Pneumonia
A study testing Acute rehabilitation program in people with COVID-19 and Rehabilitation, run by Institut za Rehabilitaciju Sokobanjska Beograd at 2 sites in Serbia.
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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- COVID-19, Rehabilitation, Physical Medicine
- What is being tested?
- Acute rehabilitation program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesSerbia
- Study dates
- 1 Sep 2021to Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%;
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Serbia2 sites, 2 recruiting
- Recruiting
Tamara Filipovic
Belgrade, 11000
Tamara Filipovic, +381652832505, tamarabackovic@gmail.com
Milica Lazovic, +38163410058, MilicaLazovic15@gmail.com
- Recruiting
Institute for Rehabilitation
Belgrade
Tamara Filipovic, Phd, 381652832505, tamarabackovic@gmail.com
About this study
Official title: 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.
- Conditions
- COVID-19, Rehabilitation, Physical Medicine
- Being tested
- Acute rehabilitation program
- Keywords
- Acute rehabilitation, COVID-19 pneumonia
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute rehabilitation programProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Acute rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional outcome of activity of daily living
Bartel index (BI)
Measured: up to three weeks
functional outcome of cardiovascular and respiratory system
six minute walk test (6MWT)
Measured: up to three weeks
functional outcome for assesing dyspnea
Borg scale for dyspnea,
Measured: up to three weeks
functional outcome of mobility
"Time Up and Go" test (TUG)
Measured: up to three weeks
functional outcome of lower limbs strength
"Sit To Stand" test (STS)
Measured: up to three weeks
functional outcome of static balance
"One Leg Stance Test" (OLST)
Measured: up to three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start1 Sep 2021
- Primary completionDec 2022 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut za Rehabilitaciju Sokobanjska Beograd
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamara Filipovic, Institut za Rehabilitaciju Sokobanjska Beograd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05619666
- Sponsor's protocol ID
- 02/269-1
- Status last verified
- Nov 2022
- First submitted
- 14 Nov 2022
- Last updated
- 17 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Rehabilitation in Patients With COVID-19 Pneumonia a Single Center Experience From a Developing Country
- ClinicalTrials.gov ID
- NCT05619666
- Acronym / sponsor ID
- 02/269-1
- Conditions
- COVID-19, Rehabilitation, Physical Medicine
- Keywords
- Acute rehabilitation, COVID-19 pneumonia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Institut za Rehabilitaciju Sokobanjska BeogradUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 17 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severity of COVID-19 infection | Other | Procedure: Acute rehabilitation programBased 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. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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%;
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acute rehabilitation programPatients 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. | Procedure or surgery | Severity of COVID-19 infection |
Primary outcome
functional outcome of activity of daily living
Time frame: up to three weeks
Bartel index (BI)
functional outcome of cardiovascular and respiratory system
Time frame: up to three weeks
six minute walk test (6MWT)
functional outcome for assesing dyspnea
Time frame: up to three weeks
Borg scale for dyspnea,
functional outcome of mobility
Time frame: up to three weeks
"Time Up and Go" test (TUG)
functional outcome of lower limbs strength
Time frame: up to three weeks
"Sit To Stand" test (STS)
functional outcome of static balance
Time frame: up to three weeks
"One Leg Stance Test" (OLST)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute rehabilitation program in people with COVID-19 and Rehabilitation, run by Institut za Rehabilitaciju Sokobanjska Beograd at 2 sites in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional outcome of activity of daily living (time frame: up to three weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2022.