Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2026-02-26 @ 10:53 AM
Study NCT ID:
NCT05619666
Status:
UNKNOWN
Last Update Posted:
2022-11-17
First Post:
2022-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Rehabilitation in Patients With COVID-19 Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-15', 'studyFirstSubmitDate': '2022-11-14', 'studyFirstSubmitQcDate': '2022-11-15', 'lastUpdatePostDateStruct': {'date': '2022-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'functional outcome of activity of daily living', 'timeFrame': 'up to three weeks', 'description': 'Bartel index (BI)'}, {'measure': 'functional outcome of cardiovascular and respiratory system', 'timeFrame': 'up to three weeks', 'description': 'six minute walk test (6MWT)'}, {'measure': 'functional outcome for assesing dyspnea', 'timeFrame': 'up to three weeks', 'description': 'Borg scale for dyspnea,'}, {'measure': 'functional outcome of mobility', 'timeFrame': 'up to three weeks', 'description': '"Time Up and Go" test (TUG)'}, {'measure': 'functional outcome of lower limbs strength', 'timeFrame': 'up to three weeks', 'description': '"Sit To Stand" test (STS)'}, {'measure': 'functional outcome of static balance', 'timeFrame': 'up to three weeks', 'description': '"One Leg Stance Test" (OLST)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute rehabilitation', 'COVID-19 pneumonia'], 'conditions': ['COVID-19', 'Rehabilitation', 'Physical Medicine']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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%;\n\nExclusion Criteria:\n\n* 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.'}, 'identificationModule': {'nctId': 'NCT05619666', 'briefTitle': 'Acute Rehabilitation in Patients With COVID-19 Pneumonia', 'organization': {'class': 'OTHER', 'fullName': 'Institut za Rehabilitaciju Sokobanjska Beograd'}, 'officialTitle': 'Acute Rehabilitation in Patients With COVID-19 Pneumonia a Single Center Experience From a Developing Country', 'orgStudyIdInfo': {'id': '02/269-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Severity of COVID-19 infection', '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.', 'interventionNames': ['Procedure: Acute rehabilitation program']}], 'interventions': [{'name': 'Acute rehabilitation program', 'type': 'PROCEDURE', '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.', 'armGroupLabels': ['Severity of COVID-19 infection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11000', 'city': 'Belgrade', 'status': 'RECRUITING', 'country': 'Serbia', 'contacts': [{'name': 'Tamara Filipovic', 'role': 'CONTACT', 'email': 'tamarabackovic@gmail.com', 'phone': '+381652832505'}, {'name': 'Milica Lazovic', 'role': 'CONTACT', 'email': 'MilicaLazovic15@gmail.com', 'phone': '+38163410058'}], 'facility': 'Tamara Filipovic', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'city': 'Belgrade', 'status': 'RECRUITING', 'country': 'Serbia', 'contacts': [{'name': 'Tamara Filipovic, Phd', 'role': 'CONTACT', 'email': 'tamarabackovic@gmail.com', 'phone': '381652832505'}], 'facility': 'Institute for Rehabilitation', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut za Rehabilitaciju Sokobanjska Beograd', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Teaching assistant', 'investigatorFullName': 'Tamara Filipovic', 'investigatorAffiliation': 'Institut za Rehabilitaciju Sokobanjska Beograd'}}}}