Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-25 @ 8:12 PM
Study NCT ID:
NCT01777035
Status:
COMPLETED
Last Update Posted:
2022-02-21
First Post:
2013-01-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Early Mobilization in the ICU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-17', 'studyFirstSubmitDate': '2013-01-16', 'studyFirstSubmitQcDate': '2013-01-23', 'lastUpdatePostDateStruct': {'date': '2022-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'presence of cognitive impairment', 'timeFrame': 'within the first 30 days after ICU admission'}, {'measure': 'presence of cognitive impairment', 'timeFrame': 'up to 1 year post discharge'}], 'secondaryOutcomes': [{'measure': 'cognitive test score', 'timeFrame': 'up to 1 year post discharge', 'description': 'includes variables\n\n1. orientation\n2. attention\n3. memory\n4. reasoning\n5. executive function'}, {'measure': 'institution free days', 'timeFrame': 'up to 1 yr post discharge', 'description': 'number of days not requiring inpatient admission'}, {'measure': 'Insulin Resistance', 'timeFrame': 'day 3 of mechanical ventilation', 'description': 'Measuring insulin resistance and glycemic control in patients who are still mechanically ventilated on third day of enrollment in the study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['mechanical ventilation', 'physical therapy', 'occupational therapy', 'ICU acquired weakness', 'critical illness myopathy'], 'conditions': ['Respiratory Failure']}, 'referencesModule': {'references': [{'pmid': '36693400', 'type': 'DERIVED', 'citation': 'Patel BK, Wolfe KS, Patel SB, Dugan KC, Esbrook CL, Pawlik AJ, Stulberg M, Kemple C, Teele M, Zeleny E, Hedeker D, Pohlman AS, Arora VM, Hall JB, Kress JP. Effect of early mobilisation on long-term cognitive impairment in critical illness in the USA: a randomised controlled trial. Lancet Respir Med. 2023 Jun;11(6):563-572. doi: 10.1016/S2213-2600(22)00489-1. Epub 2023 Jan 21.'}, {'pmid': '30217640', 'type': 'DERIVED', 'citation': 'Wolfe KS, Patel BK, MacKenzie EL, Giovanni SP, Pohlman AS, Churpek MM, Hall JB, Kress JP. Impact of Vasoactive Medications on ICU-Acquired Weakness in Mechanically Ventilated Patients. Chest. 2018 Oct;154(4):781-787. doi: 10.1016/j.chest.2018.07.016. Epub 2018 Sep 11.'}]}, 'descriptionModule': {'briefSummary': 'To study all ICU patients with an independent baseline functional status , who experience a critical illness requiring intubation and mechanical ventilation evaluating long-term cognitive and executive function and long term cost effectiveness in survivors who required mechanical ventilation.', 'detailedDescription': 'Immediate mobilization of mechanically ventilated (MV) ICU patients is not part of usual care in the U.S. or internationally. Our previous work supports that early mobilization through physical and occupational therapy for ICU patients on the ventilator can help them experience less delirium, spend less time in the ICU and hospital, and become more independent when they leave. To advance our knowledge in this area, large longitudinal studies are needed to understand the long-term physical, cognitive and mental health status of survivors and to test how specific ICU therapies may affect these outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Intubated and MV \\> 24, \\< 96 hours\n* Baseline Barthel Index Functional Score \\> 70, functional at home\n\nExclusion Criteria:\n\n* Rapidly changing neurological conditions (e.g. stroke)\n* Cardiac arrest as cause for respiratory failure\n* Elevated intracranial pressure\n* Pregnancy (due to inability to provide continuous fetal monitoring)\n* Terminal condition (life expectancy \\< 6 months)\n* Traumatic brain injury, multiple limb fractures, pelvic fractures,\n* Severe chronic pain syndrome on admission'}, 'identificationModule': {'nctId': 'NCT01777035', 'briefTitle': 'Early Mobilization in the ICU', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'Early Mobilization in the ICU', 'orgStudyIdInfo': {'id': '11-0218'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early physical therapy(PT) occupational therapy (OT)', 'description': 'Early PT OT assessments begin on first day of study. Therapy delivered by a team consisting of physical and occupational therapists and coordinated with daily sedative interruption', 'interventionNames': ['Other: early PT OT']}, {'type': 'NO_INTERVENTION', 'label': 'standard care', 'description': 'PT OT delivered as ordered by the primary ICU team'}], 'interventions': [{'name': 'early PT OT', 'type': 'OTHER', 'description': '1. Passive range of motion (ROM) in pts who remain unresponsive despite sedative interruption.\n2. active assisted ROM in supine position.\n3. treatment is advanced to bed mobility activities\n4. sitting balance activities followed by participation in activities of daily living (ADLs) and exercises that encourage increased independence with functional tasks.\n5. progression to transfer training, and finally pre-gait training and ambulation.\n6. progression of activities dependent on patient tolerance and stability\n7. therapy sessions continue on a daily basis throughout hospital stay until return to prior level of function or is discharged.', 'armGroupLabels': ['Early physical therapy(PT) occupational therapy (OT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'John P Kress, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}