Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2026-04-06 @ 3:08 PM
Study NCT ID:
NCT00976833
Status:
COMPLETED
Last Update Posted:
2018-08-10
First Post:
2009-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Standardized Rehabilitation for Intensive Care Unit (ICU) Patients With Acute Respiratory Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-08', 'studyFirstSubmitDate': '2009-09-11', 'studyFirstSubmitQcDate': '2009-09-11', 'lastUpdatePostDateStruct': {'date': '2018-08-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine whether standardized rehabilitation therapy will decrease hospital length of stay.', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute Respiratory Failure', 'Early ICU Mobility', 'Early Physical Therapy', 'Critical Care', 'Intensive Care', 'ICU'], 'conditions': ['Acute Respiratory Failure']}, 'referencesModule': {'references': [{'pmid': '30571923', 'type': 'DERIVED', 'citation': 'Gandotra S, Lovato J, Case D, Bakhru RN, Gibbs K, Berry M, Files DC, Morris PE. Physical Function Trajectories in Survivors of Acute Respiratory Failure. Ann Am Thorac Soc. 2019 Apr;16(4):471-477. doi: 10.1513/AnnalsATS.201806-375OC.'}, {'pmid': '27367766', 'type': 'DERIVED', 'citation': 'Morris PE, Berry MJ, Files DC, Thompson JC, Hauser J, Flores L, Dhar S, Chmelo E, Lovato J, Case LD, Bakhru RN, Sarwal A, Parry SM, Campbell P, Mote A, Winkelman C, Hite RD, Nicklas B, Chatterjee A, Young MP. Standardized Rehabilitation and Hospital Length of Stay Among Patients With Acute Respiratory Failure: A Randomized Clinical Trial. JAMA. 2016 Jun 28;315(24):2694-702. doi: 10.1001/jama.2016.7201.'}]}, 'descriptionModule': {'briefSummary': "Acute Respiratory Failure (ARF) requiring mechanical ventilation affects 1.1 million of the 4.4 million people admitted to United States Intensive Care Units (ICU) every year. Patients with ARF have an average ICU and hospital length of stay (LOS) of 8 and 15 days, respectively, with median hospital costs greater than $30,000 United States. Patients with ARF experience deconditioning, muscle weakness, joint contractures, dyspnea, depression, and reduced health-related quality of life, all of which may contribute to prolonged hospitalization and increased costs. Mechanistically, it is understood that patients with ARF demonstrate acute inflammation which may contribute to the above cited problems. While the investigators' research and that of others has shown that rehabilitation therapy can increase functional outcomes while lowering biomarkers of inflammation in the frail aged and other clinical populations, it is not known whether such rehabilitation therapy can result in improved functional capacity and functional performance and reduce inflammation in ARF patients. There is previous evidence for the feasibility and safety of rehabilitation therapy in ARF patients. Therefore, the investigators propose a two-arm, randomized trial in 326 patients with ARF to compare Standardized Rehabilitation Therapy initiated in the ICU and administered throughout the hospitalization versus usual care (control). Standardized Rehabilitation Therapy will consist of: passive range of motion, physical therapy and progressive resistance exercise (strength training). The regimen will be administered 7 days/week by a Mobility Team consisting of a critical care nurse, physical therapist and nursing assistant.\n\nThe investigators will determine whether standardized rehabilitation therapy will reduce hospital LOS, improve functional capacity and performance, improve quality of life, reduce inflammation and reduce hospital costs as compared to usual care.\n\nThis study's primary objective is to determine whether standardized rehabilitation therapy will decrease hospital length of stay.\n\nHypothesis: Compared to usual care, standardized rehabilitation therapy will reduce hospital length of stay for patients with Acute Respiratory Failure."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Mechanically ventilated via an Endotracheal tube or Bipap\n* Lung Injury\n\nExclusion Criteria:\n\n* Previously enrolled in TARGET STUDY\n* Inability to walk without assistance prior to acute ICU illness (use of a cane or walker not exclusion)\n* Cognitive impairment prior to acute ICU illness (non-verbal)\n* Acute stroke\n* Body mass index (BMI) \\> 50\n* Neuromuscular disease that could impair weaning\n* Hip fracture, unstable cervical spine or pathological fracture\n* Mechanically ventilated \\> 80 hours\n* Current hospitalization or transferring hospital stay \\> 7 days\n* Ineligible cancer treatment within the last 6 month\n* Moribund\n* Do Not Resuscitate(DNR)/Do Not Intubate(DNI) on admission\n* Other Research Study'}, 'identificationModule': {'nctId': 'NCT00976833', 'briefTitle': 'Standardized Rehabilitation for Intensive Care Unit (ICU) Patients With Acute Respiratory Failure', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Standardized Rehabilitation for ICU Patients With Acute Respiratory Failure', 'orgStudyIdInfo': {'id': 'IRB00007879'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care', 'description': 'Usual Care', 'interventionNames': ['Other: Usual Care']}, {'type': 'OTHER', 'label': 'Standardized Rehabilitation', 'description': 'Intervention arm to receive Standardized Rehabilitation Therapy', 'interventionNames': ['Other: Standardized Rehabilitation']}], 'interventions': [{'name': 'Standardized Rehabilitation', 'type': 'OTHER', 'description': '3 component Rehabilitation approach, Passive Range of Motion, Physical Therapy and Progressive Resistance Training', 'armGroupLabels': ['Standardized Rehabilitation']}, {'name': 'Usual Care', 'type': 'OTHER', 'description': 'Usual Physical Therapy care', 'armGroupLabels': ['Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Health Sciences', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Peter E. Morris, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}