Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2026-02-22 @ 10:51 AM
Study NCT ID:
NCT01717833
Status:
UNKNOWN
Last Update Posted:
2015-06-18
First Post:
2012-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of NEMS for Post ICU Rehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C005703', 'term': 'salicylhydroxamic acid'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-06-17', 'studyFirstSubmitDate': '2012-10-21', 'studyFirstSubmitQcDate': '2012-10-28', 'lastUpdatePostDateStruct': {'date': '2015-06-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Muscle strength in patients with ICU acquired weakness (ICUAW) at ICU discharge', 'timeFrame': 'up to 2.5 years', 'description': 'In the subgroup of patients diagnosed with ICUAW improvement in muscle strength will be assessed in patients of the NEMS group as compared to the sham-NEMS group'}], 'primaryOutcomes': [{'measure': 'Muscle strength', 'timeFrame': 'up to 2.5 years'}], 'secondaryOutcomes': [{'measure': 'Duration of hospital stay', 'timeFrame': 'up to 2.5 years'}, {'measure': 'Functional ability', 'timeFrame': 'up to 2.5 years', 'description': 'Functional ability will be assessed with the FIM score'}, {'measure': 'Quality of life', 'timeFrame': 'up to 2.5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ICU acquired weakness', 'Critical illness polyneuromyopathy', 'post ICU rehabilitation', 'neuromuscular electrical rehabilitation', 'handgrip'], 'conditions': ['Critical Illness']}, 'referencesModule': {'references': [{'pmid': '28364678', 'type': 'DERIVED', 'citation': 'Patsaki I, Gerovasili V, Sidiras G, Karatzanos E, Mitsiou G, Papadopoulos E, Christakou A, Routsi C, Kotanidou A, Nanas S. Effect of neuromuscular stimulation and individualized rehabilitation on muscle strength in Intensive Care Unit survivors: A randomized trial. J Crit Care. 2017 Aug;40:76-82. doi: 10.1016/j.jcrc.2017.03.014. Epub 2017 Mar 22.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the role of NEMS as a rehabilitation tool for muscle weakness following critical illness. The investigators hypothesized that NEMS combined with exercise rehabilitation will have a beneficial role in restoration of muscle strength', 'detailedDescription': 'Survivors of critical illness are presented with significant physical impairment that is associated with reduced functional ability and health -related quality of life both in the short and long-term.\n\nNeuromuscular electrical stimulation (NEMS) has been proposed as an alternative exercise modality in patients with severe chronic obstructive pulmonary disease and chronic heart failure, who cannot perform active exercise. NEMS has also been used as a preventive tool for intensive care unit (ICU) acquired weakness (ICUAW). Its role as a tool for post ICU rehabilitation has not been evaluated so far.\n\nA randomized intervention study was designed to assess the efficacy of NEMS, as a rehabilitative tool for critical illness survivors. The first day that patients are discharged from the ICU after stratified randomization are assigned to the NEMS group or to the control group. In the NEMS group, NEMS will be applied to both lower extremities of the NEMS -group simultaneously (quadriceps femoris muscle and peroneus longus) on a daily basis, along with a personalized exercise program. NEMS sessions will continue until patient discharge from hospital. In the control group, sham NEMS will be applied along with standard care when it comes to physiotherapy. At hospital discharge patients of both groups of will receive a rehabilitation booklet. Patients on the NEMS group that have significant muscle weakness will have NEMS sessions at home for a period of 2 months. Patients are evaluated at 3 and 6 months after hospital discharge'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients under mechanical ventilation for\\> 72hours during ICU stay\n* Patients able to perform simple commands (able to be evaluated by MRC scale)\n\nExclusion Criteria:\n\n* age \\< 18 \\> 85 years\n* pregnancy\n* pre-existing neuromuscular disease (e.g. Gravis)\n* fractures or skin lesions that do not allow the implementation of NEMS\n* presence of pacemaker or defibrillator\n* fractures of spine that so not allow mobilization\n* BMI \\> 35 kg/m2\n* terminal disease'}, 'identificationModule': {'nctId': 'NCT01717833', 'briefTitle': 'The Role of NEMS for Post ICU Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'University of Athens'}, 'officialTitle': 'The Role of Neuromuscular Electrical Stimulation as a Tool for Post ICU Rehabilitation', 'orgStudyIdInfo': {'id': 'SN01032010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NEMS group', 'interventionNames': ['Procedure: NEMS']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham group', 'interventionNames': ['Procedure: Sham']}], 'interventions': [{'name': 'NEMS', 'type': 'PROCEDURE', 'otherNames': ['Neuromuscular Electrical stimulation'], 'description': 'NEMS sessions on both lower extremities (quadriceps and peroneus longus) simultaneously', 'armGroupLabels': ['NEMS group']}, {'name': 'Sham', 'type': 'PROCEDURE', 'otherNames': ['Sham neuromuscular electrical stimulation'], 'description': 'Sham sessions of neuromuscular electrical stimulation', 'armGroupLabels': ['Sham group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Athens', 'country': 'Greece', 'facility': 'First Critical Care Unit, Evaggelismos Hospital, School of Medicine', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'overallOfficials': [{'name': 'Serafim Nanas, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Athens'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Athens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Serafim Nanas', 'investigatorAffiliation': 'University of Athens'}}}}