Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-26 @ 1:20 PM
Study NCT ID:
NCT01637467
Status:
COMPLETED
Last Update Posted:
2016-02-09
First Post:
2012-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Electrical Muscle Stimulation in Critically Ill Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D009135', 'term': 'Muscular Diseases'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-05', 'studyFirstSubmitDate': '2012-07-06', 'studyFirstSubmitQcDate': '2012-07-10', 'lastUpdatePostDateStruct': {'date': '2016-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'feasibility of EMS treatment', 'timeFrame': '4 weeks', 'description': 'the number of EMS treatments that are successfully applied will be expressed as a frequency of the total number of treatments attempted'}], 'secondaryOutcomes': [{'measure': 'muscle strength', 'timeFrame': 'baseline, 2 weeks and 4 weeks', 'description': 'muscle strength using manual muscle testing'}, {'measure': 'muscle thickness', 'timeFrame': 'baseline, 2 weeks, 4 weeks', 'description': 'thickness of the quadriceps muscle will be assessed using muscle ultrasound'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['critical illness', 'myopathy', 'electrical muscle stimulation'], 'conditions': ['Critical Illness']}, 'descriptionModule': {'briefSummary': 'Electrical muscle stimulation (EMS) is the therapy used to passively activate muscles using electrodes on the surface of the skin. EMS may be helpful in preserving muscle function in people who are on bedrest due to critical illness in the intensive care unit. The purpose of this study is to determine the safety and feasibility of implementing EMS in critically ill patients who are on mechanical ventilation for greater than 7 days, and examine the effects of 4 weeks of EMS on leg muscle size, muscle strength and functional outcomes in these patients. The investigators hypothesize that EMS will be safe and feasible and that critically ill patients receiving EMS will show a smaller loss of muscle size and strength than those in the control group, who do not receive EMS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* admitted to the medical-surgical ICU or cardiovascular ICU\n* walking independently prior to admission\n* mechanically ventilated for more than 7 days (i.e. prolonged ventilation)\n* receiving enteral or parenteral nutrition.\n\nExclusion Criteria:\n\n* history of neurological or psychiatric disease\n* primary muscle disease (e.g. muscular dystrophy, polymyositis)\n* catastrophic neurological event\n* receiving palliative care\n* contraindications to EMS (e.g. cardiac pacemaker/defibrillator, pregnancy, infected or cancerous lesions in proximity of electrode sites)\n* inadequate access to electrode sites due to medical devices\n* lower extremity edema affecting the thighs or buttocks\n* BMI \\> 35 kg/m2\n* allergies to adhesives or latex'}, 'identificationModule': {'nctId': 'NCT01637467', 'briefTitle': 'Effect of Electrical Muscle Stimulation in Critically Ill Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'The Effects of Electrical Muscle Stimulation (EMS) on Muscle Atrophy and Functional Outcomes in Critically Ill Patients; a Pilot Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '11-0639A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EMS intervention', 'description': 'The experimental group will received EMS at a therapeutic level.', 'interventionNames': ['Other: Electrical muscle stimulation (EMS)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham', 'description': 'The sham group will receive EMS at a sub-therapeutic level.', 'interventionNames': ['Other: Sham EMS']}], 'interventions': [{'name': 'Electrical muscle stimulation (EMS)', 'type': 'OTHER', 'description': 'EMS delivered to the quadriceps and gluteal muscles, twice daily, 30 minutes per session for up to 4 weeks.', 'armGroupLabels': ['EMS intervention']}, {'name': 'Sham EMS', 'type': 'OTHER', 'description': 'Sham EMS delivered to the quadriceps and gluteal muscles, twice daily, 30 minutes per session for up to 4 weeks.', 'armGroupLabels': ['Sham']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 2C4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto General Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Vincent Lo, BSc(PT)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Health Network, Toronto'}, {'name': 'Sunita Mathur, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Toronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Lung Association', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sunita Mathur', 'investigatorAffiliation': 'University Health Network, Toronto'}}}}