Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2026-01-29 @ 6:02 PM
Study NCT ID:
NCT07179718
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-18
First Post:
2025-09-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intensive Care Unit Rehabilitation Protocols
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-11', 'studyFirstSubmitDate': '2025-09-11', 'studyFirstSubmitQcDate': '2025-09-11', 'lastUpdatePostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Perme Intensive Care Unit Mobility Score over 5 days', 'timeFrame': '1st and 5th day of 5-day physiotherapy and rehabilitation after the patient is clinically stable', 'description': 'The total score ranges from 0 to 32 points, with higher scores indicating better mobility and greater independence.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Critical Illness', 'ICU Patients']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to investigate the effects of NMES combination applied in addition to bicycle ergometry on mobility, functional status, muscle strength and hemodynamic responses in ICU patients.\n\nParticipants will:\n\n* Exercise training will be performed using the bicycle ergometer method, under the supervision of a physiotherapist, for 30 minutes a day for 5 consecutive days, at the earliest stage when the patient is clinically stable.\n* The other group will perform a 30-minute quadriceps muscle NMES session applied with a 4-channel electrical stimulator for 5 consecutive days in addition to the bicycle ergometer.\n* Evaluations for both groups will be made on the first day of the study (before starting the exercise training) and at the end of the fifth day (after the exercise training).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Admitted to medical intensive care unit\n* Expected intensive care unit stay \\> 48 hours\n* Hemodynamically stable\n\nExclusion Criteria:\n\n* Severe neurological injury (e.g., acute stroke, spinal cord injury)\n* Terminal illness with palliative care decision\n* Severe orthopedic limitations preventing mobilization\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT07179718', 'acronym': 'ICU-Rehab', 'briefTitle': 'Intensive Care Unit Rehabilitation Protocols', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Effects of Two Different Rehabilitation Protocols on Mobility, Functional Status, Muscle Parameters, and Hemodynamic Responses in Intensive Care Patients', 'orgStudyIdInfo': {'id': 'KA-22100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'bicycle ergometer group', 'description': 'Exercise training will be performed using the bicycle ergometer method, under the supervision of a physiotherapist, for 30 minutes a day for 5 consecutive days, at the earliest stage when the patient is clinically stable.', 'interventionNames': ['Device: bicycle ergometer']}, {'type': 'EXPERIMENTAL', 'label': 'bicycle ergometer + neuromuscular electrical stimulation group', 'description': 'Group will perform a 30-minute quadriceps muscle NMES session applied with a 4-channel electrical stimulator for 5 consecutive days in addition to the bicycle ergometer.', 'interventionNames': ['Device: neuromuscular electrical stimulation', 'Device: bicycle ergometer']}], 'interventions': [{'name': 'neuromuscular electrical stimulation', 'type': 'DEVICE', 'description': 'Neuromuscular electrical stimulation (NMES) is a treatment method in which electrical conduction via surface electrodes is used to stimulate muscle contraction.', 'armGroupLabels': ['bicycle ergometer + neuromuscular electrical stimulation group']}, {'name': 'bicycle ergometer', 'type': 'DEVICE', 'description': 'Exercise training will be performed using the bicycle ergometer method, under the supervision of a physiotherapist, for 30 minutes a day for 5 consecutive days, at the earliest stage when the patient is clinically stable.', 'armGroupLabels': ['bicycle ergometer + neuromuscular electrical stimulation group', 'bicycle ergometer group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06230', 'city': 'Ankara', 'state': 'ALTINDAG', 'country': 'Turkey (Türkiye)', 'facility': 'Hacettepe University Medical Intensive Care Unit', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'infoTypes': ['SAP', 'ICF'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Mr.', 'investigatorFullName': 'SELMAN KILIÇ', 'investigatorAffiliation': 'Hacettepe University'}}}}