Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2026-03-26 @ 1:18 PM
Study NCT ID:
NCT01845766
Status:
COMPLETED
Last Update Posted:
2016-04-13
First Post:
2013-04-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Early Exercise Rehabilitation on Long-term Functional Recovery in Patients With Severe Sepsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D012772', 'term': 'Shock, Septic'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005081', 'term': 'Exercise Therapy'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-11', 'studyFirstSubmitDate': '2013-04-30', 'studyFirstSubmitQcDate': '2013-05-01', 'lastUpdatePostDateStruct': {'date': '2016-04-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severe functional disability', 'timeFrame': '6 months after enrollment', 'description': 'We will assess the functional activity with 0-11 score of 6 ADL(walking, dressing, bathing, eating, getting into and out of bed, toileting) and 5 IADL(preparing a hot meal, shopping for groceries, making telephone calls, taking medicines, managing money). If the patient has a score 4 or more, the patient will be considered to have a severe functional disability.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['sepsis, septic shock, rehabilitation, exercise'], 'conditions': ['Severe Sepsis or Septic Shock']}, 'descriptionModule': {'briefSummary': 'We hypothesized that early exercise rehabilitation for patients with severe sepsis or septic shock would decrease their functional disability and cognitive impairment. We plan to enroll patients with severe sepsis and septic shock who admitted an urban teaching hospital in Seoul, South Korea via ER. We will randomize those subjects into the intervention group which will take a standardized rehabilitation with routine clinical care for sepsis and the control group which will take routine clinical care for sepsis. And, we plan to assess their functional activity using ADL, IADL and SF-36, and cognitive function using MMSE at the time of enrollment, 28 days, and 6 months later.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. age ≥20;\n2. confirmed or suspected infection;\n3. two or more among 1)-4) 1) body temperature \\>38˚C or \\<36˚C 2) heart rate \\>90/min 3) respiratory rate \\>20/min or PaCO2\\<32 mmHg 4) WBC \\>12000/mm3, \\<4000/mm3, or band forms \\>10%;\n4. within 48 hours after arriving ER\n\nExclusion Criteria:\n\n1. severe functional disability before admission;\n2. central nervous system infection;\n3. contraindication for exercise rehabilitation according to the investigators' decision;\n4. severe medical illness or mental problem or laboratory abnormality which can confound the results;\n5. pregnancy"}, 'identificationModule': {'nctId': 'NCT01845766', 'briefTitle': 'Effects of Early Exercise Rehabilitation on Long-term Functional Recovery in Patients With Severe Sepsis', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '4-2012-0710'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'rehabilitation arm', 'description': 'daily standardized exercise rehabilitation during the admission period, and daily standardized self exercise after discharge', 'interventionNames': ['Other: exercise rehabilitation']}, {'type': 'NO_INTERVENTION', 'label': 'control arm'}], 'interventions': [{'name': 'exercise rehabilitation', 'type': 'OTHER', 'armGroupLabels': ['rehabilitation arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}