Ignite Creation Date:
2025-12-25 @ 1:07 AM
Ignite Modification Date:
2025-12-25 @ 11:19 PM
Study NCT ID:
NCT03430193
Status:
UNKNOWN
Last Update Posted:
2021-01-15
First Post:
2018-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fragility Fracture Integrated Rehabilitation Management (FIRM)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006620', 'term': 'Hip Fractures'}], 'ancestors': [{'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 288}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-14', 'studyFirstSubmitDate': '2018-01-05', 'studyFirstSubmitQcDate': '2018-02-09', 'lastUpdatePostDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Mortality', 'timeFrame': '0, 3 month, 6 month, 12 month', 'description': 'Mortality rate from number of dead patients among enrolled for the study'}, {'measure': 'Recovery to premorbid ambulatory status', 'timeFrame': '0, 3 month, 6 month, 12 month', 'description': 'Comparison premorbid ambulatory status with post-rehabilitation ambulatory status at each follow-up period'}], 'primaryOutcomes': [{'measure': 'Change from baselines mobility status (Functional Ambulatory Category (FAC)) after rehabilitation', 'timeFrame': '0, 3 month, 6 month, 12 month', 'description': 'range, 0 to 5; decreasingly worse'}], 'secondaryOutcomes': [{'measure': 'Change from baselines mobility status (KOVAL) after rehabilitation', 'timeFrame': '0, 3 month, 6 month, 12 month', 'description': 'range, 1 to 7; increasingly worse'}, {'measure': 'Change from baselines mobility status (Functional Independence Measure (FIM)- locomotion) after rehabilitation', 'timeFrame': '0, 3 month, 6 month, 12 month', 'description': 'range, 1 to 7; decreasingly worse'}, {'measure': 'Change from baselines balance and fall risk (Berg Balance Scale (BBS)) after rehabilitation', 'timeFrame': '0, 3 month, 6 month, 12 month', 'description': 'range, 0 to 56; decreasingly worse'}, {'measure': 'Change from baselines from cognition (Korean Mini-Mental State Examination (K-MMSE)) after rehabilitation', 'timeFrame': '0, 3 month, 6 month, 12 month', 'description': 'range, 0 to 30; decreasingly worse'}, {'measure': 'Change from baselines from mood (Korean version of the Geriatric Depression Scale (GDS)) after rehabilitation', 'timeFrame': '0, 3 month, 6 month, 12 month', 'description': 'range, 0 to 30 ; increasingly worse'}, {'measure': 'Change from baselines Quality of life (Euro Quality of Life Questionnaire 5-Dimensional Classification (EQ-5D)) after rehabilitation', 'timeFrame': '0, 3 month, 6 month, 12 month', 'description': 'range, 0 to 1; decreasingly worse'}, {'measure': 'Change from baselines from activities of daily life (Korean modified Barthel index (K-MBI)) after rehabilitation', 'timeFrame': '0, 3 month, 6 month, 12 month', 'description': 'range, 0 to 100; decreasingly worse'}, {'measure': 'Change from baselines from activities of daily life (Korean instrumental ADL (K-IADL)) after rehabilitation', 'timeFrame': '0, 3 month, 6 month, 12 month', 'description': 'range, 0 to 3; increasingly worse'}, {'measure': 'Change from baselines frailty (Korean version of fatigue, resistance, ambulation, illnesses, and loss of weight (FRAIL) scale) after rehabilitation', 'timeFrame': '0, 3 month, 6 month, 12 month', 'description': 'range, 0 to 5; increasingly worse'}, {'measure': 'Change from baselines hand grip strength after rehabilitation', 'timeFrame': '0, 3 month, 6 month, 12 month', 'description': 'measured by a a digital dynamometer (TKK 5401 Grip-D; Takei, Niigata, Japan)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rehabilitation', 'multi-disciplinary rehabilitation', 'clinical pathway', 'Fragility'], 'conditions': ['Hip Fractures']}, 'referencesModule': {'references': [{'pmid': '17074877', 'type': 'BACKGROUND', 'citation': 'Beaupre LA, Cinats JG, Senthilselvan A, Lier D, Jones CA, Scharfenberger A, Johnston DW, Saunders LD. Reduced morbidity for elderly patients with a hip fracture after implementation of a perioperative evidence-based clinical pathway. Qual Saf Health Care. 2006 Oct;15(5):375-9. doi: 10.1136/qshc.2005.017095.'}, {'pmid': '9302897', 'type': 'RESULT', 'citation': 'Lyons AR. Clinical outcomes and treatment of hip fractures. Am J Med. 1997 Aug 18;103(2A):51S-63S; discussion 63S-64S. doi: 10.1016/s0002-9343(97)90027-9.'}, {'pmid': '12777366', 'type': 'RESULT', 'citation': 'Magaziner J, Fredman L, Hawkes W, Hebel JR, Zimmerman S, Orwig DL, Wehren L. Changes in functional status attributable to hip fracture: a comparison of hip fracture patients to community-dwelling aged. Am J Epidemiol. 2003 Jun 1;157(11):1023-31. doi: 10.1093/aje/kwg081.'}, {'pmid': '18070003', 'type': 'RESULT', 'citation': "Sellier E, Labarere J, Sevestre MA, Belmin J, Thiel H, Couturier P, Bosson JL; Association pour la Promotion de l'Angiologie Hospitaliere. Risk factors for deep vein thrombosis in older patients: a multicenter study with systematic compression ultrasonography in postacute care facilities in France. J Am Geriatr Soc. 2008 Feb;56(2):224-30. doi: 10.1111/j.1532-5415.2007.01545.x. Epub 2007 Dec 7."}, {'pmid': '11386929', 'type': 'RESULT', 'citation': 'Hannan EL, Magaziner J, Wang JJ, Eastwood EA, Silberzweig SB, Gilbert M, Morrison RS, McLaughlin MA, Orosz GM, Siu AL. Mortality and locomotion 6 months after hospitalization for hip fracture: risk factors and risk-adjusted hospital outcomes. JAMA. 2001 Jun 6;285(21):2736-42. doi: 10.1001/jama.285.21.2736.'}, {'pmid': '16606814', 'type': 'RESULT', 'citation': 'Siu AL, Penrod JD, Boockvar KS, Koval K, Strauss E, Morrison RS. Early ambulation after hip fracture: effects on function and mortality. Arch Intern Med. 2006 Apr 10;166(7):766-71. doi: 10.1001/archinte.166.7.766.'}, {'pmid': '16278174', 'type': 'RESULT', 'citation': 'Koval KJ, Cooley MR. Clinical pathway after hip fracture. Disabil Rehabil. 2005 Sep 30-Oct 15;27(18-19):1053-60. doi: 10.1080/09638280500056618.'}, {'pmid': '17724548', 'type': 'RESULT', 'citation': 'Halbert J, Crotty M, Whitehead C, Cameron I, Kurrle S, Graham S, Handoll H, Finnegan T, Jones T, Foley A, Shanahan M; Hip Fracture Rehabilitation Trial Collaborative Group. Multi-disciplinary rehabilitation after hip fracture is associated with improved outcome: A systematic review. J Rehabil Med. 2007 Sep;39(7):507-12. doi: 10.2340/16501977-0102.'}, {'pmid': '12807926', 'type': 'RESULT', 'citation': 'Adunsky A, Lusky A, Arad M, Heruti RJ. A comparative study of rehabilitation outcomes of elderly hip fracture patients: the advantage of a comprehensive orthogeriatric approach. J Gerontol A Biol Sci Med Sci. 2003 Jun;58(6):542-7. doi: 10.1093/gerona/58.6.m542.'}, {'pmid': '29768364', 'type': 'DERIVED', 'citation': 'Lee SY, Beom J, Kim BR, Lim SK, Lim JY; Fragility Fracture Rehabilitation Study Group. Comparative effectiveness of fragility fracture integrated rehabilitation management for elderly individuals after hip fracture surgery: A study protocol for a multicenter randomized controlled trial. Medicine (Baltimore). 2018 May;97(20):e10763. doi: 10.1097/MD.0000000000010763.'}]}, 'descriptionModule': {'briefSummary': 'A number of studies for clinical pathway (CP) after hip fracture have been suggested to improve post-fracture outcome. However, CP is not carried out properly in most countries due to inadequate system and awareness, and lack of interdisciplinary approach among orthopaedists, geriatricians and rehabilitation specialists. Thus, we developed Fragility fracture integrated rehabilitation management (FIRM), a new standardized guideline and the multidisciplinary fragility fracture care based on the clinical rehabilitation pathway and conducted a prospective study to evaluate the effects of FIRM compared to conventional rehabilitation.', 'detailedDescription': 'The purpose of this prospective study\n\nTo develop a standardized fragility fracture integrated rehabilitation management (FIRM) based on the critical rehabilitation pathway for fragility fractures.\n\n1. Standardization of initial evaluation for fall and re-fracture risks before rehabilitation\n2. Standardization in initial screening for prevention for common complication after fracture and early diagnosis\n3. Evidence based standardization in rehabilitation after fragility fracture\n4. Development for safe return to normal daily life'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Type of fracture : Femoral neck, intertrochanteric, subtrochanteric fracture\n2. Type of surgery : Bipolar hemiarthroplasty, THA, ORIF\n\nExclusion Criteria:\n\n1. Surgery not for hip fracture, but for infection, arthritis, implant loosening, AVN\n2. Femur Shaft fracture, acetabular fracture, periprosthetic fracture, pathologic fracture for tumor\n3. Combined multiple fracture (ex. Upper extremity)\n4. Revision operation\n5. Disagree to participation for clinical trial\n6. Severe cognitive dysfunction (Obey command ≤1)'}, 'identificationModule': {'nctId': 'NCT03430193', 'acronym': 'FIRM', 'briefTitle': 'Fragility Fracture Integrated Rehabilitation Management (FIRM)', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'Comparative Effectiveness Research of Rehabilitation Methods and Prevention of Refracture After Fractures in Elderly Patients', 'orgStudyIdInfo': {'id': 'HC15C1189'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FIRM group', 'description': 'FIRM program consisted of total 10 days session including PT, in two times twenty-minute sessions per day and 4 times OT during admission initiated before transfer to rehabilitation ward. PT (Weight bearing exercise, strengthening exercise, gait training, aerobic exercise and functional training) progressed gradually based on individual functional level and OT of activities of daily life (ADL) training (transfer, sit to stand, bed mobility, dressing, self-care retraining and using adaptive equipment) was provided.', 'interventionNames': ['Other: FIRM']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional group', 'description': 'Conventional rehabilitation program consisted of total 10 days session of PT focused on simple standing and gait training, in one time twenty-minute sessions per day.', 'interventionNames': ['Other: Conventional rehabilitation']}, {'type': 'NO_INTERVENTION', 'label': 'No-rehabilitation group', 'description': 'Discharged patients not transferred to rehabilitation unit after surgery for hip fracture.'}], 'interventions': [{'name': 'FIRM', 'type': 'OTHER', 'description': 'FIRM program consisted of total 10 days session including PT, in two times twenty-minute sessions per day and 4 times OT during admission initiated before transfer to rehabilitation ward.\n\nPT (Weight bearing exercise, strengthening exercise, gait training, aerobic exercise and functional training) progressed gradually based on individual functional level and OT of activities of daily life (ADL) training (transfer, sit to stand, bed mobility, dressing, self-care retraining and using adaptive equipment) was provided.', 'armGroupLabels': ['FIRM group']}, {'name': 'Conventional rehabilitation', 'type': 'OTHER', 'description': 'Conventional rehabilitation program consisted of total 10 days session of PT focused on simple standing and gait training, in one time twenty-minute sessions per day.', 'armGroupLabels': ['Conventional group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '463-707', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jae-Young Lim, MD, PhD', 'role': 'CONTACT', 'email': 'jaden.lim@gmail.com', 'phone': '+82317877732'}, {'name': 'Seung-Kyu Lim, MD', 'role': 'CONTACT', 'email': 'flyingmango77@gmail.com', 'phone': '+821096045700'}, {'name': 'Jae-Young Lim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Seung-Kyu Lim, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'centralContacts': [{'name': 'Seung-Kyu Lim, MD', 'role': 'CONTACT', 'email': 'flyingmango77@gmail.com', 'phone': '+821096045700'}, {'name': 'Bo-Ram KIM', 'role': 'CONTACT', 'email': 'bboram2@gmail.com', 'phone': '+82317877732'}], 'overallOfficials': [{'name': 'Jae-Young Lim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Korea Health Industry Development Institute', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Department of Rehabilitation Medicine', 'investigatorFullName': 'Jae-Young Lim', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}