Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-25 @ 9:15 PM
Study NCT ID:
NCT01379456
Status:
COMPLETED
Last Update Posted:
2019-11-21
First Post:
2011-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Eva-Hip, Evaluation of Rehabilitation After Hip-fracture
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 223}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-19', 'studyFirstSubmitDate': '2011-06-15', 'studyFirstSubmitQcDate': '2011-06-21', 'lastUpdatePostDateStruct': {'date': '2019-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in gait speed', 'timeFrame': '4,6 and 12 months postfracture'}], 'secondaryOutcomes': [{'measure': 'change in activity level', 'timeFrame': '4,6 and 12 month postfracture'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hip Fracture']}, 'referencesModule': {'references': [{'pmid': '24996117', 'type': 'BACKGROUND', 'citation': 'Thingstad P, Taraldsen K, Hagen G, Sand S, Saltvedt I, Sletvold O, Helbostad JL. Effectiveness of task specific gait and balance exercise 4 months after hip fracture: protocol of a randomized controlled trial--the Eva-hip study. Physiother Res Int. 2015 Jun;20(2):87-99. doi: 10.1002/pri.1599. Epub 2014 Jul 3.'}, {'pmid': '28929932', 'type': 'BACKGROUND', 'citation': 'Hektoen LF, Saltvedt I, Sletvold O, Helbostad JL, Luras H, Halsteinli V. One-year health and care costs after hip fracture for home-dwelling elderly patients in Norway: Results from the Trondheim Hip Fracture Trial. Scand J Public Health. 2016 Dec;44(8):791-798. doi: 10.1177/1403494816674162. Epub 2016 Oct 23.'}, {'pmid': '31738792', 'type': 'RESULT', 'citation': 'Taraldsen K, Thingstad P, Dohl O, Follestad T, Helbostad JL, Lamb SE, Saltvedt I, Sletvold O, Halsteinli V. Short and long-term clinical effectiveness and cost-effectiveness of a late-phase community-based balance and gait exercise program following hip fracture. The EVA-Hip Randomised Controlled Trial. PLoS One. 2019 Nov 18;14(11):e0224971. doi: 10.1371/journal.pone.0224971. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the effect on gait and activity of a home based physiotherapy intervention 4-6 months after the fracture. The investigators hypothesis is that exercises performed after the initial rehabilitation, which focuses on specific components of gait control will improve gait and increase level of activity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Home dwelling prior to fracture\n* age\\>70yr\n* able to walk 10m\n\nExclusion Criteria:\n\n* expected life expectancies \\<3 months\n* exercises contraindicated due to medical conditions'}, 'identificationModule': {'nctId': 'NCT01379456', 'acronym': 'Eva-Hip', 'briefTitle': 'Eva-Hip, Evaluation of Rehabilitation After Hip-fracture', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'The Effect on Gait and Activity Level of a Physiotherapy Intervention Aimed at Improving Mediolateral Stability 4 Months After a Hip Fracture', 'orgStudyIdInfo': {'id': 'REK 2010/3265-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'physiotherapy', 'description': 'exercises', 'interventionNames': ['Procedure: physiotherapy']}, {'type': 'NO_INTERVENTION', 'label': 'conventional treatment', 'description': 'care as usual'}], 'interventions': [{'name': 'physiotherapy', 'type': 'PROCEDURE', 'description': 'exercises, 20 sessions over 10 weeks', 'armGroupLabels': ['physiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7006', 'city': 'Trondheim', 'country': 'Norway', 'facility': 'Norwegian University of Science and Technology', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Olav Sletvold, MD,PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Neuroscience, Norwegian University of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'Trondheim Kommune', 'class': 'OTHER'}, {'name': 'Norsk kvinners sanitetsforening', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}