Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2026-01-10 @ 10:03 PM
Study NCT ID:
NCT02498093
Status:
COMPLETED
Last Update Posted:
2020-04-22
First Post:
2015-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maximal Strength Training in Patients Undergoing Total Hip Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018908', 'term': 'Muscle Weakness'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-20', 'studyFirstSubmitDate': '2015-07-08', 'studyFirstSubmitQcDate': '2015-07-13', 'lastUpdatePostDateStruct': {'date': '2020-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscular strength', 'timeFrame': '3 months', 'description': 'leg press (kg), abduction (kg)'}, {'measure': 'Muscular strength', 'timeFrame': '6 months', 'description': 'leg press (kg), abduction (kg)'}, {'measure': 'muscular strength', 'timeFrame': '1 year', 'description': 'leg press (kg), abduction (kg)'}], 'secondaryOutcomes': [{'measure': 'Physical function', 'timeFrame': 'up to 1 year', 'description': 'Harris hip score, 6 min walking test'}, {'measure': 'Bone mineral density', 'timeFrame': 'up to 1 year', 'description': 'Dual X-ray absorptiometry (DXA)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Resistance training', 'Arthroplasty, Replacement, Hip', 'Professional-Patient Relations', 'Evidence-based practice'], 'conditions': ['Muscle Weakness']}, 'referencesModule': {'references': [{'pmid': '32301372', 'type': 'RESULT', 'citation': 'Winther SB, Foss OA, Klaksvik J, Husby VS. Pain and load progression following an early maximal strength training program in total hip- and knee arthroplasty patients. J Orthop Surg (Hong Kong). 2020 Jan-Apr;28(2):2309499020916392. doi: 10.1177/2309499020916392.'}, {'pmid': '29493347', 'type': 'RESULT', 'citation': 'Winther SB, Foss OA, Husby OS, Wik TS, Klaksvik J, Husby VS. A randomized controlled trial on maximal strength training in 60 patients undergoing total hip arthroplasty. Acta Orthop. 2018 Jun;89(3):295-301. doi: 10.1080/17453674.2018.1441362. Epub 2018 Mar 1.'}]}, 'descriptionModule': {'briefSummary': 'Conventional rehabilitation after total hip arthroplasty (THA) does not seem to restore muscular strength or walking speed. Three-5 years after surgery patients are still not fully rehabilitated. This study evaluates the effects of maximal strength training on the muscular strength in leg press and abduction in patients undergoing THA. Aim of the study is to increase the patients physical function through evidence-based rehabilitation in clinical practice, with gradually less supervision.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* scheduled for total hip arthroplasty (THA)\n* living nearby Trondheim\n* diagnosis of primary osteoarthritis as the main cause for elective THA\n* ASA score of I-III (stable)\n\nExclusion Criteria:\n\n* muscular or skeletal disease which might influence the training and/or physical testing performance\n* communication difficulties\n* postoperatively discharged to a rehabilitation institution\n* THA in the bilateral hip that is not fully rehabilitated.'}, 'identificationModule': {'nctId': 'NCT02498093', 'briefTitle': 'Maximal Strength Training in Patients Undergoing Total Hip Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'Maximal Strength Training in Patients Undergoing Total Hip Arthroplasty: Implementing Evidence Based Rehabilitation Into Clinical Practice, and the Influence of Supervised Training', 'orgStudyIdInfo': {'id': '2010/3373'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Maximal strength training', 'description': 'Maximal strength training supervised by a physiotherapist', 'interventionNames': ['Behavioral: Maximal strength training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Conventional rehabilitation supervised by a physiotherapist', 'interventionNames': ['Behavioral: conventional rehabilitation']}], 'interventions': [{'name': 'Maximal strength training', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Maximal strength training']}, {'name': 'conventional rehabilitation', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Trondheim', 'country': 'Norway', 'facility': 'Department of Neuroscience, Faculty of Medicine', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Lars Jacob Stovner, prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Norwegian University of Science and Technology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'St. Olavs Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}