Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:37 PM
Study NCT ID:
NCT03584451
Status:
COMPLETED
Last Update Posted:
2018-08-17
First Post:
2018-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Effect of Rehabilitation Sport After Total Hip Arthroplasty (THA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015207', 'term': 'Osteoarthritis, Hip'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-16', 'studyFirstSubmitDate': '2018-06-04', 'studyFirstSubmitQcDate': '2018-07-11', 'lastUpdatePostDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hip-related muscular strength', 'timeFrame': 'change from baseline (6 weeks) at 6 months after THA', 'description': 'hip-related muscular strength measured with isokinetic dynamometry'}], 'secondaryOutcomes': [{'measure': 'Hip pain - WOMAC', 'timeFrame': 'change from 6 months to 12 months after THA', 'description': 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscore (worst=0, best=100)'}, {'measure': 'Physical function hip - WOMAC', 'timeFrame': 'change from 6 months to 12 months after THA', 'description': 'WOMAC Total Score (worst=0, best=100)'}, {'measure': 'Physical function hip - HHS', 'timeFrame': 'change from 6 months to 12 months after THA', 'description': 'Harris-Hip-Score (worst=0, best=100)'}, {'measure': 'Physical Activity', 'timeFrame': 'change from 6 months to 12 months after THA', 'description': 'University of California, Los Angeles (UCLA) Activity Scale (worst=1, best=10)'}, {'measure': 'health related Quality of life', 'timeFrame': 'change from 6 months to 12 months after THA', 'description': 'EuroQol in 5 dimensions (EQ-5D) Index (worst=0, best=1), EQ-VAS (worst=0, best=100)'}, {'measure': 'Hip pain', 'timeFrame': 'change from 6 months to 12 months after THA', 'description': 'Visual Analogue Scale (worst=0, best=10)'}, {'measure': 'cardiovascular endurance', 'timeFrame': 'change from baseline (6 weeks) at 6 months after THA', 'description': 'cardiovascular endurance via lactate measurements'}, {'measure': 'cardiovascular endurance', 'timeFrame': 'change from baseline (6 weeks) at 12 months after THA', 'description': 'cardiovascular endurance via lactate measurements'}, {'measure': 'postural control', 'timeFrame': 'change from baseline (6 weeks) at 6 months after THA', 'description': 'postural control with a force measuring platform'}, {'measure': 'postural control', 'timeFrame': 'change from baseline (6 weeks) at 12 months after THA', 'description': 'postural control with a force measuring platform'}, {'measure': 'hip-related muscular strength', 'timeFrame': 'change from baseline (6 weeks) at 12 months after THA', 'description': 'hip-related muscular strength measured with isokinetic dynamometry'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Total Hip Arthroplasty', 'Osteoarthritis, Hip', 'Sports Physical Therapy']}, 'descriptionModule': {'briefSummary': '160 patients who received a total hip arthroplasty (THA) were included and randomized to receive specific rehabilitation sport (RS) or not (control) in addition to a conventional rehabilitation program. Upon completion of the rehabilitation phase 6 weeks, 6 months and 12 months after surgery sports medical measurements have been performed. Strength abilities of the hip muscles were tested with isokinetic dynamometry, postural control with a force measuring platform and endurance via lactate measurements.', 'detailedDescription': 'In Germany, rehabilitation sport (RS) is a reimbursed postoperative measure in order to support socio-professional reintegration and self-help.\n\n160 patients who received a primary total hip arthroplasty (THA) were included and randomized to receive specific RS or not (control) in addition to a conventional rehabilitation program. Upon completion of the rehabilitation phase 6 weeks, 6 months and 12 months after surgery sports medical measurements have been performed. Strength abilities of the hip muscles were tested with isokinetic dynamometry, postural control with a force measuring platform and endurance via lactate measurements. The goal of the study was to prospectively randomized evaluate the effect of RS on hip-related muscular strength, endurance and postural stability on patients who underwent THA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* non-complicated THA\n* written informed consent\n\nExclusion Criteria:\n\n* complicated THA\n* partial weight-bearing after surgery\n* cardial comorbidities'}, 'identificationModule': {'nctId': 'NCT03584451', 'briefTitle': 'Evaluation of the Effect of Rehabilitation Sport After Total Hip Arthroplasty (THA)', 'organization': {'class': 'OTHER', 'fullName': 'Technische Universität Dresden'}, 'officialTitle': 'Randomized, Clinical Survey for Evaluating the Effect of Rehabilitation Sport on Patients Who Underwent Total Hip Arthroplasty (THA)', 'orgStudyIdInfo': {'id': 'rehasport after THA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'with rehabilitation sport', 'description': 'rehabilitation sport over 52 weeks after THA, start 6 weeks postoperatively', 'interventionNames': ['Behavioral: rehabilitation sport']}, {'type': 'NO_INTERVENTION', 'label': 'without rehabilitation sport', 'description': 'no further rehabilitation program after THA'}], 'interventions': [{'name': 'rehabilitation sport', 'type': 'BEHAVIORAL', 'description': 'rehabilitation Sport over 52 weeks after THA, start 6 weeks postoperatively', 'armGroupLabels': ['with rehabilitation sport']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'no plan to share IPD'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technische Universität Dresden', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}