Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-01-01 @ 8:05 PM
Study NCT ID:
NCT00896259
Status:
COMPLETED
Last Update Posted:
2012-08-29
First Post:
2009-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of a Late Phase Exercise Program Following Total Hip Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-28', 'studyFirstSubmitDate': '2009-05-08', 'studyFirstSubmitQcDate': '2009-05-08', 'lastUpdatePostDateStruct': {'date': '2012-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hip muscle strength', 'timeFrame': '8-12 weeks post THA, 6-7 months post THA'}], 'secondaryOutcomes': [{'measure': 'Gait', 'timeFrame': '8-12 weeks post THA, 6-7 months post THA'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Unilateral total hip arthroplasty'], 'conditions': ['Total Hip Arthroplasty']}, 'descriptionModule': {'briefSummary': "A group of orthopedic physiotherapists have developed a late phase program to educate and instruct total hip replacement patients in progressive exercises appropriate for their level of recovery. The components of this program include an educational presentation, individual assessment and exercise prescription. The investigators' intent is to pilot the program using a sample of patients. The objective of this pilot project:\n\nTo examine the effects of the late phase education session and home-based exercise program in restoring hip muscle strength, gait and function"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'orthopedic clinic outpatients (of one clinic)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* unilateral primary total hip arthroplasty (THA)\n* 8-12 weeks post THA\n* over the age of 18\n* able to walk 15m without a walking aid\n* able to participate in an exercise program without physical assistance\n* available for follow up as per the study protocol\n* able to read and understand English and follow verbal and visual instructions\n\nExclusion Criteria:\n\n* medically unstable\n* have central or peripheral nervous system deficits\n* have an underlying terminal disease (cancer)\n* have suspicion of infection following joint replacement'}, 'identificationModule': {'nctId': 'NCT00896259', 'briefTitle': 'Effects of a Late Phase Exercise Program Following Total Hip Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Nova Scotia Health Authority'}, 'officialTitle': 'Effects of a Late Phase Education and Exercise Program Following Total Hip Arthroplasty: A Pilot Project', 'orgStudyIdInfo': {'id': 'CDHA-RS/2007-057'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'THA control', 'description': 'those with THA not participating in exercise and education program'}, {'label': 'THA exercise', 'description': 'those with THA and participating in exercise and education program', 'interventionNames': ['Other: home based exercise and education program']}, {'label': 'healthy control', 'description': 'Healthy control, people with no lower limb gait abnormalities'}], 'interventions': [{'name': 'home based exercise and education program', 'type': 'OTHER', 'description': 'Individual assessment with physiotherapist with educational information, exercise instruction and prescription provided. Instructed to perform home exercises and walking for 12 weeks. Will be individually tailored to participants, bi-monthly phone calls will be used to monitor and facilitate exercise and walking progression .', 'armGroupLabels': ['THA exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B3H 2E1', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Orthopedic Clinic, QEII Health Sciences Centre, CDHA', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}], 'overallOfficials': [{'name': 'Ann Read, BScPT, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CDHA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nova Scotia Health Authority', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Orthopaedic Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Rehabilitation Engineer', 'investigatorFullName': 'Kim Parker', 'investigatorAffiliation': 'Nova Scotia Health Authority'}}}}