Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-01-07 @ 7:52 PM
Study NCT ID:
NCT03602105
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-02
First Post:
2018-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Better Before - Better After: Prehabilitation Program for Older Patients Awaiting Total Hip Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 103}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-31', 'studyFirstSubmitDate': '2018-06-06', 'studyFirstSubmitQcDate': '2018-07-25', 'lastUpdatePostDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in gait speed', 'timeFrame': 'Change measure: Baseline, within one week after intervention, 6 weeks after intervention, 3 months after intervention, 6 months after intervention and 12 months after intervention', 'description': '40 meters Fast-Paced Walk test'}], 'secondaryOutcomes': [{'measure': 'Change in physical function', 'timeFrame': 'Change measure: Baseline, within one week after intervention, 6 weeks after intervention, 3 months after intervention, 6 months after intervention and 12 months after intervention', 'description': '30 second sit-to stand test'}, {'measure': 'Change in aerobic capacity', 'timeFrame': '1 week before intervention, directly after intervention as well as 6 and 12 weeks after TJA-surgery', 'description': '6 min walk test'}, {'measure': 'Change in transitional ambulation', 'timeFrame': 'Change measure: Baseline, within one week after intervention, 6 weeks after intervention, 3 months after intervention, 6 months after intervention and 12 months after intervention', 'description': 'Timed-up and go Test (TUG)'}, {'measure': 'Change in pain measured with numeric rating scale (NRS)', 'timeFrame': 'Change measure: Baseline, within one week after intervention, 6 weeks after intervention and 3 months after intervention', 'description': 'NRS - Single score, low score indicates low pain, high score indicated high levels of pain'}, {'measure': 'Length of stay in hospital', 'timeFrame': 'From date of hospital admission until the date of hospital discharge, assessed up to 12 months', 'description': 'Number of days'}, {'measure': 'Change in the ability to climb stairs', 'timeFrame': 'Change measure: Baseline, within one week after intervention, 6 weeks after intervention, 3 months after intervention, 6 months after intervention and 12 months after intervention', 'description': 'Stair-climb test. Timed performance from start to stop'}, {'measure': 'Change in Health Status measured with EuroQol-5 dimensions (EQ-5D)', 'timeFrame': 'Change measure: Baseline, within one week after intervention, 6 weeks after intervention, 3 months after intervention, 6 months after intervention and 12 months after intervention', 'description': 'EQ-5D, five dimensions of health scored from 1-5, with 1 being no problem and 2-5 indicate increasing problem (higher score = increase in problem)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['exercise', 'prehabilitation', 'arthritis', 'quality of life', 'osteoarthritis', 'rehabilitation'], 'conditions': ['Arthritis of Hip']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Slatkowsky-Christensen B, Grotle M. Artrose i Norge. Norsk Epidemiologi 2008;18(1)'}, {'pmid': '28808025', 'type': 'BACKGROUND', 'citation': 'Wallace IJ, Worthington S, Felson DT, Jurmain RD, Wren KT, Maijanen H, Woods RJ, Lieberman DE. Knee osteoarthritis has doubled in prevalence since the mid-20th century. Proc Natl Acad Sci U S A. 2017 Aug 29;114(35):9332-9336. doi: 10.1073/pnas.1703856114. Epub 2017 Aug 14.'}, {'pmid': '19817509', 'type': 'BACKGROUND', 'citation': 'Bitton R. The economic burden of osteoarthritis. Am J Manag Care. 2009 Sep;15(8 Suppl):S230-5.'}, {'pmid': '40050814', 'type': 'DERIVED', 'citation': 'Svinoy OE, Nordbo JV, Pripp AH, Risberg MA, Bergland A, Borgen PO, Hilde G. The effect of prehabilitation for older patients awaiting total hip replacement. A randomized controlled trial with long-term follow up. BMC Musculoskelet Disord. 2025 Mar 6;26(1):227. doi: 10.1186/s12891-025-08468-4.'}, {'pmid': '31892650', 'type': 'DERIVED', 'citation': 'Svinoy OE, Bergland A, Risberg MA, Pripp AH, Hilde G. Better before-better after: efficacy of prehabilitation for older patients with osteoarthritis awaiting total hip replacement-a study protocol for a randomised controlled trial in South-Eastern Norway. BMJ Open. 2019 Dec 30;9(12):e031626. doi: 10.1136/bmjopen-2019-031626.'}]}, 'descriptionModule': {'briefSummary': 'Health professions need to prepare for the large increase in the number of older people with OA requiring health services including TJA surgery. Older age and poor physical function influences the postoperative prognosis of TJA. At discharge from hospital after TJA, studies have shown that gait speed can be severely impaired among older patients.\n\nThe investigators hypothesize that an exercise program of 6-12 weeks will be beneficial for patients that are undergoing TJA.', 'detailedDescription': 'More than 300.000 Norwegians above 20 years of age have osteoarthritis (OA) . There has been a significant increase in the prevalence of OA over the decades. In the United States knee OA affects 19% of adults aged 45 years or older. OA is associated with an extensive high economic and personal burden, largely attributable to the effects of disability, comorbid disease, and the expense of treatment.\n\nGiven the aging population, the number of total joint arthroplasty procedures (TJA) for hip and knee is likely to increase substantially. In light of poor physical function prior to surgery among older patients and the likelihood of an added decrease during hospitalization and risk of poorer outcome after surgery, it is hypothesised that prehabilitation (preoperative exercise) would improve outcomes after surgery, however evidence for its efficacy is still lacking'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants 70 years or older living at home with residential address in the county of Oslo or Akershus scheduled for elective primary total hip replacement due to end-stage osteoarthritis.\n* Harris Hip Score \\>60.\n* Participants must also be capable in Norwegian and be able to follow exercise sessions.\n\nExclusion Criteria:\n\n* Patients with known rheumatoid arthritis or medical contraindications or those who are scheduled for revision of hip arthroplasty\n* Unable to speak and understand the Norwegian language.\n* Patients with neurological disorders affecting gait\n* Medical contraindications for exercise'}, 'identificationModule': {'nctId': 'NCT03602105', 'briefTitle': 'Better Before - Better After: Prehabilitation Program for Older Patients Awaiting Total Hip Replacement', 'organization': {'class': 'OTHER', 'fullName': 'Oslo Metropolitan University'}, 'officialTitle': 'Better Before - Better After: Prehabilitation Program for Older Patients Awaiting Total Hip Replacement. A Randomised Controlled Trial', 'orgStudyIdInfo': {'id': '2018/503'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention group', 'description': 'Exercise interventions for 6-12 weeks. Adherence is monitored with day journals', 'interventionNames': ['Behavioral: Exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Care as usual'}], 'interventions': [{'name': 'Exercise', 'type': 'BEHAVIORAL', 'description': 'Exercises in group and/or individually', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0130', 'city': 'Oslo', 'country': 'Norway', 'facility': 'OsloMet', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Odd-Einar Svinøy, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OsloMet'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo Metropolitan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}