Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2026-03-05 @ 8:34 AM
Study NCT ID:
NCT05892133
Status:
RECRUITING
Last Update Posted:
2023-12-15
First Post:
2023-05-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prehabilitation Effect on Function and Patient Satisfaction Following Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], '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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-08', 'studyFirstSubmitDate': '2023-05-03', 'studyFirstSubmitQcDate': '2023-06-06', 'lastUpdatePostDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Leg press strength', 'timeFrame': 'Baseline, 1 week pre-surgery, 3week post-surgery, 12 months post-surgery.', 'description': 'The maximal weight that can be lifted once'}, {'measure': 'Group differences in Patient satisfaction', 'timeFrame': 'Change from 3 week post-surgery, 12 months post-surgery.', 'description': 'Satisfied with the results of knee surgery: yes/no'}], 'secondaryOutcomes': [{'measure': 'Change in Voluntary activation', 'timeFrame': 'Baseline, 1 week pre-surgery, 3week post-surgery.', 'description': 'Force production of thigh muscle during contraction with superimposed electrical stimulation'}, {'measure': 'Change in Self reported knee function', 'timeFrame': 'Baseline, 1 week pre-surgery, 3week post-surgery, 12 months post-surgery.', 'description': 'The Knee Injury and Osteoarthritis Outcome Score - Physical Function - Short Form'}, {'measure': 'Change in Walking speed', 'timeFrame': 'Baseline, 1 week pre-surgery, 3week post-surgery, 12 months post-surgery.', 'description': '10 meter walking test'}, {'measure': 'Change in Chair rising ability', 'timeFrame': 'Baseline, 1 week pre-surgery, 3week post-surgery, 12 months post-surgery.', 'description': '30 second sit to stand test'}, {'measure': 'Change in Balance', 'timeFrame': 'Baseline, 1 week pre-surgery, 3week post-surgery, 12 months post-surgery.', 'description': 'unipedal stance test, postural sway'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prehabilitation', 'Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Knee arthrosis has a high prevalence. Non-surgical treatment, such as exercise, is the first choice of treatment. However, most patients end up having a surgical procedure such as total knee arthroplasty. Following surgery with total knee replacement as much as 20% of patients report to not be satisfied with the results. It is noteworthy that this level of dissatisfaction has persisted over the last decades despite formidable progress in surgical methods and technology. Leg strength prior to surgery is associated with faster recovery post operatively, which may influence satisfaction. The investigators aim is to implement a period of strength training prior to surgery to evaluate if training prior to surgery may reduce the level of dissatisfaction post operatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Knee artrosis, refered to surgery\n\nExclusion Criteria:\n\n* Kognitive disability\n* Inflamatory disease in muscles\n* varus/ valgus and extension deficit \\>15 degrees\n* Neurological disorders'}, 'identificationModule': {'nctId': 'NCT05892133', 'briefTitle': 'Prehabilitation Effect on Function and Patient Satisfaction Following Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Molde University College'}, 'officialTitle': 'Prehabilitation Effect on Function and Patient Satisfaction Following Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': '522685'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Maximal strength training', 'description': 'eight weeks of leg press strength training prior to knee surgery', 'interventionNames': ['Behavioral: Maximal strength training']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'treatment as usual prior to knee surgery'}], 'interventions': [{'name': 'Maximal strength training', 'type': 'BEHAVIORAL', 'description': '3 sessions/ week. leg press at \\~85% of one repetition maximum for 8 weeks', 'armGroupLabels': ['Maximal strength training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6410', 'city': 'Molde', 'state': 'Møre og Romsdal', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Ole Kristian Berg, Dr.', 'role': 'CONTACT', 'email': 'olbe@himolde.no', 'phone': '+47 71 19 57 71'}], 'facility': 'Molde University College', 'geoPoint': {'lat': 62.73752, 'lon': 7.15912}}], 'centralContacts': [{'name': 'Berg', 'role': 'CONTACT', 'email': 'olbe@himolde.no', 'phone': '+47 71 19 57 71'}], 'overallOfficials': [{'name': 'Berg', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Molde UC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Molde University College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}