Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-02-17 @ 11:10 PM
Study NCT ID:
NCT03160534
Status:
COMPLETED
Last Update Posted:
2017-10-23
First Post:
2017-05-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Preoperative Exercise in Patients Undergoing Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082622', 'term': 'Preoperative Exercise'}], 'ancestors': [{'id': 'D019990', 'term': 'Perioperative Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A Randomized Controlled Pilot Trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-19', 'studyFirstSubmitDate': '2017-05-18', 'studyFirstSubmitQcDate': '2017-05-18', 'lastUpdatePostDateStruct': {'date': '2017-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stair climbing test', 'timeFrame': '5 minutes', 'description': 'The stair climbing test (SCT) measures the time used to ascend and descend a flight of twelve steps. Patients are asked to complete the test as quickly as they felt safe and comfortable.'}], 'secondaryOutcomes': [{'measure': 'Knee - Range of Motion', 'timeFrame': '2 minutes', 'description': 'The range of motion of the knee will be assessed.'}, {'measure': 'Tegner Activity Scale and Lysholm Score', 'timeFrame': '10 minutes', 'description': 'The Lysholm score and the Tegner activity scale are widely used for assessing knee function and activity level after knee ligament injuries'}, {'measure': 'Patient Global Impression of Change', 'timeFrame': '2 minutes', 'description': "The self-report measure Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment."}, {'measure': 'Risk of Discharge to a Rehabilitation Facility', 'timeFrame': '20 minutes', 'description': 'Costs and duration of postoperative rehabilitation will be measured with help of a personal calendar. All participants will report on this calendar any post-acute care services after surgery, Costs of skilled nursing facilities, home health agencies, and inpatient rehabilitation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Total Knee Arthroplasty']}, 'referencesModule': {'references': [{'pmid': '32774889', 'type': 'DERIVED', 'citation': 'Granicher P, Stoggl T, Fucentese SF, Adelsberger R, Swanenburg J. Preoperative exercise in patients undergoing total knee arthroplasty: a pilot randomized controlled trial. Arch Physiother. 2020 Aug 5;10:13. doi: 10.1186/s40945-020-00085-9. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the effect of preoperative exercise in patients undergoing a total knee arthroplasty.', 'detailedDescription': 'The objectives of this study were to investigate the effects of a single (9 sessions) prescription community based preoperative physical therapy in patients awaiting a Total Knee Arthroplasty, taking prognostic factors into account.\n\nThe investigators will use different outcome measures to evaluate any possible effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing a Total Knee Arthroplasty\n* Signed informed consent after being informed\n\nExclusion Criteria:\n\n* Acute pain\n* Weakness due to neurological problems\n* Known or suspected non-compliance\n* High BMI \\> 28\n* Patellar residual subluxation\n* High patellar height'}, 'identificationModule': {'nctId': 'NCT03160534', 'briefTitle': 'Effect of Preoperative Exercise in Patients Undergoing Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Balgrist University Hospital'}, 'officialTitle': 'Effect of Preoperative Exercise in Patients Undergoing Total Knee Arthroplasty: A Randomized Controlled Pilot Trial', 'orgStudyIdInfo': {'id': '2015-0472'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Preoperative exercise intervention', 'interventionNames': ['Other: preoperative exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Only measurements'}], 'interventions': [{'name': 'preoperative exercise', 'type': 'OTHER', 'description': 'Each intervention session contains a stretching part and aerobic training', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8008', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Balgrist University Hospital', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Jaap Swanenburg, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Balgrist University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'no there is not'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Balgrist University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}