Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-01-01 @ 7:44 AM
Study NCT ID:
NCT04845204
Status:
COMPLETED
Last Update Posted:
2021-04-14
First Post:
2021-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relaxation Treatment in Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-10', 'studyFirstSubmitDate': '2021-04-06', 'studyFirstSubmitQcDate': '2021-04-10', 'lastUpdatePostDateStruct': {'date': '2021-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Level Change', 'timeFrame': 'Mean change from Postoperative day 1 to day 4 recorded', 'description': 'Visual analog scale'}], 'secondaryOutcomes': [{'measure': 'Sleep Quality Change', 'timeFrame': 'Mean change from Postoperative day 1 to day 4 recorded', 'description': 'Visual analog scale'}, {'measure': 'Functional Outcomes Change', 'timeFrame': 'Mean change from Postoperative day4 to 6 weeks following surgery recorded', 'description': 'Timed Up and Go'}, {'measure': 'Functional Outcomes Change', 'timeFrame': 'Mean change from Postoperative day4 to 6 weeks following surgery recorded', 'description': 'Western Ontario McMaster Universities Osteoarthritis Index (WOMAC)'}, {'measure': 'Knee Range of Motion Change', 'timeFrame': 'Mean change from Postoperative day4 to 6 weeks following surgery recorded', 'description': 'Flexion and Extension'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Relaxation; Joint', 'Total Knee Arthroplasty', 'Exercise']}, 'referencesModule': {'references': [{'pmid': '31467645', 'type': 'BACKGROUND', 'citation': 'Koken M, Guclu B. The Effects of Total Knee Arthroplasty on Sleep Quality. Malays Orthop J. 2019 Jul;13(2):11-14. doi: 10.5704/MOJ.1907.002.'}, {'pmid': '27295978', 'type': 'BACKGROUND', 'citation': 'Schache MB, McClelland JA, Webster KE. Does the addition of hip strengthening exercises improve outcomes following total knee arthroplasty? A study protocol for a randomized trial. BMC Musculoskelet Disord. 2016 Jun 13;17:259. doi: 10.1186/s12891-016-1104-x.'}]}, 'descriptionModule': {'briefSummary': 'Surgical techniques and treatment methods of the arthroplasty have been improved and the results after total knee arthroplasty (TKA) are generally good. However, some patients have suboptimal postoperative results with respect to pain and physical functioning and may not be satisfied with the results of their TKA. Psychological symptoms were found to be associated with these suboptimal results. The aim of the present study is to determine weather relaxation techniques had beneficial effects on pain, sleeping quality, functional status and physiological symptoms in TKA patients during their hospital stay.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* primary knee osteoarthritis, Female Patients who are scheduled for unilateral Total Knee Arthroplasty surgery, were included in the study.\n\nExclusion Criteria:\n\n* having a previous knee or hip surgery or fracture, diagnosis of rheumatoid arthritis, severe obesity (BMI\\>40 kg/m2), sensory and motor disorders in the operated limb, inability to understand pain assessment.'}, 'identificationModule': {'nctId': 'NCT04845204', 'briefTitle': 'Relaxation Treatment in Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Effects of Progressive Muscle Relaxation Techniques on Pain, Sleeping Quality and Functional Levels After Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': 'GO 15/77-22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Relaxation Treatment', 'description': 'Relaxation treatment (RT) is applied additional to standard physiotherapy treatment. RT includes 8 sessions (2 times a day, for four days after surgery) of relaxation exercises.', 'interventionNames': ['Other: Standard Exercises']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Exercises', 'description': 'Standard postoperative rehabilitation program is applied to Control Group. Knee-based exercises were undertaken in supine (active- assisted knee flexion using a bandage, inner range quadriceps contractions, and straight-leg raises), seated (active-assisted knee flexion using the contralateral limb and inner range quadriceps contractions), and standing (hip and knee flexion, active hamstring curls, lunges on a step, hamstring stretches) postures.', 'interventionNames': ['Other: Relaxation Treatment']}], 'interventions': [{'name': 'Relaxation Treatment', 'type': 'OTHER', 'otherNames': ['Standard Exercises'], 'description': 'Relaxation Group recieve progressive muscle relaxation exercises additional to the standard exercises. The relaxation exercises are applied two times a day till the discharge day starting on the postoperative day one. Progressive muscle relaxation included the relaxing of different muscle groups along with deep breathing. The maximal contraction period consist of the contraction of muscle groups around ankle, calf, knee, hip, lumbar, thoracic and cervical regions, shoulder, arm, forearm for 5 s and continued with a relaxation period for 30 s while focusing on breathing. These two periods ware repeated for each muscle groups and lasted approximately 30 min', 'armGroupLabels': ['Standard Exercises']}, {'name': 'Standard Exercises', 'type': 'OTHER', 'otherNames': ['Relaxation Treatment'], 'description': 'The physiotherapy protocol is applied under the supervision of the same physiotherapist within a progressive manner immediately after surgery. Continued passive range of motion is applied twice a day starting with 45ยบ of knee flexion range of motion and increased gradually as tolerated. All patients performed same isometric, isotonic and active exercises. Patients were instructed to bear weight as tolerated on the postoperative day 1', 'armGroupLabels': ['Relaxation Treatment']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'HANDE GUNEY', 'investigatorAffiliation': 'Hacettepe University'}}}}