Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 3:11 AM
Study NCT ID:
NCT07427758
Status:
RECRUITING
Last Update Posted:
2026-02-23
First Post:
2026-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Cognitive Behavioral Therapy on Kinesiophobia and Functional Outcomes After Total Hip Arthroplasty.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092442', 'term': 'Kinesiophobia'}], 'ancestors': [{'id': 'D010698', 'term': 'Phobic Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'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': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-17', 'studyFirstSubmitDate': '2026-02-17', 'studyFirstSubmitQcDate': '2026-02-17', 'lastUpdatePostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tampa Scale of kinesiophobia (TSK)', 'timeFrame': 'Day 1 , 6 weeks , 12 weeks, 6 months as follow up.', 'description': 'To assess kinesiophobia ( fear of movement/re-injury) before and after intervention ( at four time points ).This scale uses individual item scores ranging from 1 to 4, where 1 indicates strong disagreement and 4 indicates strong agreement. Four negatively worded items (4, 8, 12, 16) are reverse-scored (4 = 1, 3 = 2, 2 = 3, 1 = 4). The total score ranges from 17 to 68, with higher scores indicating greater kinesiophobia. Scores above 37 are generally considered indicative of clinically relevant kinesiophobia'}], 'secondaryOutcomes': [{'measure': 'Numerical Pain Rating Scale Score (NPRS)', 'timeFrame': 'day 1 , 6 weeks , 12 weeks, 6 months as follow up', 'description': 'To evaluate the effect of Cognitive Behavioral Therapy on pain perception. Scores range from 0 ( no pain) to 10 (worst pain)'}, {'measure': 'Harris Hip Score (HHS)', 'timeFrame': 'day 1 , 6weeks , 12 weeks , 6 months as follow up', 'description': 'To assess hip function, pain, and functional mobility on day 1 , 6weeks , 12 weeks , 6 months after surgery 90-100: excellent 80-89: good 70-79: fair \\<70: poor'}, {'measure': 'Assessmeny of qulity of life by SF-36 Form', 'timeFrame': 'day 1, 6weeks , 12 weeks and 6 months as follow up.', 'description': 'To assess overall health-related quality of life on day 1, 6weeks , 12 weeks and 6 months after surgery. Scores range from 0 ( lowest score )-100 (highest score), with :\n\nHigher scores: better health status and functioning Lower scores: worse health status and functioning'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Total Hip Arthroplasty', 'Kinesiophobia (fear of movement)'], 'conditions': ['Total Hip Arthroplasty (THA)', 'Kinesiophobia (Fear of Movement)']}, 'referencesModule': {'references': [{'pmid': '30705547', 'type': 'BACKGROUND', 'citation': 'Kumar P, Sen R, Aggarwal S, Agarwal S, Rajnish RK. Reliability of Modified Harris Hip Score as a tool for outcome evaluation of Total Hip Replacements in Indian population. J Clin Orthop Trauma. 2019 Jan-Feb;10(1):128-130. doi: 10.1016/j.jcot.2017.11.019. Epub 2017 Dec 6.'}, {'pmid': '36917768', 'type': 'BACKGROUND', 'citation': 'Dupuis F, Cherif A, Batcho C, Masse-Alarie H, Roy JS. The Tampa Scale of Kinesiophobia: A Systematic Review of Its Psychometric Properties in People With Musculoskeletal Pain. Clin J Pain. 2023 May 1;39(5):236-247. doi: 10.1097/AJP.0000000000001104.'}, {'pmid': '1285753', 'type': 'BACKGROUND', 'citation': "Brazier JE, Harper R, Jones NM, O'Cathain A, Thomas KJ, Usherwood T, Westlake L. Validating the SF-36 health survey questionnaire: new outcome measure for primary care. BMJ. 1992 Jul 18;305(6846):160-4. doi: 10.1136/bmj.305.6846.160."}, {'pmid': '23190932', 'type': 'BACKGROUND', 'citation': 'Monaghan B, Grant T, Hing W, Cusack T. Functional exercise after total hip replacement (FEATHER): a randomised control trial. BMC Musculoskelet Disord. 2012 Nov 28;13:237. doi: 10.1186/1471-2474-13-237.'}, {'pmid': '35968616', 'type': 'BACKGROUND', 'citation': 'Al-Amiry B, Rahim A, Knutsson B, Mattisson L, Sayed-Noor A. Kinesiophobia and its association with functional outcome and quality of life 6-8 years after total hip arthroplasty. Acta Orthop Traumatol Turc. 2022 Jul;56(4):252-255. doi: 10.5152/j.aott.2022.21318.'}, {'pmid': '40565392', 'type': 'BACKGROUND', 'citation': 'Marmouta P, Marmouta L, Tsounis A, Tzavara C, Malliarou M, Fradelos E, Saridi M, Toska A, Sarafis P. Effect of Kinesiophobia and Social Support on Quality of Life After Total Hip Arthoplasty. Healthcare (Basel). 2025 Jun 6;13(12):1366. doi: 10.3390/healthcare13121366.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial study is to evaluate the effectiveness of cognitive behavioral therapy in reducing kinesiophobia and improving Clinical outcomes in postoperative patients following total hip arthroplasty The main question it aims to answer is:\n\nDoes the addition of cognitive behavioral therapy to standard physical therapy rehabilitation exercise reduce kinesiophobia and pain while improving functional mobility and quality of life in postoperative patients after total hip arthroplasty ? Participants will be divided into two groups to be compared: the first group (Control group) will only receive standard physical therapy rehabilitation exercises , consistent with routine post-total hip arthroplasty care, while the second group ( experimental group) will receive the same program in addition to cognitive behavioral therapy.', 'detailedDescription': 'Cognitive behavioral therapy is a psychological therapy that helps individuals modify unhelpful thoughts and behaviors to improve emotions and functioning (American Psychological Association , 2017). Emerging studies have shown that cognitive behavioral therapy is effective in reducing kinesiophobia in postoperative patients after joint athroplasty , with recent evidence specifically in total knee arthroplasty (Sun Et al.,2020).\n\nThus ,the investigators hypothesize that adding cognitive behavioral therapy (CBT) to a standard physical therapy rehabilitation program will improve kinesiophobia and clinical outcomes after total hip arthroplasty.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n((1) postoperative unilateral THA for the first time; (2) at least primary education; (3) ≥18 years of age ; (4) voluntary participation and close cooperation with the care plan; and (5) agreement to continue the intervention and the six-month follow-up after discharge,(6) high level of kinesiophobia on Tampa Scale of Kinesiophobia(TSK), (7)medically stable and cleared by their orthopedic surgeon.\n\nExclusion Criteria:\n\n(1) revision surgery, (2) severe osteoarthritis in the contralateral hip, (3) severe acute metabolic neuromuscular and cardiovascular disease, (4) body mass index above 40, (5) presence of malignancy, any other orthopedic or neurologic problem that might affect treatment and assessments, (6) any condition that might interfere with communication, (7) or lack of cooperation during the study.(9) Individuals with cognitive disorder,(10) individuals with any psychological disease or disorder,(10) Had previously participated in a CBT intervention,(11) pregnancy.'}, 'identificationModule': {'nctId': 'NCT07427758', 'briefTitle': 'Effect of Cognitive Behavioral Therapy on Kinesiophobia and Functional Outcomes After Total Hip Arthroplasty.', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Cognitive Behavioral Therapy on Kinesiophobia and Clinical Outcomes After Total Hip Arthroplasty: A Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'Cognitive Behavioral Therapy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Total Hip Arthroplasty Rehabilitation', 'description': 'Standard Total Hip Arthroplasty Rehabilitation will only receive standard THA rehabilitation exercises , consistent with routine post- total hip arthroplasty care.\n\nThe program consists of active exercises aimed at restoring mobility , improving strength and movement control and enhancing performance of daily activities during the early postoperative phase', 'interventionNames': ['Other: Exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Cognitive Behavioral Therapy with standard THA rehabilitation', 'description': 'The experimental group will receive CBT sessions in addition to the same standard THA rehabilitation exercises delivered to the control group. The cognitive behavioral therapy intervention comprised structured sessions focusing on the identification and modification of maladaptive beliefs related to pain and movement, education regarding postoperative pain, and the development of adaptive coping strategies. The program incorporated cognitive restructuring, graded exposure to functional activities, behavioral activation, and relaxation techniques to reduce kinesiophobia, address fear-avoidance behaviors, and support functional recovery and self-efficacy throughout rehabilitation.', 'interventionNames': ['Behavioral: Cognitive-behavioral therapy', 'Other: Exercise']}], 'interventions': [{'name': 'Cognitive-behavioral therapy', 'type': 'BEHAVIORAL', 'description': 'Four Cognitive Behavioral Therapy sessions will be delivered over a 12-week period.', 'armGroupLabels': ['Cognitive Behavioral Therapy with standard THA rehabilitation']}, {'name': 'Exercise', 'type': 'OTHER', 'description': 'The Standard rehabilitation program consisting of active exercises will be delivered over a 12-week period', 'armGroupLabels': ['Cognitive Behavioral Therapy with standard THA rehabilitation', 'Standard Total Hip Arthroplasty Rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2356', 'city': 'Giza', 'state': 'Giza Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed ElMelhat, PhD', 'role': 'CONTACT', 'email': 'ahmed.elmelhat@cu.edu.eg', 'phone': '01112595022'}], 'facility': 'Cairo University Hospitals', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'centralContacts': [{'name': 'Ahmad El Melhat, Phd', 'role': 'CONTACT', 'email': 'ahmed.elmelhat@cu.edu.lb', 'phone': '+20 11 12595022'}, {'name': 'Sara Ahmad Manasfi, BSc', 'role': 'CONTACT', 'email': 'sarahms611998@gmail.com', 'phone': '+961 76806944'}], 'overallOfficials': [{'name': 'Ahmed El Melhat, Phd', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Physical Therapy at Beirut Arab University and Cairo University', 'investigatorFullName': 'Ahmed ElMelhat', 'investigatorAffiliation': 'Cairo University'}}}}