Effect of Cognitive Behavioral Therapy on Kinesiophobia and Functional Outcomes After Total Hip Arthroplasty.

NCT07427758 | Recruiting DMC

• 1 other identifier: Cognitive Behavioral Therapy
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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: Does 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.

Conditions

Total Hip Arthroplasty (THA); Kinesiophobia (Fear of Movement)

Keywords

Total Hip Arthroplasty; Kinesiophobia (fear of movement)

Outcome Measures

Primary Outcomes (1)

• Tampa Scale of kinesiophobia (TSK)

  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

  Day 1 , 6 weeks , 12 weeks, 6 months as follow up.

Secondary Outcomes (3)

• Numerical Pain Rating Scale Score (NPRS)

  day 1 , 6 weeks , 12 weeks, 6 months as follow up

• Harris Hip Score (HHS)

  day 1 , 6weeks , 12 weeks , 6 months as follow up

• Assessmeny of qulity of life by SF-36 Form

  day 1, 6weeks , 12 weeks and 6 months as follow up.

Study Arms (2)

Standard Total Hip Arthroplasty Rehabilitation

ACTIVE COMPARATOR

Standard Total Hip Arthroplasty Rehabilitation will only receive standard THA rehabilitation exercises , consistent with routine post- total hip arthroplasty care. The 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

Other: Exercise

Cognitive Behavioral Therapy with standard THA rehabilitation

EXPERIMENTAL

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.

Behavioral: Cognitive-behavioral therapy; Other: Exercise

Interventions

Cognitive-behavioral therapy BEHAVIORAL

Four Cognitive Behavioral Therapy sessions will be delivered over a 12-week period.

Cognitive Behavioral Therapy with standard THA rehabilitation

Exercise OTHER

The Standard rehabilitation program consisting of active exercises will be delivered over a 12-week period

Cognitive Behavioral Therapy with standard THA rehabilitation; Standard Total Hip Arthroplasty Rehabilitation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ((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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University Hospitals

Giza, Giza Governorate, 2356, Egypt

RECRUITING

Related Publications (6)

• 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: 30705547 BACKGROUND

• 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: 36917768 BACKGROUND

• 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: 1285753 BACKGROUND

• 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: 23190932 BACKGROUND

• 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: 35968616 BACKGROUND

• 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.

  PMID: 40565392 BACKGROUND

MeSH Terms

Conditions

Kinesiophobia

Interventions

Cognitive Behavioral Therapy; Exercise

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ahmed El Melhat, Phd

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Ahmad El Melhat, Phd

CONTACT

+20 11 12595022; ahmed.elmelhat@cu.edu.lb

Sara Ahmad Manasfi, BSc

CONTACT

+961 76806944; sarahms611998@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Physical Therapy at Beirut Arab University and Cairo University

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: February 23, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)