Total Hip Arthroplasty (THA)NCT07427758
Effect of Cognitive Behavioral Therapy on Kinesiophobia and Functional Outcomes After Total Hip Arthroplasty.
A study testing Cognitive-behavioral therapy and Exercise in people with Total Hip Arthroplasty (THA) and Kinesiophobia (Fear of Movement), run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Total Hip Arthroplasty (THA), Kinesiophobia (Fear of Movement)
- What is being tested?
- Cognitive-behavioral therapy and Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2026to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ((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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University Hospitals
Giza, Giza Governorate, 2356
Ahmed ElMelhat, PhD, 01112595022, ahmed.elmelhat@cu.edu.eg
About this study
Official title: Effect of Cognitive Behavioral Therapy on Kinesiophobia and Clinical Outcomes After Total Hip Arthroplasty: A Randomized Controlled Trial.
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.
Read the detailed description
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).
Thus ,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.
- Being tested
- Cognitive-behavioral therapy, Exercise
- Keywords
- Total Hip Arthroplasty, Kinesiophobia (fear of movement)
- Medical subject headings
- Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-behavioral therapyBehavioural
Four Cognitive Behavioral Therapy sessions will be delivered over a 12-week period.
ExerciseOther
The Standard rehabilitation program consisting of active exercises will be delivered over a 12-week period
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: Cognitive-behavioral therapy; Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1 , 6 weeks , 12 weeks, 6 months as follow up.
Secondary outcomes (3)
Numerical Pain Rating Scale Score (NPRS)
To evaluate the effect of Cognitive Behavioral Therapy on pain perception. Scores range from 0 ( no pain) to 10 (worst pain)
Measured: day 1 , 6 weeks , 12 weeks, 6 months as follow up
Harris Hip Score (HHS)
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
Measured: day 1 , 6weeks , 12 weeks , 6 months as follow up
Assessmeny of qulity of life by SF-36 Form
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 :
Higher scores: better health status and functioning Lower scores: worse health status and functioning
Measured: day 1, 6weeks , 12 weeks and 6 months as follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start1 Feb 2026
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Total Hip Arthroplasty (THA)Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed ElMelhat, Cairo University
- Investigators
- Ahmed El Melhat, Phd, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07427758
- Sponsor's protocol ID
- Cognitive Behavioral Therapy
- Status last verified
- Feb 2026
- First submitted
- 17 Feb 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30705547Dupuis 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.
PubMed 36917768Brazier 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.
PubMed 1285753Monaghan 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.
PubMed 23190932Al-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.
PubMed 35968616Marmouta 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.
PubMed 40565392
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cognitive Behavioral Therapy on Kinesiophobia and Clinical Outcomes After Total Hip Arthroplasty: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07427758
- Acronym / sponsor ID
- Cognitive Behavioral Therapy
- Keywords
- Total Hip Arthroplasty, Kinesiophobia (fear of movement)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Thus ,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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Total Hip Arthroplasty Rehabilitation | Active comparator | Other: ExerciseStandard 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 |
| Cognitive Behavioral Therapy with standard THA rehabilitation | Experimental | Behavioral: Cognitive-behavioral therapy, Other: ExerciseThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ((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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-behavioral therapyFour Cognitive Behavioral Therapy sessions will be delivered over a 12-week period. | Behavioural | Cognitive Behavioral Therapy with standard THA rehabilitation |
| ExerciseThe Standard rehabilitation program consisting of active exercises will be delivered over a 12-week period | Other | Cognitive Behavioral Therapy with standard THA rehabilitation, Standard Total Hip Arthroplasty Rehabilitation |
Primary outcome
Tampa Scale of kinesiophobia (TSK)
Time frame: Day 1 , 6 weeks , 12 weeks, 6 months as follow up.
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
3 secondary outcomes
Numerical Pain Rating Scale Score (NPRS)
Time frame: day 1 , 6 weeks , 12 weeks, 6 months as follow up
Harris Hip Score (HHS)
Time frame: day 1 , 6weeks , 12 weeks , 6 months as follow up
Assessmeny of qulity of life by SF-36 Form
Time frame: day 1, 6weeks , 12 weeks and 6 months as follow up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Background: PubMed 30705547Kumar 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.
- Background: PubMed 36917768Dupuis 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.
- Background: PubMed 1285753Brazier 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.
- Background: PubMed 23190932Monaghan 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.
- Background: PubMed 35968616Al-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.
- Background: PubMed 40565392Marmouta 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ahmed El Melhat, Phd study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-behavioral therapy and Exercise in people with Total Hip Arthroplasty (THA) and Kinesiophobia (Fear of Movement), run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmad El Melhat, Phd (+20 11 12595022, ahmed.elmelhat@cu.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tampa Scale of kinesiophobia (TSK) (time frame: Day 1 , 6 weeks , 12 weeks, 6 months as follow up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07427758, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.