An interventional study of Cognitive-behavioral therapy and Exercise in Total Hip Arthroplasty (THA) and Kinesiophobia (Fear of Movement), sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-02-23.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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.
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.
285 studies on the registry are indexed under Kinesiophobia; 91 are open to participants now.
This study's planned enrollment of 100 is above the median of 52 across 174 interventional studies indexed under Kinesiophobia.
Browse Kinesiophobia studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
((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.
Exclusion Criteria:
(1) revision surgery, (2) severe osteoarthritis in the contralateral hip, (3) severe acute metabolic neuromuscular and cardiovascular disease, (4) above 40, (5) presence of , 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Four Cognitive Behavioral Therapy sessions will be delivered over a 12-week period.
The Standard rehabilitation program consisting of active exercises will be delivered over a 12-week period
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
Time frame: Day 1 , 6 weeks , 12 weeks, 6 months as follow up.
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)
Time frame: 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
Time frame: 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
Time frame: day 1, 6weeks , 12 weeks and 6 months as follow up.
Plan to share: No
Started Feb 2026 (actual). Primary completion is estimated for Aug 2026, 6 months after the start.
Of 132 non-industry interventional studies with no phase under Kinesiophobia, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 14. This study's planned 6 months is below that.
Counting every sponsor, half of 132 studies reached it within 8 months; a quarter within 4 and three quarters within 14.
How these figures are worked out, and which studies are left out of them.
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