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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04963361
Other study ID # M2021182
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 25, 2021
Est. completion date September 25, 2021

Study information

Verified date June 2021
Source Peking University Third Hospital
Contact Tao Li
Phone 13811397872
Email tobetheone@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Total knee arthroplasty is one of the effective methods for the treatment of end-stage osteoarthritis. Postoperative rehabilitation exercise is an important method for the recovery of knee joint function. Exercise fear refers to an enlarged psychological phenomenon that patients are afraid of sports leading to injury, which is not conducive to the functional exercise of patients and hinders the recovery of knee joint function


Description:

Object: the purpose of this study is to investigate the occurrence of fear of movement after total knee arthroplasty and analyze its influencing factors, so as to provide theoretical basis for reducing the occurrence of fear of movement after total knee arthroplasty, promoting the rehabilitation exercise of patients and promoting the recovery of knee joint function. In this study, 121 patients with total knee arthroplasty were investigated by questionnaire, including general demographic data, sports fear scale, anxiety and depression scale, self-efficacy scale and so on. Multivariate logistic regression was used to analyze the influencing factors of postoperative fear of exercise.


Recruitment information / eligibility

Status Recruiting
Enrollment 121
Est. completion date September 25, 2021
Est. primary completion date September 25, 2021
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: (1) meeting the criteria of knee arthritis established by American Society of rheumatology ( 2) Total knee arthroplasty was performed for the first time ( 3) Good Chinese reading and comprehension ability ( 4) The patient's condition was stable, and there were no serious diseases of the heart, lung, brain and other important organs ( 5) Informed of the study and signed informed consent. Exclusion Criteria: (1)deep venous thrombosis of lower extremity ( 2) Other diseases affecting walking function ( 3) Suffering from cognitive or mental disorders ( 4) Had a history of knee surgery

Study Design


Related Conditions & MeSH terms


Intervention

Other:
patients were exposed to fear of movement
Patients completed the questionnaires independently
patients were not exposed to fear of movement
Patients completed the questionnaires independently

Locations

Country Name City State
China Peking University Third Hospital Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The occurrence of fear of movement Score of Tampa for kinesiophobia(TSK) ranging from17-68.The higher score means the worse outcome 2nd day post-operative
Secondary Hospital Ansiety and Depression Scale(HADS) The score of HADS ranging from 0-48,the higher score means the worse outcome 2nd day post-operative
Secondary General Self Efficacy Scale(GSES) The score of GSES,ranging from 1-40,the higher socre means the better outcome 2nd day post-operative
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