- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04963361
Study on Fear of Movement After Total Knee Arthroplasty
A Survey of Fear of Exercise and Its Influencing Factors in Patients After Total Knee Arthroplasty
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Tao Li
- Phone Number: 13811397872
- Email: tobetheone@126.com
Study Locations
-
-
-
Beijing, China
- Recruiting
- Peking University Third Hospital
-
Contact:
- Taobao Li
- Phone Number: 13811397872
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
fear of movement group
The score of fear of movement scale was more than 37
|
Patients completed the questionnaires independently
|
non-fear of movement group
The score of fear of movement scale was no more than 37
|
Patients completed the questionnaires independently
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The occurrence of fear of movement
Time Frame: 2nd day post-operative
|
Score of Tampa for kinesiophobia(TSK) ranging from17-68.The higher score means the worse outcome
|
2nd day post-operative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospital Ansiety and Depression Scale(HADS)
Time Frame: 2nd day post-operative
|
The score of HADS ranging from 0-48,the higher score means the worse outcome
|
2nd day post-operative
|
General Self Efficacy Scale(GSES)
Time Frame: 2nd day post-operative
|
The score of GSES,ranging from 1-40,the higher socre means the better outcome
|
2nd day post-operative
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tao Li, Peking University Third Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- M2021182
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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