Study on Fear of Movement After Total Knee Arthroplasty | NCT04963361

Studies
Study on Fear of Movement After Total Knee Arthroplasty

NCT04963361

Sponsor

Peking University Third Hospital

Status

Unknown status

Last Update Posted

Jul 15, 2021Actual

Enrollment

121Estimated

Phase

Not provided

Conditions

Total Knee Arthroplasty

Interventions

patients were exposed to fear of movement
patients were not exposed to fear of movement

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 25, 2021Actual

Primary Completion Date

Sep 25, 2021Estimated

Completion Date

Sep 25, 2021Estimated

First Submitted Date

Jun 27, 2021

First Submission Date that Met QC Criteria

Jul 8, 2021

First Posted Date

Jul 15, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 8, 2021

Last Update Posted Date

Jul 15, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

121Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
fear of movement group		The score of fear of movement scale was more than 37	Other: patients were exposed to fear of movement
non-fear of movement group		The score of fear of movement scale was no more than 37	Other: patients were not exposed to fear of movement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
patients were exposed to fear of movement	Other	Patients completed the questionnaires independently	fear of movement group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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
General Self Efficacy Scale(GSES)	The score of GSES,ranging from 1-40,the higher socre means the better outcome

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients after total knee arthroplasty

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tao Li	Contact	13811397872		tobetheone@126.com

Overall Officials

Name	Affiliation	Role
Tao Li	Peking University Third Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University Third Hospital	Recruiting	Beijing			China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided