NCT04963361

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
121

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 25, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 15, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2021

Completed
Last Updated

July 15, 2021

Status Verified

June 1, 2021

Enrollment Period

6 months

First QC Date

June 27, 2021

Last Update Submit

July 8, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 (2)

  • Hospital Ansiety and Depression Scale(HADS)

    2nd day post-operative

  • General Self Efficacy Scale(GSES)

    2nd day post-operative

Study Arms (2)

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

Patients completed the questionnaires independently

fear of movement group

Patients completed the questionnaires independently

non-fear of movement group

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients after total knee arthroplasty

You may qualify if:

  • (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.

You may not qualify if:

  • (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, China

RECRUITING

Study Officials

  • Tao Li

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2021

First Posted

July 15, 2021

Study Start

March 25, 2021

Primary Completion

September 25, 2021

Study Completion

September 25, 2021

Last Updated

July 15, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations