Total Knee ArthroplastyNCT04963361
Study on Fear of Movement After Total Knee Arthroplasty
An observational study of Total Knee Arthroplasty, run by Peking University Third Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- patients were exposed to fear of movement and patients were not exposed to fear of movement
- How many people
- 121 participants
- Where
- 1 siteChina
- Study dates
- 25 Mar 2021to 25 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients after total knee arthroplasty
Who may be able to join
- （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.
Who cannot join
- （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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing
Taobao Li, 13811397872
About this study
Official title: A Survey of Fear of Exercise and Its Influencing Factors in Patients After Total Knee Arthroplasty
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
Read the 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.
- Conditions
- Total Knee Arthroplasty
- Being tested
- patients were exposed to fear of movement, patients were not exposed to fear of movement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patients were exposed to fear of movementOther
Patients completed the questionnaires independently
patients were not exposed to fear of movementOther
Patients completed the questionnaires independently
| Study group | Role | What they receive |
|---|---|---|
| fear of movement group | The score of fear of movement scale was more than 37 Receives: 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 Receives: Other: patients were not exposed to fear of movement |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of fear of movement
Score of Tampa for kinesiophobia(TSK) ranging from17-68.The higher score means the worse outcome
Measured: 2nd day post-operative
Secondary outcomes (2)
Hospital Ansiety and Depression Scale(HADS)
The score of HADS ranging from 0-48,the higher score means the worse outcome
Measured: 2nd day post-operative
General Self Efficacy Scale(GSES)
The score of GSES,ranging from 1-40,the higher socre means the better outcome
Measured: 2nd day post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start25 Mar 2021
- Primary completion25 Sep 2021 (estimated)
- Study completion25 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 121 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tao Li, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04963361
- Sponsor's protocol ID
- M2021182
- Status last verified
- Jun 2021
- First submitted
- 27 Jun 2021
- Last updated
- 15 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Survey of Fear of Exercise and Its Influencing Factors in Patients After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT04963361
- Acronym / sponsor ID
- M2021182
- Conditions
- Total Knee Arthroplasty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 121 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 25 Sep 2021 (estimated)
- Study completion
- 25 Sep 2021 (estimated)
- First posted
- 15 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fear of movement group | – | Other: patients were exposed to fear of movementThe score of fear of movement scale was more than 37 |
| non-fear of movement group | – | Other: patients were not exposed to fear of movementThe score of fear of movement scale was no more than 37 |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients after total knee arthroplasty
Key inclusion criteria (1 listed)
- （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.
Key exclusion criteria (1 listed)
- （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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patients were exposed to fear of movementPatients completed the questionnaires independently | Other | fear of movement group |
| patients were not exposed to fear of movementPatients completed the questionnaires independently | Other | non-fear of movement group |
Primary outcome
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
2 secondary outcomes
Hospital Ansiety and Depression Scale(HADS)
Time frame: 2nd day post-operative
General Self Efficacy Scale(GSES)
Time frame: 2nd day post-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
- Individual participant dataSharing planned: No
Related trials for Total Knee Arthroplasty
RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
Recruiting
SII Levels Following iPACK Block With Adductor Canal Block in Knee Arthroplasty
Knee Osteoarthritis
Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
Rhematoid Arthritis, Osteo Arthritis of the Knee
Recruiting
ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
Knee Osteoarthritis
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tao Li principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Knee Arthroplasty, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tao Li (13811397872, tobetheone@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence of fear of movement (time frame: 2nd day post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2021.