- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06608394
Effect of Preoperative Exercise Habits on Knee Function and Recurrence Rate After Anterior Cruciate Ligament Reconstruction
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Objective:
- To compare the knee function between active and inactive patients at 1, 2, and 5 years after ACL surgery.
- To investigate the difference of knee function and recurrence rate between patients with and without postoperative exercise habit.
Methods: This is a single-center, controlled follow-up cohort study. Inclusion criteria included patients aged 18-45 years with confirmed ACL injury who were scheduled to undergo ACL reconstruction surgery. Exercise habits were recorded before operation, and knee joint function and exercise level were evaluated by questionnaires. All patients received standardized ACL reconstruction surgery and rehabilitation program after surgery. In prospective cohort study, 121 patients were divided into running group and non-running group according to their preoperative exercise habits. At 3 months after surgery, running was included in the rehabilitation program, and the patients were further divided into postoperative running and non-running groups and followed up for one year.In Postoperative cohort study, follow-up was collected and evaluated at 1 year, 2 years and 5 years, including knee function, exercise level and recurrence. The study was divided into four groups: preoperative running group , preoperative non-running group , preoperative and postoperative running group and preoperative non-running and postoperative running group to analyze the effects of preoperative and postoperative exercise habits on knee joint function and recurrence rate. The results of this study will help to deepen the understanding of the impact of preoperative exercise habits and postoperative exercise maintenance on knee function and recurrence rate after ACL reconstruction, and then provide guidance for clinical practice, optimize postoperative rehabilitation programs, and ultimately improve the quality of life of patients.
Subjects: Patients with anterior cruciate ligament rupture in Department of Sports Medicine, Peking University Third Hospital 1.1.1 Inclusion criteria
- Age of 18-45 years old, male or female.
Patients were diagnosed with anterior cruciate ligament injury and planned to undergo anterior cruciate ligament reconstruction surgery 1.1.2 Exclusion criteria Presence of other severe knee disorders (e.g., arthritis).
- Prior history of other knee surgeries
- Inability to complete a postoperative rehabilitation program or long-term follow-up.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ruiqin dang
- Phone Number: 19261022008
- Email: dangruiqin0919@163.com
Study Contact Backup
- Name: Jianquan wang
- Phone Number: 13801076267
- Email: wjqsportsmed@163.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100191
- Recruiting
- Peking University Third Hospital
-
Contact:
- Phone Number: 10822670720
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with anterior cruciate ligament rupture in Department of Sports Medicine, Peking University Third Hospital
Exclusion Criteria:
- Severe other knee disorders (e.g., arthritis) are present.
- Prior history of other knee surgeries
- Inability to complete a postoperative rehabilitation program or long-term follow-up
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Preoperative exercise habits group
Moderate-intensity aerobic exercise or strength training was performed at least 3 times per week for 6 months before surgery.
|
no intervention
|
|
No exercise habit before operation group
There was no regular exercise habit for 6 months before surgery
|
no intervention
|
|
The exercise habit group was maintained after operation
Moderate-intensity aerobic exercise was continued at least three times per week after surgery
|
no intervention
|
|
The exercise habit was not maintained after operation
Did not maintain a regular exercise habit after surgery
|
no intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Lysholm knee score
Time Frame: 1year,2year,5year
|
1year,2year,5year
|
|
IKDC score
Time Frame: 1year,2year,5year
|
1year,2year,5year
|
|
Tegner score
Time Frame: 1year,2year,5year
|
1year,2year,5year
|
|
Beighton Score
Time Frame: 1year,2year,5year
|
1year,2year,5year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
recurrence rate
Time Frame: 1year,2year,5year
|
1year,2year,5year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- M2024765
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
product manufactured in and exported from the U.S.
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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