Anterior Cruciate Ligament RuptureNCT06608394
Effect of Preoperative Exercise Habits on Knee Function and Recurrence Rate After Anterior Cruciate Ligament Reconstruction
An observational study of Anterior Cruciate Ligament Rupture, run by Peking University Third Hospital at 1 site in China.
Trial summary
The aim of this study is to compare the knee function between patients with and without preoperative exercise habits at 1, 2 and 5 years after ACL surgery, and further analyze the effect of maintaining exercise habits on knee function and recurrence rate Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Anterior Cruciate Ligament Rupture
- How many people
- 361 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2024to 31 Dec 2025
- 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: An ACL injury was diagnosed and an ACL reconstruction surgery was planned
Who may be able to join
- Patients with anterior cruciate ligament rupture in Department of Sports Medicine, Peking University Third Hospital
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking university third hospital
Beijing, Beijing Municipality, 100191
10822670720
About this study
The aim of this study is to compare the knee function between patients with and without preoperative exercise habits at 1, 2 and 5 years after ACL surgery, and further analyze the effect of maintaining exercise habits on knee function and recurrence rate
Read the 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.
- Conditions
- Anterior Cruciate Ligament Rupture
- Being tested
- no intervention
- Keywords
- anterior cruciate ligament injuries, exercise habit
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| Preoperative exercise habits group | Moderate-intensity aerobic exercise or strength training was performed at least 3 times per week for 6 months before surgery. Receives: Other: no intervention | |
| No exercise habit before operation group | There was no regular exercise habit for 6 months before surgery Receives: Other: no intervention | |
| The exercise habit group was maintained after operation | Moderate-intensity aerobic exercise was continued at least three times per week after surgery Receives: Other: no intervention | |
| The exercise habit was not maintained after operation | Did not maintain a regular exercise habit after surgery Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lysholm knee score
Measured: 1year，2year，5year
IKDC score
Measured: 1year，2year，5year
Tegner score
Measured: 1year，2year，5year
Beighton Score
Measured: 1year，2year，5year
Secondary outcomes (1)
recurrence rate
Measured: 1year，2year，5year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start30 Nov 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament RuptureStudies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 361 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06608394
- Sponsor's protocol ID
- M2024765
- Status last verified
- Sep 2024
- First submitted
- 19 Sep 2024
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Exercise Habits on Knee Function and Recurrence Rate After Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT06608394
- Acronym / sponsor ID
- M2024765
- Conditions
- Anterior Cruciate Ligament Rupture
- Keywords
- anterior cruciate ligament injuries, exercise habit
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 361 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 30 Nov 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 Sep 2024 (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.
The aim of this study is to compare the knee function between patients with and without preoperative exercise habits at 1, 2 and 5 years after ACL surgery, and further analyze the effect of maintaining exercise habits on knee function and recurrence rate
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Preoperative exercise habits group | – | Other: no interventionModerate-intensity aerobic exercise or strength training was performed at least 3 times per week for 6 months before surgery. |
| No exercise habit before operation group | – | Other: no interventionThere was no regular exercise habit for 6 months before surgery |
| The exercise habit group was maintained after operation | – | Other: no interventionModerate-intensity aerobic exercise was continued at least three times per week after surgery |
| The exercise habit was not maintained after operation | – | Other: no interventionDid not maintain a regular exercise habit after surgery |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- An ACL injury was diagnosed and an ACL reconstruction surgery was planned
Key inclusion criteria (1 listed)
- Patients with anterior cruciate ligament rupture in Department of Sports Medicine, Peking University Third Hospital
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| no interventionno intervention | Other | No exercise habit before operation group, Preoperative exercise habits group, The exercise habit group was maintained after operation, The exercise habit was not maintained after operation |
Primary outcome
Lysholm knee score
Time frame: 1year，2year，5year
IKDC score
Time frame: 1year，2year，5year
Tegner score
Time frame: 1year，2year，5year
Beighton Score
Time frame: 1year，2year，5year
1 secondary outcome
recurrence rate
Time frame: 1year，2year，5year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Individual participant dataSharing planned: No
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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.
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 Anterior Cruciate Ligament Rupture, 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 3 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 12 Feb 2025. 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 Ruiqin dang (19261022008, dangruiqin0919@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lysholm knee score (time frame: 1year，2year，5year). The study lists 4 primary outcomes in all. 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 12 Feb 2025.