NCT06608394

Brief 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

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
361

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 23, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

November 30, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 12, 2025

Status Verified

September 1, 2024

Enrollment Period

1.1 years

First QC Date

September 19, 2024

Last Update Submit

February 10, 2025

Conditions

Keywords

anterior cruciate ligament injuriesexercise habit

Outcome Measures

Primary Outcomes (4)

  • Lysholm knee score

    1year,2year,5year

  • IKDC score

    1year,2year,5year

  • Tegner score

    1year,2year,5year

  • Beighton Score

    1year,2year,5year

Secondary Outcomes (1)

  • recurrence rate

    1year,2year,5year

Study Arms (4)

Preoperative exercise habits group

Moderate-intensity aerobic exercise or strength training was performed at least 3 times per week for 6 months before surgery.

Other: no intervention

No exercise habit before operation group

There was no regular exercise habit for 6 months before surgery

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

Other: no intervention

The exercise habit was not maintained after operation

Did not maintain a regular exercise habit after surgery

Other: no intervention

Interventions

no intervention

No exercise habit before operation groupPreoperative exercise habits groupThe exercise habit group was maintained after operationThe exercise habit was not maintained after operation

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

An ACL injury was diagnosed and an ACL reconstruction surgery was planned

You may qualify if:

  • Patients with anterior cruciate ligament rupture in Department of Sports Medicine, Peking University Third Hospital

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking university third hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

September 19, 2024

First Posted

September 23, 2024

Study Start

November 30, 2024

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

February 12, 2025

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations