The Impact of Functional Exercise Training on Postoperative Knee Joint Recovery in Patients with Meniscal Injury

March 19, 2025 updated by: Biao Yang

Lanzhou Anning District People's Hospital

AIM: To investigate the impact of functional exercise training on postoperative functional recovery in patients with knee meniscus injuries.

METHODS:A prospective randomized controlled trial (RCT) was conducted from April 2023 to September 2024, involving 96 patients with knee meniscus injuries who underwent meniscus repair interventions. Participants were randomly assigned to either the Control (CON) group (n=48) or the functional exercise training (FET) group (n=48) using a computer-generated random number table. The CON group received standard rehabilitation, while the FET group underwent functional exercise training. Clinical outcomes were evaluated at baseline, 1 month, and 6 months post-intervention, including the Lysholm score, IKDC score, VAS pain score, range of motion (ROM), serum levels of prostaglandin E2 (PGE2) and serotonin (5-HT), as well as passive 60° position sense and 60° motion sense. Postoperative complications occurring within 1 month were also recorded.

Study Overview

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Lanzhou, China
        • Lanzhou Anning District People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • meniscus injury was diagnosed by magnetic resonance imaging; meniscoplasty was performed; No shedding occurred during follow-up.

Exclusion Criteria:

  • Patients with joint dislocation and fracture; poor compliance; severe osteoarthritis, rheumatoid arthritis; Combined with metabolic diseases, coagulation disorders and serious organic diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control (CON) group
Both groups were given arthroscopy and meniscoplasty. After operation, the control group received active knee flexion and extension exercise, ankle pump training, quadriceps muscle training and other routine rehabilitation training.
Both groups were given arthroscopy and meniscoplasty. After operation, the control group received active knee flexion and extension exercise, ankle pump training, quadriceps muscle training and other routine rehabilitation training.
Other: Functional exercise training (FET) group
Patients in the observation group were supplemented with neuromuscular training on the basis of routine rehabilitation training, and received rehabilitation education before training. The patients were informed of the specific content, frequency, expected effect and importance of training in various forms such as on-site demonstration combined with publicity brochures and playing videos, so as to improve patient cooperation.
Patients in the observation group were supplemented with neuromuscular training on the basis of routine rehabilitation training, and received rehabilitation education before training. The patients were informed of the specific content, frequency, expected effect and importance of training in various forms such as on-site demonstration combined with publicity brochures and playing videos, so as to improve patient cooperation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Demographic data comparison
Time Frame: baseline, pre-intervention
baseline, pre-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lysholm Knee Scoring Scale scores
Time Frame: up to 24 weeks
The Lysholm Knee Scale (Lysholm Knee Scale) is a widely used assessment tool to measure the functional status and quality of life of the knee joint, especially in the assessment of recovery after knee injury and surgery. The scale quantifies knee function through eight items (such as claudication, pain, stability, etc.), with a total score ranging from 0 to 100, with higher scores indicating better knee function. The Lysholm Scale is designed to provide clinicians with an effective assessment tool to help them judge the impact of knee disease and injury. The MCID is 10 points.
up to 24 weeks
International Society of Knee Injuries and Arthroscopy Score
Time Frame: up to 24 weeks
IKDC (International Knee Injury and Arthroscopy Score) is a tool used to assess knee function and symptoms and is widely used in rehabilitation assessment of knee injuries, especially in recovery monitoring after anterior cruciate ligament and meniscus injuries. The rating scale includes four main items: symptoms (pain, swelling, etc.), activity (functional limitations in daily activities), motor capacity (performance in physical activities), and function (knee stability and load-bearing capacity). The IKDC score is scored on a scale of 0 to 100, with 0 indicating complete loss of knee function and 100 indicating complete recovery and normal function of the knee. The higher the score, the better, indicating better knee function and less severe symptoms. The MCID (minimum clinically significant difference) of IKDC is usually 10 points.
up to 24 weeks
Range of Motion
Time Frame: up to 24 weeks
up to 24 weeks
Visual Analog Scale
Time Frame: up to 24 weeks
Visual analog scale (VAS) is a commonly used subjective pain assessment tool, which is widely used in clinical practice and research. It is usually scored on a scale of 0 to 10, which is explained as follows: 0: completely painless. 1 to 3 points: mild pain, does not affect daily life. Scores 4 to 6: Moderate pain that interferes with daily activities and sleep. Score 7 to 10: Severe pain that severely affects quality of life and daily functioning. MCID is usually 2 points.
up to 24 weeks
Passive position sense
Time Frame: up to 24 weeks
The sensory threshold measurement method was used to measure passive position perception, motion perception and isotonic power. During the passive 60° position perception test, subjects were asked to sit and stop when they felt reaching the target Angle with an eye mask and headset. Each Angle was repeated three times. Record the error between the target Angle and the measured Angle; 10% of the maximum contraction force of the quadriceps isometric resistance was selected, and the activity Angle of the knee joint was set as the activity degree of the knee joint in the seated position. 60 was measured on a CPM machine using a motion test sensor. The subjects passively completed 60° knee flexion and extension at a constant angular speed of 1° / s. The subjects stopped the movement when they felt the joint movement or the joint position change. Three tests were conducted and the Angle of each perceived movement was recorded.
up to 24 weeks
Kinesthesia test
Time Frame: up to 24 weeks
up to 24 weeks
Prostaglandin E2
Time Frame: up to 24 weeks
up to 24 weeks
5-hydroxytryptamine
Time Frame: up to 24 weeks
up to 24 weeks
complications
Time Frame: up to 24 weeks
The incidence of complications in the first month after operation was measured
up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Actual)

September 1, 2024

Study Completion (Actual)

December 1, 2024

Study Registration Dates

First Submitted

March 10, 2025

First Submitted That Met QC Criteria

March 19, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 19, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • No. 20240927

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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