NCT06894706

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 25, 2025

Completed
Last Updated

March 25, 2025

Status Verified

September 1, 2024

Enrollment Period

1.4 years

First QC Date

March 10, 2025

Last Update Submit

March 19, 2025

Conditions

Keywords

Functional exercise trainingknee meniscus injuryknee joint function

Outcome Measures

Primary Outcomes (1)

  • Demographic data comparison

    baseline, pre-intervention

Secondary Outcomes (9)

  • Lysholm Knee Scoring Scale scores

    up to 24 weeks

  • International Society of Knee Injuries and Arthroscopy Score

    up to 24 weeks

  • Range of Motion

    up to 24 weeks

  • Visual Analog Scale

    up to 24 weeks

  • Passive position sense

    up to 24 weeks

  • +4 more secondary outcomes

Study Arms (2)

Control (CON) group

OTHER

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.

Behavioral: Control (CON) group

Functional exercise training (FET) group

OTHER

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.

Behavioral: Functional exercise training (FET) group

Interventions

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.

Control (CON) 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.

Functional exercise training (FET) group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lanzhou Anning District People's Hospital

Lanzhou, China

Location

MeSH Terms

Interventions

Population Groups

Intervention Hierarchy (Ancestors)

DemographyPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lanzhou Anning District People's Hospital

Study Record Dates

First Submitted

March 10, 2025

First Posted

March 25, 2025

Study Start

April 1, 2023

Primary Completion

September 1, 2024

Study Completion

December 1, 2024

Last Updated

March 25, 2025

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations