Functional Exercise TrainingNCT06894706
The Impact of Functional Exercise Training on Postoperative Knee Joint Recovery in Patients with Meniscal Injury
A study testing Functional exercise training (FET) group in people with Functional Exercise Training and Knee Meniscus Injury, run by Biao Yang at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Functional Exercise Training, Knee Meniscus Injury, Knee Joint Function
- What is being tested?
- Functional exercise training (FET) group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 1 Dec 2024
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- meniscus injury was diagnosed by magnetic resonance imaging; meniscoplasty was performed; No shedding occurred during follow-up.
Who cannot join
- Patients with joint dislocation and fracture; poor compliance; severe osteoarthritis, rheumatoid arthritis; Combined with metabolic diseases, coagulation disorders and serious organic diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Control （CON） group, Functional exercise training (FET) group
- Keywords
- Functional exercise training, knee meniscus injury, knee joint function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control （CON） groupBehavioural
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.
Functional exercise training (FET) groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Functional exercise training (FET) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic data comparison
Measured: baseline, pre-intervention
Secondary outcomes (9)
Lysholm Knee Scoring Scale scores
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.
Measured: up to 24 weeks
International Society of Knee Injuries and Arthroscopy Score
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.
Measured: up to 24 weeks
Range of Motion
Measured: up to 24 weeks
Visual Analog Scale
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.
Measured: up to 24 weeks
Passive position sense
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.
Measured: up to 24 weeks
Kinesthesia test
Measured: up to 24 weeks
Prostaglandin E2
Measured: up to 24 weeks
5-hydroxytryptamine
Measured: up to 24 weeks
complications
The incidence of complications in the first month after operation was measured
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start1 Apr 2023
- Primary completion1 Sep 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Exercise TrainingStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biao Yang
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Biao Yang, Lanzhou Anning District People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06894706
- Sponsor's protocol ID
- No. 20240927
- Status last verified
- Sep 2024
- First submitted
- 10 Mar 2025
- Last updated
- 25 Mar 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 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lanzhou Anning District People's Hospital
- ClinicalTrials.gov ID
- NCT06894706
- Acronym / sponsor ID
- No. 20240927
- Keywords
- Functional exercise training, knee meniscus injury, knee joint function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Biao YangOther government
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 25 Mar 2025 (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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control （CON） group | Other | Behavioral: Control （CON） groupBoth 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. |
| Functional exercise training (FET) group | Other | Behavioral: Functional exercise training (FET) groupPatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- meniscus injury was diagnosed by magnetic resonance imaging; meniscoplasty was performed; No shedding occurred during follow-up.
Key exclusion criteria (1 listed)
- Patients with joint dislocation and fracture; poor compliance; severe osteoarthritis, rheumatoid arthritis; Combined with metabolic diseases, coagulation disorders and serious organic diseases.
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 |
|---|---|---|
| Control （CON） groupBoth 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. | Behavioural | Control （CON） group |
| Functional exercise training (FET) groupPatients 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. | Behavioural | Functional exercise training (FET) group |
Primary outcome
Demographic data comparison
Time frame: baseline, pre-intervention
9 secondary outcomes
Lysholm Knee Scoring Scale scores
Time frame: up to 24 weeks
International Society of Knee Injuries and Arthroscopy Score
Time frame: up to 24 weeks
Range of Motion
Time frame: up to 24 weeks
Visual Analog Scale
Time frame: up to 24 weeks
Passive position sense
Time frame: up to 24 weeks
Kinesthesia test
Time frame: up to 24 weeks
Prostaglandin E2
Time frame: up to 24 weeks
5-hydroxytryptamine
Time frame: up to 24 weeks
complications
Time frame: up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional exercise training (FET) group in people with Functional Exercise Training and Knee Meniscus Injury, run by Biao Yang 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 1 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: finished, as of the sponsor's last update on 25 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic data comparison (time frame: baseline, pre-intervention). 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 25 Mar 2025.