Knee Osteoarthritis (Knee OA)KOANCT06870656
Muscle Isometric Contraction for the Treatment of Knee Osteoarthritis
A study testing Low-intensity group, Medium-intensity group and High-intensity group in people with Knee Osteoarthritis (Knee OA), run by Chengdu Sport University.
Trial summary
This study compares the effects of three different intensities of Muscle Isometric Contraction (MIC) on balance ability, proprioception, muscle strength, KOA symptoms, and inflammatory factors in synovial fluid among elderly individuals with Knee Osteoarthritis (KOA). Read more about this study
- Who is it for?
- Ages 60 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis (Knee OA)
- What is being tested?
- Low-intensity group, Medium-intensity group and High-intensity group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2025to 20 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women aged 60 to 80 years;
- Based on the diagnostic criteria for knee osteoarthritis (KOA) established by the American College of Rheumatology in 2001, participants with KOA graded 1 to 3 were selected;
- Compliance with the Declaration of Helsinki and signing of the informed consent form.
Who cannot join
- Cardiovascular diseases;
- Need for surgery or pharmacological treatment in the near future;
- Neuromuscular diseases;
- Currently engaged in regular exercise.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study compares the effects of three different intensities of Muscle Isometric Contraction (MIC) on balance ability, proprioception, muscle strength, KOA symptoms, and inflammatory factors in synovial fluid among elderly individuals with Knee Osteoarthritis (KOA).
Read the detailed description
A total of 120 elderly individuals with Knee Osteoarthritis (KOA) will be recruited and randomly assigned into four groups using a digital randomization method: low-intensity group (n = 30), medium-intensity group (n = 30), high-intensity group (n = 30), and control group (n = 30). The elderly individuals in the low-, medium-, and high-intensity groups will receive five interventions per week targeting the quadriceps femoris muscle. For each intervention, the quadriceps will perform an isometric contraction and relaxation for 1 second each. The low-, medium-, and high-intensity groups will perform 10, 20, and 30 repetitions per set, respectively, of Muscle Isometric Contraction (MIC) (guided by a rhythmic timer), completing a total of 10 sets with a 30-second rest between sets. The entire intervention will last for 16 weeks. Researchers will follow up with participants weekly to complete exercise record forms, ensuring that all subjects maintain their original lifestyle and dietary habits. The study aims to compare the effects of three different intensities of MIC on balance ability, proprioception, muscle strength, KOA symptoms, and inflammatory factors in synovial fluid among elderly individuals with KOA.
- Conditions
- Knee Osteoarthritis (Knee OA)
- Being tested
- Low-intensity group, Medium-intensity group, High-intensity group
- Keywords
- KOA, Muscle isometric contraction
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-intensity groupOther
Also called Muscle Isometric Contraction
Firstly, they received the same health education as the control group. Subsequently, the elderly individuals with Knee Osteoarthritis (KOA) underwent five interventions per week targeting the quadriceps femoris muscle. For each intervention, the quadriceps performed an isometric contraction and relaxation for 1 second each. The intervention consisted of 10 repetitions per set of Muscle Isometric Contraction (MIC), guided by a rhythmic timer, for a total of 10 sets, with a 30-second rest between sets. The entire intervention lasted for 16 weeks.
Medium-intensity groupOther
Firstly, they received the same health education as the control group. Subsequently, the elderly individuals with Knee Osteoarthritis (KOA) underwent five interventions per week targeting the quadriceps femoris muscle. For each intervention, the quadriceps performed an isometric contraction and relaxation for 1 second each. The intervention consisted of 20 repetitions per set of Muscle Isometric Contraction (MIC), guided by a rhythmic timer, for a total of 10 sets, with a 30-second rest between sets. The entire intervention lasted for 16 weeks.
High-intensity groupOther
Firstly, they received the same health education as the control group. Subsequently, the elderly individuals with Knee Osteoarthritis (KOA) underwent five interventions per week targeting the quadriceps femoris muscle. For each intervention, the quadriceps performed an isometric contraction and relaxation for 1 second each. The intervention consisted of 30 repetitions per set of Muscle Isometric Contraction (MIC), guided by a rhythmic timer, for a total of 10 sets, with a 30-second rest between sets. The entire intervention lasted for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Low-intensity group | Experimental | Firstly, they received the same health education as the control group. Subsequently, the elderly individuals with Knee Osteoarthritis (KOA) underwent five interventions per week targeting the quadriceps femoris muscle. For each intervention, the quadriceps performed an isometric contraction and relaxation for 1 second each. The intervention consisted of 10 repetitions per set of Muscle Isometric Contraction (MIC), guided by a rhythmic timer, for a total of 10 sets, with a 30-second rest between sets. The entire intervention lasted for 16 weeks. Receives: Other: Low-intensity group |
| Medium-intensity group | Experimental | Firstly, they received the same health education as the control group. Subsequently, the elderly individuals with Knee Osteoarthritis (KOA) underwent five interventions per week targeting the quadriceps femoris muscle. For each intervention, the quadriceps performed an isometric contraction and relaxation for 1 second each. The intervention consisted of 20 repetitions per set of Muscle Isometric Contraction (MIC), guided by a rhythmic timer, for a total of 10 sets, with a 30-second rest between sets. The entire intervention lasted for 16 weeks. Receives: Other: Medium-intensity group |
| High-intensity group | Experimental | Firstly, they received the same health education as the control group. Subsequently, the elderly individuals with Knee Osteoarthritis (KOA) underwent five interventions per week targeting the quadriceps femoris muscle. For each intervention, the quadriceps performed an isometric contraction and relaxation for 1 second each. The intervention consisted of 30 repetitions per set of Muscle Isometric Contraction (MIC), guided by a rhythmic timer, for a total of 10 sets, with a 30-second rest between sets. The entire intervention lasted for 16 weeks. Receives: Other: High-intensity group |
| Control group | No intervention | Health Education: All participants received standardized health guidance, which was delivered in the form of a weekly 60-minute lecture. The content of the lectures included the following: Emphasizing the importance of close cooperation with medical professionals for maintaining health. Explaining the etiology, progression, and treatment options for Knee Osteoarthritis (KOA). Discussing the positive impact of family and social support on recovery. Providing guidance on establishing healthy daily living habits, such as protecting the affected knee joints, avoiding prolonged walking, climbing, or frequent use of stairs, and correcting poor postures (e.g., prolonged standing, kneeling, and squatting). For those who are overweight, weight loss was recommended. |
What is being measured
The primary outcome is the main question the study is designed to answer.
KOA Symptoms
The symptoms of patients with Knee Osteoarthritis (KOA) were assessed using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) scale. This scale comprises three dimensions: pain (5 items), stiffness (2 items), and functional limitation (17 items), totaling 24 items. Participants were required to mark their responses on a visual analog scale ranging from 0 to 100 millimeters, which were then measured and recorded by professionals using a ruler. The maximum scores for pain, stiffness, and functional limitation are 500, 200, and 1700 points, respectively. Higher scores indicate greater severity of symptoms. For the Chinese KOA patient population, the scale has demonstrated high internal consistency (Cronbach's α > 0.7) and good reliability (ICC > 0.8) (Xie et al., Quality of Life Research, 2008).
Measured: 16 weeks
Balance Ability
The BioDex Balance System from the United States was used to test the participants' balance ability, with three tests conducted and the average value taken.
Measured: 16 weeks
Muscle Strength
The IsoMed 2000 isokinetic dynamometer from Germany was used to test the isokinetic muscle strength of the participants' bilateral knee joints.
Measured: 16 weeks
Proprioception
The BioDex isokinetic dynamometer from the United States was used to test the proprioception of the participants' dominant knee joint.
Measured: 16 weeks
Expression of IL-1β in Knee Synovial Fluid
Synovial fluid was aspirated from one or both knee joints of the participants, with a total volume of 1 mL collected. The expression of IL-1β mRNA was measured using RT-qPCR.
Measured: 16 weeks
Expression of TNF-α in Knee Synovial Fluid
Synovial fluid was aspirated from one or both knee joints of the participants, with a total volume of 1 mL collected. The expression of TNF-α mRNA was measured using RT-qPCR.
Measured: 16 weeks
Expression of MMP-13 in Knee Synovial Fluid
Synovial fluid was aspirated from one or both knee joints of the participants, with a total volume of 1 mL collected. The expression of MMP-13 mRNA was measured using RT-qPCR.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start20 Sep 2025 (estimated)
- Primary completion20 Sep 2025 (estimated)
- Study completion20 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Osteoarthritis (Knee OA)Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu Sport University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheng Liang, Chengdu Sport University
- Investigators
- Liang Cheng, Principal investigator, Chengdu Sport University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870656
- Sponsor's protocol ID
- Muscle isometric contraction
- Other IDs
- 2024ZYD0001
- Acronym
- KOA
- Status last verified
- Mar 2025
- First submitted
- 6 Mar 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Isometric Contraction for the Treatment of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06870656
- Acronym / sponsor ID
- KOA / Muscle isometric contraction
- Conditions
- Knee Osteoarthritis (Knee OA)
- Keywords
- KOA, Muscle isometric contraction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chengdu Sport UniversityUniversity, hospital or other
- Study start
- 20 Sep 2025 (estimated)
- Primary completion
- 20 Sep 2025 (estimated)
- Study completion
- 20 Sep 2025 (estimated)
- First posted
- 11 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.
This study compares the effects of three different intensities of Muscle Isometric Contraction (MIC) on balance ability, proprioception, muscle strength, KOA symptoms, and inflammatory factors in synovial fluid among elderly individuals with Knee Osteoarthritis (KOA).
Detailed description
A total of 120 elderly individuals with Knee Osteoarthritis (KOA) will be recruited and randomly assigned into four groups using a digital randomization method: low-intensity group (n = 30), medium-intensity group (n = 30), high-intensity group (n = 30), and control group (n = 30). The elderly individuals in the low-, medium-, and high-intensity groups will receive five interventions per week targeting the quadriceps femoris muscle. For each intervention, the quadriceps will perform an isometric contraction and relaxation for 1 second each. The low-, medium-, and high-intensity groups will perform 10, 20, and 30 repetitions per set, respectively, of Muscle Isometric Contraction (MIC) (guided by a rhythmic timer), completing a total of 10 sets with a 30-second rest between sets. The entire intervention will last for 16 weeks. Researchers will follow up with participants weekly to complete exercise record forms, ensuring that all subjects maintain their original lifestyle and dietary habits. The study aims to compare the effects of three different intensities of MIC on balance ability, proprioception, muscle strength, KOA symptoms, and inflammatory factors in synovial fluid among elderly individuals with KOA.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low-intensity group | Experimental | Other: Low-intensity groupFirstly, they received the same health education as the control group. Subsequently, the elderly individuals with Knee Osteoarthritis (KOA) underwent five interventions per week targeting the quadriceps femoris muscle. For each intervention, the quadriceps performed an isometric contraction and relaxation for 1 second each. The intervention consisted of 10 repetitions per set of Muscle Isometric Contraction (MIC), guided by a rhythmic timer, for a total of 10 sets, with a 30-second rest between sets. The entire intervention lasted for 16 weeks. |
| Medium-intensity group | Experimental | Other: Medium-intensity groupFirstly, they received the same health education as the control group. Subsequently, the elderly individuals with Knee Osteoarthritis (KOA) underwent five interventions per week targeting the quadriceps femoris muscle. For each intervention, the quadriceps performed an isometric contraction and relaxation for 1 second each. The intervention consisted of 20 repetitions per set of Muscle Isometric Contraction (MIC), guided by a rhythmic timer, for a total of 10 sets, with a 30-second rest between sets. The entire intervention lasted for 16 weeks. |
| High-intensity group | Experimental | Other: High-intensity groupFirstly, they received the same health education as the control group. Subsequently, the elderly individuals with Knee Osteoarthritis (KOA) underwent five interventions per week targeting the quadriceps femoris muscle. For each intervention, the quadriceps performed an isometric contraction and relaxation for 1 second each. The intervention consisted of 30 repetitions per set of Muscle Isometric Contraction (MIC), guided by a rhythmic timer, for a total of 10 sets, with a 30-second rest between sets. The entire intervention lasted for 16 weeks. |
| Control group | No intervention | –Health Education: All participants received standardized health guidance, which was delivered in the form of a weekly 60-minute lecture. The content of the lectures included the following: Emphasizing the importance of close cooperation with medical professionals for maintaining health. Explaining the etiology, progression, and treatment options for Knee Osteoarthritis (KOA). Discussing the positive impact of family and social support on recovery. Providing guidance on establishing healthy daily living habits, such as protecting the affected knee joints, avoiding prolonged walking, climbing, or frequent use of stairs, and correcting poor postures (e.g., prolonged standing, kneeling, and squatting). For those who are overweight, weight loss was recommended. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women aged 60 to 80 years;
- Based on the diagnostic criteria for knee osteoarthritis (KOA) established by the American College of Rheumatology in 2001, participants with KOA graded 1 to 3 were selected;
- Compliance with the Declaration of Helsinki and signing of the informed consent form.
Key exclusion criteria (4 listed)
- Cardiovascular diseases;
- Need for surgery or pharmacological treatment in the near future;
- Neuromuscular diseases;
- Currently engaged in regular exercise.
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 |
|---|---|---|
| Low-intensity groupAlso: Muscle Isometric ContractionFirstly, they received the same health education as the control group. Subsequently, the elderly individuals with Knee Osteoarthritis (KOA) underwent five interventions per week targeting the quadriceps femoris muscle. For each intervention, the quadriceps performed an isometric contraction and relaxation for 1 second each. The intervention consisted of 10 repetitions per set of Muscle Isometric Contraction (MIC), guided by a rhythmic timer, for a total of 10 sets, with a 30-second rest between sets. The entire intervention lasted for 16 weeks. | Other | Low-intensity group |
| Medium-intensity groupFirstly, they received the same health education as the control group. Subsequently, the elderly individuals with Knee Osteoarthritis (KOA) underwent five interventions per week targeting the quadriceps femoris muscle. For each intervention, the quadriceps performed an isometric contraction and relaxation for 1 second each. The intervention consisted of 20 repetitions per set of Muscle Isometric Contraction (MIC), guided by a rhythmic timer, for a total of 10 sets, with a 30-second rest between sets. The entire intervention lasted for 16 weeks. | Other | Medium-intensity group |
| High-intensity groupFirstly, they received the same health education as the control group. Subsequently, the elderly individuals with Knee Osteoarthritis (KOA) underwent five interventions per week targeting the quadriceps femoris muscle. For each intervention, the quadriceps performed an isometric contraction and relaxation for 1 second each. The intervention consisted of 30 repetitions per set of Muscle Isometric Contraction (MIC), guided by a rhythmic timer, for a total of 10 sets, with a 30-second rest between sets. The entire intervention lasted for 16 weeks. | Other | High-intensity group |
Primary outcome
KOA Symptoms
Time frame: 16 weeks
The symptoms of patients with Knee Osteoarthritis (KOA) were assessed using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) scale. This scale comprises three dimensions: pain (5 items), stiffness (2 items), and functional limitation (17 items), totaling 24 items. Participants were required to mark their responses on a visual analog scale ranging from 0 to 100 millimeters, which were then measured and recorded by professionals using a ruler. The maximum scores for pain, stiffness, and functional limitation are 500, 200, and 1700 points, respectively. Higher scores indicate greater severity of symptoms. For the Chinese KOA patient population, the scale has demonstrated high internal consistency (Cronbach's α > 0.7) and good reliability (ICC > 0.8) (Xie et al., Quality of Life Research, 2008).
Balance Ability
Time frame: 16 weeks
The BioDex Balance System from the United States was used to test the participants' balance ability, with three tests conducted and the average value taken.
Muscle Strength
Time frame: 16 weeks
The IsoMed 2000 isokinetic dynamometer from Germany was used to test the isokinetic muscle strength of the participants' bilateral knee joints.
Proprioception
Time frame: 16 weeks
The BioDex isokinetic dynamometer from the United States was used to test the proprioception of the participants' dominant knee joint.
Expression of IL-1β in Knee Synovial Fluid
Time frame: 16 weeks
Synovial fluid was aspirated from one or both knee joints of the participants, with a total volume of 1 mL collected. The expression of IL-1β mRNA was measured using RT-qPCR.
Expression of TNF-α in Knee Synovial Fluid
Time frame: 16 weeks
Synovial fluid was aspirated from one or both knee joints of the participants, with a total volume of 1 mL collected. The expression of TNF-α mRNA was measured using RT-qPCR.
Expression of MMP-13 in Knee Synovial Fluid
Time frame: 16 weeks
Synovial fluid was aspirated from one or both knee joints of the participants, with a total volume of 1 mL collected. The expression of MMP-13 mRNA was measured using RT-qPCR.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis (Knee OA)
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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.
Liang Cheng principal investigator
Chengdu Sport University
Questions about this trial
What is this clinical trial studying?
A study testing Low-intensity group, Medium-intensity group and High-intensity group in people with Knee Osteoarthritis (Knee OA), run by Chengdu Sport University.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shuwan Chang (18280314728, changshuwan1025@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KOA Symptoms (time frame: 16 weeks). The study lists 7 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 11 Mar 2025.