- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06870656
Muscle Isometric Contraction for the Treatment of Knee Osteoarthritis (KOA)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Shuwan Chang
- Phone Number: 18280314728
- Email: changshuwan1025@163.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Cardiovascular diseases;
- Need for surgery or pharmacological treatment in the near future;
- Neuromuscular diseases;
- Currently engaged in regular exercise.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Low-intensity group
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.
|
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.
Other Names:
|
|
Experimental: Medium-intensity group
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.
|
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.
|
|
Experimental: High-intensity group
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.
|
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.
|
|
No Intervention: Control group
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
16 weeks
|
|
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.
|
16 weeks
|
|
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.
|
16 weeks
|
|
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.
|
16 weeks
|
|
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.
|
16 weeks
|
|
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.
|
16 weeks
|
|
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.
|
16 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Liang Cheng, Chengdu Sport University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Muscle isometric contraction
- 2024ZYD0001 (Other Grant/Funding Number: This work was supported by the Central Guidance for Local Science and Technology Development Fund Projects)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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