Muscle Isometric Contraction for the Treatment of Knee Osteoarthritis (KOA)

March 6, 2025 updated by: Cheng Liang, Chengdu Sport University
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).

Study Overview

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 Type

Interventional

Enrollment (Estimated)

120

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 Contact

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

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: 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:
  • Muscle Isometric Contraction
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

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

Investigators

  • Principal Investigator: Liang Cheng, Chengdu Sport University

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 (Estimated)

September 20, 2025

Primary Completion (Estimated)

September 20, 2025

Study Completion (Estimated)

September 20, 2025

Study Registration Dates

First Submitted

March 6, 2025

First Submitted That Met QC Criteria

March 6, 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 6, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

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)?

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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