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NCT Number: NCT06870656

Muscle Isometric Contraction for the Treatment of Knee Osteoarthritis

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).

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Key information

Conditions

Knee Osteoarthritis (Knee OA) Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

60 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

low-intensity group

Other

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

Medium-intensity group

Other

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 group

Other

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.

Primary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Shuwan Chang

CONTACT

[email protected]

18280314728

Sponsors and collaborators

Lead sponsor

Chengdu Sport University

Other

Registry information

Acronym: KOA

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 11, 2025
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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