NCT06870656

Brief 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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 11, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

September 20, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2025

Completed
Last Updated

March 11, 2025

Status Verified

March 1, 2025

Enrollment Period

Same day

First QC Date

March 6, 2025

Last Update Submit

March 6, 2025

Conditions

Keywords

KOAMuscle isometric contraction

Outcome Measures

Primary Outcomes (7)

  • 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).

    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.

    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.

    16 weeks

  • Proprioception

    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

    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

    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

    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

Study Arms (4)

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.

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.

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.

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.

Interventions

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.

Also known as: Muscle Isometric Contraction
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 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.

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 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.

High-intensity group

Eligibility Criteria

Age60 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Cardiovascular diseases;
  • Need for surgery or pharmacological treatment in the near future;
  • Neuromuscular diseases;
  • Currently engaged in regular exercise.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Isometric Contraction

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Muscle ContractionMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Liang Cheng

    Chengdu Sport University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

March 6, 2025

First Posted

March 11, 2025

Study Start

September 20, 2025

Primary Completion

September 20, 2025

Study Completion

September 20, 2025

Last Updated

March 11, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share