NCT07471204

Brief Summary

Knee osteoarthritis (OA) is a degenerative joint disease characterized by pain, muscle weakness, and functional limitations that significantly affect lower limb muscle performance. Structural and physiological alterations in the quadriceps muscle, particularly in the vastus medialis obliquus (VMO), have been reported in individuals with knee OA, including reductions in muscle cross-sectional area, intramuscular fat infiltration, vascular changes, and impaired neuromuscular activation. Muscle oxygenation (SmO₂) is an objective indicator of the metabolic status and circulatory capacity of skeletal muscle. However, the oxygenation dynamics of the quadriceps muscle before and after exercise in individuals with knee OA have not been sufficiently investigated. The aim of this study is to evaluate VMO muscle oxygenation at rest, during exercise, and during the recovery period in individuals with knee OA and to compare these parameters with age- and sex-matched healthy individuals. In addition, the study will examine the relationship between muscle oxygenation parameters, muscle strength, functional performance, and pain levels. Understanding these physiological responses may provide insight into the metabolic mechanisms underlying muscle dysfunction in knee OA and may contribute to the development of more individualized rehabilitation strategies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2026

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 13, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2026

Completed
Last Updated

June 15, 2026

Status Verified

June 1, 2026

Enrollment Period

3 months

First QC Date

March 10, 2026

Last Update Submit

June 12, 2026

Conditions

Keywords

Osteoarthritis of KneeMuscle oxygenationMuscle StrengthPain

Outcome Measures

Primary Outcomes (1)

  • Muscle Oxygenation

    Muscle oxygenation (SmO₂) of the vastus medialis obliquus will be measured using near-infrared spectroscopy (Moxy Monitor, Fortiori Design LLC, USA). SmO₂ values will be recorded at rest (baseline), immediately after the mini-squat exercise, and throughout the recovery period. The primary outcome will include the magnitude of SmO₂ change following exercise and the recovery time required for SmO₂ to return to its baseline value.

    Measured during the single assessment session

Secondary Outcomes (3)

  • Maximal Isometric Quadriceps Strength

    Measured during the single assessment session

  • Functional Performance - 30-Second Sit-to-Stand Test

    Measured during the single assessment session

  • Pain Intensity

    Measured before the assessment session

Study Arms (2)

Knee Osteoarthritis

Participants diagnosed with bilateral knee osteoarthritis according to the American College of Rheumatology criteria and classified as Kellgren-Lawrence grade 2-3.

Other: No intervention

Healthy Controles

Age- and sex-matched healthy individuals without knee osteoarthritis or lower extremity musculoskeletal disorders.

Other: No intervention

Interventions

15-repetition mini-squat exercise is used only as an assessment task.

Healthy ControlesKnee Osteoarthritis

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of adults aged 45-65 years, including individuals diagnosed with knee osteoarthritis (Kellgren-Lawrence grade 2-3) according to the American College of Rheumatology criteria and age- and sex-matched healthy controls. All participants will meet the predefined eligibility criteria and provide written informed consent prior to participation.

You may qualify if:

  • Age between 45 and 65 years
  • Body mass index (BMI) below 30 kg/m²
  • Willingness to participate in the study
  • Additional criteria for the knee osteoarthritis group:
  • Diagnosis of knee osteoarthritis confirmed by a physician according to the American College of Rheumatology diagnostic criteria
  • Bilateral knee osteoarthritis classified as Kellgren-Lawrence grade 2 or 3

You may not qualify if:

  • Presence of another orthopedic or rheumatologic condition affecting the lower extremity
  • Uncontrolled hypertension
  • Presence of lower extremity arterial or venous disorders
  • Presence of a neurological disease
  • Cognitive, learning, or perception impairments
  • Knee extension deficit
  • Physical activity level exceeding 600 MET-min/week according to the International Physical Activity Questionnaire Short Form (IPAQ-SF)
  • Participation in a physiotherapy and rehabilitation program for knee osteoarthritis within the last 6 months
  • Intra-articular knee injection within the past 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpaşa, Faculty of Health Sciences, Physiotherapy and Rehabilitation Lab.

Istanbul, Büyükçekmece, 34000, Turkey (Türkiye)

Location

Related Publications (11)

  • Daşkapan, A., KÜLÜNKOĞLU, B., Özünlü Pekyavaş, N., Tüzün, E., Nur Coşar, S., & Karataş, M.; Comparison of mini-squats and straight leg raises in patients with knee osteoarthritis: A randomized controlled clinical trial; Turkish Journal of Rheumatology; 2013; 28(1); 016-026.

    BACKGROUND
  • Earl JE, Schmitz RJ, Arnold BL. Activation of the VMO and VL during dynamic mini-squat exercises with and without isometric hip adduction. J Electromyogr Kinesiol. 2001 Dec;11(6):381-6. doi: 10.1016/s1050-6411(01)00024-4.

    PMID: 11738950BACKGROUND
  • Edwards MH, van der Pas S, Denkinger MD, Parsons C, Jameson KA, Schaap L, Zambon S, Castell MV, Herbolsheimer F, Nasell H, Sanchez-Martinez M, Otero A, Nikolaus T, van Schoor NM, Pedersen NL, Maggi S, Deeg DJ, Cooper C, Dennison E. Relationships between physical performance and knee and hip osteoarthritis: findings from the European Project on Osteoarthritis (EPOSA). Age Ageing. 2014 Nov;43(6):806-13. doi: 10.1093/ageing/afu068. Epub 2014 Jun 10.

    PMID: 24918169BACKGROUND
  • Alghadir AH, Anwer S, Iqbal A, Iqbal ZA. Test-retest reliability, validity, and minimum detectable change of visual analog, numerical rating, and verbal rating scales for measurement of osteoarthritic knee pain. J Pain Res. 2018 Apr 26;11:851-856. doi: 10.2147/JPR.S158847. eCollection 2018.

    PMID: 29731662BACKGROUND
  • Jun, I., Lee, Y., Shin, C.; The effects of isometric extension at different knee angles on vastus medialis electromyographic activity in patients with knee joint osteoarthritis; Journal of Physical Therapy Science; 2012; 24 (9), 855-857.

    BACKGROUND
  • Carpenter MR, Carpenter RL, Peel J, Zukley LM, Angelopoulou KM, Fischer I, Angelopoulos TJ, Rippe JM. The reliability of isokinetic and isometric leg strength measures among individuals with symptoms of mild osteoarthritis. J Sports Med Phys Fitness. 2006 Dec;46(4):585-9.

    PMID: 17119524BACKGROUND
  • Feldmann A, Schmitz R, Erlacher D. Near-infrared spectroscopy-derived muscle oxygen saturation on a 0% to 100% scale: reliability and validity of the Moxy Monitor. J Biomed Opt. 2019 Nov;24(11):1-11. doi: 10.1117/1.JBO.24.11.115001.

    PMID: 31741352BACKGROUND
  • Crum EM, O'Connor WJ, Van Loo L, Valckx M, Stannard SR. Validity and reliability of the Moxy oxygen monitor during incremental cycling exercise. Eur J Sport Sci. 2017 Sep;17(8):1037-1043. doi: 10.1080/17461391.2017.1330899. Epub 2017 May 30.

    PMID: 28557670BACKGROUND
  • Hunter DJ, Bierma-Zeinstra S. Osteoarthritis. Lancet. 2019 Apr 27;393(10182):1745-1759. doi: 10.1016/S0140-6736(19)30417-9.

    PMID: 31034380BACKGROUND
  • Taniguchi M, Fukumoto Y, Yagi M, Hirono T, Yamagata M, Asayama A, Okada S, Nakai R, Kobayashi M, Ichihashi N. A higher intramuscular fat in vastus medialis is associated with functional disabilities and symptoms in early stage of knee osteoarthritis: a case-control study. Arthritis Res Ther. 2023 Apr 14;25(1):61. doi: 10.1186/s13075-023-03048-0.

    PMID: 37060080BACKGROUND
  • Noehren B, Kosmac K, Walton RG, Murach KA, Lyles MF, Loeser RF, Peterson CA, Messier SP. Alterations in quadriceps muscle cellular and molecular properties in adults with moderate knee osteoarthritis. Osteoarthritis Cartilage. 2018 Oct;26(10):1359-1368. doi: 10.1016/j.joca.2018.05.011. Epub 2018 May 23.

    PMID: 29800621BACKGROUND

Related Links

MeSH Terms

Conditions

Osteoarthritis, KneePain

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ayşem Ecem Özdemir, PT, Msc

    Bahçeşehir University

    PRINCIPAL INVESTIGATOR
  • Yıldız Analay Akbaba, PT, PhD

    Istanbul University - Cerrahpasa

    STUDY CHAIR
  • Gökhan Özkoçak, MD, PhD

    Istanbul Aydın University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Msc. PT.

Study Record Dates

First Submitted

March 10, 2026

First Posted

March 13, 2026

Study Start

March 1, 2026

Primary Completion

June 5, 2026

Study Completion

June 5, 2026

Last Updated

June 15, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations