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Comparison of the Effects of Two Different Home Exercise Programs on Femoral Cartilage Thickness and Clinical Parameters in Individuals With Knee Osteoarthritis: A Randomized Controlled Trial

14 de junio de 2026 actualizado por: MERVE ARBAY, Pamukkale University

Knee osteoarthritis (OA) is one of the most common joint disorders worldwide and is a leading cause of pain, limited mobility, and functional disability, particularly in the elderly population (1). According to 2020 data, approximately 654 million individuals aged 40 years and older are affected by knee OA worldwide, with a global prevalence of 22.9% in this age group (2). In our country as well, OA is reported as the second most common rheumatologic disease. The disease not only negatively affects individuals' quality of life but also creates a significant socioeconomic burden through work loss, hospital admissions, and the need for surgical interventions (3).

The pathogenesis of knee OA is a complex process involving articular cartilage degeneration, subchondral bone sclerosis, synovial tissue proliferation, and osteophyte formation. Once cartilage damage begins, its capacity for spontaneous healing is extremely limited; therefore, early interventions aimed at slowing or halting disease progression are of critical importance (4,5). In this context, non-pharmacological interventions, particularly exercise programs that may contribute to maintaining cartilage integrity, are strongly recommended as first-line treatment options in current clinical guidelines (6-8).

The beneficial effects of exercise therapy on pain and function in patients with knee OA are well documented. However, the structural effects of exercise on femoral cartilage thickness have been relatively less investigated. Tuna et al. evaluated femoral cartilage thickness using ultrasonography in 40 patients with knee OA following a 12-week quadriceps strengthening program and reported statistically significant increases in cartilage thickness in the medial condyle, lateral condyle, and intercondylar region at 3 months (9). This pioneering study suggests that muscle strengthening programs may have not only symptomatic but also structural benefits. Similarly, Bozan et al. reported a strong positive correlation between quadriceps muscle thickness (rectus femoris + vastus intermedius) and femoral cartilage thickness, supporting the idea that muscle loss parallels cartilage degeneration (10). However, these studies focused exclusively on the quadriceps muscle, and the effects of hip musculature on femoral cartilage thickness have not been investigated. Recent biomechanical studies indicate that hip abductor and adductor muscles play a critical role in knee joint loading patterns.

Hip abductor muscles provide pelvic stability during gait and directly influence knee adduction moments. Weakness of the gluteus medius leads to contralateral pelvic drop, increasing medial compartment loading on the ipsilateral knee and accelerating medial tibiofemoral cartilage wear (11-14). Indeed, Segal et al., using data from the Multicenter Osteoarthritis Study (MOST), demonstrated via MRI that greater hip abductor strength significantly reduces the risk of progression of medial patellofemoral and lateral tibiofemoral cartilage damage (15). On the other hand, hip adductor muscles are also thought to contribute to knee adduction moments by eccentrically controlling femoral varus motion; however, this relationship has been studied far less compared to quadriceps and abductors (13,16-18).

Systematic reviews and meta-analyses have shown that individuals with knee OA have up to 24% lower isometric hip abductor strength compared to healthy controls (13,14,19). Randomized controlled trials investigating combined hip and quadriceps strengthening programs have reported significant improvements in pain and function. However, none of these studies have used femoral cartilage thickness measured by ultrasonography as a primary outcome.

A review of the current literature reveals that although studies exist examining the effects of quadriceps strengthening on femoral cartilage thickness, no randomized controlled trial has compared hip abductor and adductor strengthening exercises with a quadriceps strengthening program, using ultrasonographic femoral cartilage thickness as the primary outcome measure. This study aims to address this gap. All interventions will be applied as non-invasive home exercise programs, and all measurements will be performed using ultrasonography. Baseline, 1-month, and 3-month assessments will also allow evaluation of the temporal effects of exercise on cartilage structure. The findings are expected to provide scientific evidence regarding the structural protective effects of hip exercises in knee OA rehabilitation and serve as pilot data for future large-scale multicenter studies.

The aim of this study is to compare patients with knee OA receiving quadriceps strengthening exercises alone with those receiving additional hip abductor/adductor strengthening exercises in terms of changes in femoral cartilage thickness, and to evaluate whether there is a correlation between femoral cartilage thickness and the thickness of the rectus femoris, gluteus medius,

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Estimado)

56

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Merve Arbay Celtek
  • Número de teléfono: • +905343371877
  • Correo electrónico: arbaymerve@gmail.com

Ubicaciones de estudio

      • Kütahya, Turquía (Türkiye)
        • Kütahya Physical Therapy and Rehabilitation Hospital
        • Contacto:
        • Sub-Investigador:
          • Hasan Celtek

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  1. Age ≥18 years
  2. Diagnosis of knee osteoarthritis according to ACR criteria, Kellgren-Lawrence grade 2-3
  3. Knee pain for at least 3 months
  4. Having the physical capacity to perform a home exercise program
  5. Willingness to provide written informed consent

Exclusion Criteria:

  1. History of knee, hip, or spine surgery
  2. Active inflammatory arthritis (e.g., rheumatoid arthritis, gout, psoriatic arthritis)
  3. Intra-articular injection within the last 3 months
  4. Neurological or neuromuscular disorders
  5. Body mass index (BMI) > 40 kg/m²
  6. Pregnancy
  7. Cardiovascular or orthopedic contraindications preventing participation in a regular exercise program
  8. Cognitive impairment

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Quadriceps Plus Hip Strengthening Group

For 3 months, 3 days per week, participants will perform quadriceps strengthening exercises combined with hip abductor and adductor strengthening exercises.

In addition to all exercises included in the Quadriceps Strengthening Group, participants will perform:

Hip abduction (side-lying position with ankle weights) Clamshell exercise (for gluteus medius activation) Hip adduction (supine position with isometric contraction using a pillow) Side-lying hip abduction with a resistance band

quadriceps strengthening exercises combined with hip abductor and adductor strengthening exercises
Comparador activo: Quadriceps Strengthening Group

For 3 months, 3 days per week, participants will perform a quadriceps strengthening exercise program only.

The program will include:

Knee extension (in a seated position, with and without resistance) Terminal knee extension Straight leg raise Mini squat (0-30° knee flexion)

quadriceps strengthening exercise program

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Medial femoral condyle cartilage thickness (mm)
Periodo de tiempo: Participants receiving treatment will be evaluated at baseline (T0), at Month 1 (T1), and at Month 3 (T2).
All ultrasonographic measurements will be performed using a Clarius L7 HD3 linear high-frequency transducer (7.5-12 MHz) with the knee positioned in 90° flexion in a standardized manner. Three measurements will be obtained at each anatomical location, and the mean value will be recorded for analysis.
Participants receiving treatment will be evaluated at baseline (T0), at Month 1 (T1), and at Month 3 (T2).

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Lateral femoral condyle cartilage thickness (mm)
Periodo de tiempo: Participants receiving treatment will be evaluated at baseline (T0), at Month 1 (T1), and at Month 3 (T2).
All ultrasonographic measurements will be performed using a Clarius L7 HD3 linear high-frequency transducer (7.5-12 MHz) with the knee positioned in 90° flexion in a standardized manner. Three measurements will be obtained at each anatomical location, and the mean value will be recorded for analysis.
Participants receiving treatment will be evaluated at baseline (T0), at Month 1 (T1), and at Month 3 (T2).
Intercondylar area cartilage thickness (mm)
Periodo de tiempo: Participants receiving treatment will be evaluated at baseline (T0), at Month 1 (T1), and at Month 3 (T2).
All ultrasonographic measurements will be performed using a Clarius L7 HD3 linear high-frequency transducer (7.5-12 MHz) with the knee positioned in 90° flexion in a standardized manner. Three measurements will be obtained at each anatomical location, and the mean value will be recorded for analysis.
Participants receiving treatment will be evaluated at baseline (T0), at Month 1 (T1), and at Month 3 (T2).
Ultrasound Femoral Cartilage Degeneration Grade
Periodo de tiempo: Participants receiving treatment will be evaluated at baseline (T0), at Month 1 (T1), and at Month 3 (T2).

Evaluation will be performed with the symptomatic knee positioned in maximum flexion.

Cartilage degeneration will be classified as follows:

Grade 1: Blurred margins or partial loss of sharpness without thickness change Grade 2: Blurred margin space with partial loss of sharpness without thickness change Grade 3: Blurred margins with loss of clarity Grade 4: Poorly defined margins with a completely opaque band Grade 5: Evident thickness alteration Grade 6: Cartilage band cannot be visualized

Participants receiving treatment will be evaluated at baseline (T0), at Month 1 (T1), and at Month 3 (T2).
Synovial Hypertrophy Grade
Periodo de tiempo: Participants receiving treatment will be evaluated at baseline (T0), at Month 1 (T1), and at Month 3 (T2).

Ultrasound assessment will be performed in accordance with the EULAR and Outcome Measures in Rheumatology Clinical Trials (OMERACT) guidelines using both longitudinal and axial views.

For evaluation of synovial hypertrophy, the suprapatellar, medial parapatellar, and lateral parapatellar recesses will be scanned with the knee positioned in 30° flexion.

Synovial hypertrophy will be graded as follows:

Grade 0: No synovial thickening Grade 1: Mild synovial thickening Grade 2: Moderate synovial thickening Grade 3: Severe synovial thickening

Participants receiving treatment will be evaluated at baseline (T0), at Month 1 (T1), and at Month 3 (T2).
Rectus femoris muscle thickness (cm)
Periodo de tiempo: Participants receiving treatment will be evaluated at baseline (T0), at Month 1 (T1), and at Month 3 (T2).
Rectus femoris muscle thickness will be measured with the participant in the supine position and with the hip and knee in extension. The ultrasound transducer will be placed axially over the muscle. Measurements will be obtained at the junction between the lower one-third and upper two-thirds of the distance from the anterior superior iliac spine (ASIS) to the superior pole of the patella, which will serve as the anatomical reference point.
Participants receiving treatment will be evaluated at baseline (T0), at Month 1 (T1), and at Month 3 (T2).
Gluteus medius (GMed) muscle thickness (cm)
Periodo de tiempo: Participants receiving treatment will be evaluated at baseline (T0), at Month 1 (T1), and at Month 3 (T2).
Participants will be positioned in side-lying with the left leg uppermost. The left hip region will be exposed, and a towel will be placed under the ankle to maintain a neutral alignment of the hip, knee, and ankle joints. To assess the gluteus medius muscle, the ultrasound transducer will be placed longitudinally on the lateral aspect of the hip, just superior to the greater trochanter, at the anterior one-quarter of the line connecting the anterior superior iliac spine (ASIS) and posterior superior iliac spine (PSIS).
Participants receiving treatment will be evaluated at baseline (T0), at Month 1 (T1), and at Month 3 (T2).
Adductor longus muscle thickness (cm)
Periodo de tiempo: Participants receiving treatment will be evaluated at baseline (T0), at Month 1 (T1), and at Month 3 (T2).
Participants will be positioned in the supine position, with the thigh in abduction and external rotation and the knee flexed to 20-30°. The knee will be supported with a rolled towel. Measurements will be obtained at the junction between the upper one-third and lower two-thirds of the distance from the pubic symphysis to the medial femoral epicondyle, which will serve as the anatomical reference point.
Participants receiving treatment will be evaluated at baseline (T0), at Month 1 (T1), and at Month 3 (T2).
Visual Analog Scale (VAS)
Periodo de tiempo: Participants receiving treatment will be evaluated at baseline (T0), at Month 1 (T1), and at Month 3 (T2).
The Visual Analog Scale is used to assess pain intensity. Participants will be asked to indicate the severity of their knee pain on a scale ranging from 0 (no pain) to 10 (worst imaginable pain) by selecting the point that best represents their pain level.
Participants receiving treatment will be evaluated at baseline (T0), at Month 1 (T1), and at Month 3 (T2).
WOMAC Osteoarthritis Index
Periodo de tiempo: Participants receiving treatment will be evaluated at baseline (T0), at Month 1 (T1), and at Month 3 (T2).
The WOMAC Osteoarthritis Index consists of 24 items rated on a 5-point Likert scale. It includes three subscales: pain, stiffness, and physical function. The pain subscale contains 5 items and is scored from 0 to 20. The stiffness subscale includes 2 items and is scored from 0 to 8. The physical function subscale consists of 17 items and is scored from 0 to 68. Higher scores indicate greater pain, increased stiffness, and poorer functional status. The Turkish validity and reliability study of the WOMAC scale was conducted by Tüzün et al.
Participants receiving treatment will be evaluated at baseline (T0), at Month 1 (T1), and at Month 3 (T2).

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Publicaciones y enlaces útiles

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Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

20 de agosto de 2026

Finalización primaria (Estimado)

1 de abril de 2027

Finalización del estudio (Estimado)

1 de julio de 2027

Fechas de registro del estudio

Enviado por primera vez

14 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

14 de junio de 2026

Publicado por primera vez (Actual)

18 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

14 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • PamukkaleU.ftr-MArbayCeltek-01

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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