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The Effect of Contralateral Isokinetic Lower Extremity Exercises in Unilateral Painful Knee Osteoarthritis

The Effect of Contralateral Isokinetic Lower Extremity Exercises Added to Conventional Rehabilitation in Unilateral Painful Knee Osteoarthritis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06675318
Enrollment
32
Registered
2024-11-05
Start date
2022-11-30
Completion date
2023-08-31
Last updated
2024-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exercise, Osteoarthritis, Knee

Keywords

Knee osteoarthritis, Isokinetic exercise, Contralateral exercise effect, Quadriceps muscle thickness, Physical Function, Quality of life

Brief summary

Patients with unilateral knee pain due to knee osteoarthritis presenting to our clinic will be included in a 20-session treatment program, either on an outpatient basis or as inpatients at our clinic. The patients will be divided into 2 groups, and conventional treatments including isometric exercises, TENS (Transcutaneous Electrical Nerve Stimulation) and hot pack therapy for the painful knee will be administered to both groups. In addition to these treatments, the intervention group will receive isokinetic exercise sessions using the Cybex 770 Norm isokinetic dynamometer system (Lumex Inc., Ronkonkoma, New York) at speeds of 60°/s and 180°/s according to the device's standard protocol, targeting the contralateral lower extremity. Subsequently, examinations and measurements will be conducted to evaluate patients for reduction in pain, increase in muscle strength, improvement in functionality, and increase in thigh muscle thickness.

Detailed description

Osteoartritis is the most common form of arthritis, originating from the failed repair of joint damage caused by stress initiated by any joint or periarticular tissue abnormality. Its most common symptom is pain. The long-term consequences of osteoarthritis include decreased physical activity, loss of conditioning, sleep disturbances, fatigue, depression, and disability. Factors associated with increased risk of knee osteoarthritis include advanced age, female gender, overweight or obesity, knee injury, occupational factors, and varus or valgus alignment of the knee. With the increasing aging population, degenerative joint problems have become relevant to a large portion of society. Exercise is a fundamental component in the treatment of this chronic disease, which limits functionality and reduces quality of life. A systematic review including 32 randomized controlled trials evaluating 5362 participants showed that various types of exercise provide improvement in pain, functionality, and quality of life in knee osteoarthritis. Musculoskeletal pains can lead to cortical reorganization in both somatosensory and motor areas, which can reduce motor activity in both the affected and unaffected contralateral extremities. For example, a decrease in motor activity in both painful and pain-free contralateral extremities has been identified during acute pain and/or in the presence of chronic pain. If exercise is performed to increase muscle strength on one side of the body, strength may also increase on the opposite side. This effect, called the contralateral exercise phenomenon, is typically measured in homologous muscles. Although known for over a century, most studies have not been well-designed to demonstrate the exact magnitude of the strength increase effect. However, an updated meta-analysis of 16 studies indicates that the size of the contralateral exercise effect is approximately 8% of baseline strength or about half of the increase in strength on the exercised side. However, there are few studies examining the combined effects of contralateral lower extremity isokinetic exercises on pain, muscle thickness, and functionality. Therefore, the aim of this study is to demonstrate the effect of isokinetic exercises applied to the contralateral lower extremity added to routine treatment on muscle strength, muscle thickness, and functionality in the painful knee, and to show its potential relationship. We aim to provide clinicians with a new perspective on the treatment of knee osteoarthritis.

Interventions

OTHERCross training for quadriceps muscle of contralateral lower limb

An isokinetic exercise program consisting of 20 sessions conducted five days a week. The program begins with five repetitions at a speed of 60°/s, followed by sets of 5-15 repetitions with incremental increases of 30°/s. Rest periods of 30 seconds were included between sets.

OTHERQuadriceps isometric exercises, along with hot pack and TENS for painful knee

10 repetitions of quadriceps isometric exercises in 3 sets, along with hot pack and TENS treatments for painful knee

Sponsors

Gazi University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

Clinical and demographic data collection and statistical analyses will be conducted by a blinded researcher with respect to the treatment group and clinical findings.

Intervention model description

A prospective cohort study involving two parallel groups with randomization control

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* To agree to participate in the study * To be aged 50 years or older * To have a clinically and radiographically confirmed diagnosis of knee osteoarthritis * To have unilateral knee pain due to osteoarthritis (VAS \<2 in the contralateral knee, VAS \>2 in the painful knee) * To have Kellgren-Lawrence Grade 1-3 in the painful knee and Kellgren-Lawrence Grade \<4 in the contralateral knee * To have dominance of the right lower extremity

Exclusion criteria

* A history of previous lower extremity fractures or orthopedic surgery that would interfere with isokinetic and isometric exercises in both lower extremities * The presence of significant sensorimotor deficits due to neurological diseases * The presence of known inflammatory rheumatic diseases * The presence of non-curable malignant tumors with bone metastasis * The presence of neuropsychiatric diseases or conditions that would hinder cooperation * Having undergone interventions such as injections for pain relief within the last 3 months

Design outcomes

Primary

MeasureTime frameDescription
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) scoreFrom enrollment day to the end of the rehabilitation program at 4 weeks.WOMAC score evaluation following the last treatment session. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a widely used, validated questionnaire designed to assess pain, stiffness, and physical function in patients with knee and hip osteoarthritis. It consists of 24 items divided into three subscales: pain (5 items), stiffness (2 items), and physical function (17 items). Patients rate their symptoms on a Likert scale, with higher scores indicating worse pain, stiffness, or functional limitations. The WOMAC is commonly used in clinical research to evaluate the efficacy of various treatments for osteoarthritis.

Secondary

MeasureTime frameDescription
Muscle strengthFrom enrollment day to the end of the rehabilitation program at 4 weeksTo evaluate isokinetic muscle strength, the Cybex 770 Norm isokinetic dynamometer system (Lumex Inc., Ronkonkoma, New York) will be used to measure peak torque values for flexion and extension at a speed of 60°/s, peak torque values for flexion and extension at a speed of 180°/s, and total work production (endurance) at 180 degrees.
Physical functionFrom enrollment day to the end of the rehabilitation program at 4 weeksTo evaluate physical function, SF-36 (Short Form-36) will be used. SF-36: The SF-36 is a scale consisting of 36 items divided into 8 subscales: physical functioning, physical role, emotional role, pain, general health, energy, social functioning, and mental health. Lower scores indicate higher levels of restriction. The Turkish version has been validated for reliability and validity.
Pain level; VAS scoreFrom enrollment day to the end of the rehabilitation program at 4 weeksThe Visual Analog Scale (VAS) is a tool used to measure a patient's level of pain. It consists of a straight line with endpoints defining extreme limits such as 'no pain' and 'worst pain imaginable.' The patient marks on the line the point that they feel represents their perception of their current state. This method is simple, reliable, and widely used in both clinical and research settings to quantify pain intensity.
Ultrasonographic Measurement of Thigh muscle thicknessFrom enrollment day to the end of the rehabilitation program at 4 weeksParticipants will be evaluated in a supine position. Measurements will be taken for the Rectus Femoris (RF), Vastus Intermedius (VI), Vastus Lateralis (VL), Vastus Medialis (VM), and Vastus Medialis Obliquus (VMO) muscles. A line will be drawn from the upper pole of the patella to the anterior superior iliac spine (ASIS) along the length of the thigh. RF and VI will be measured at 50% of this line. For VL, the circumference of the thigh at 50% of the line will be measured, and then VL will be measured at 10% of the circumference. VM will be measured at 20% of the line, and then at 12.5% of the circumference at the same point. VMO will be measured 4 cm above and 3 cm medial to the upper pole of the patella. MyLab 70 XV ultrasound device (Esaote Biomedica, Genoa, Italy) with a multifrequency linear probe will be used at the Physical Medicine and Rehabilitation Unit of Gazi University Faculty of Medicine.
Range of motionFrom enrollment day to the end of the rehabilitation program at 4 weeksRange of motion will be measured with a goniometer according to the neutral zero method. The principle of joint measurement by the neutral zero method is to measure the movement of a joint from a defined neutral O-position. The measured angle gives the magnitude of movement.
Lower extremity functionFrom enrollment day to the end of the rehabilitation program at 4 weeksTo evaluate physical function, TUG test will be used. Timed Up and Go Test (TUG): To assess lower extremity function, participants will be timed as they rise from a chair, walk to a marked point 3 meters away, turn around, and return to sit in the chair. The elapsed time will be recorded.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026