- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04828200
The Presence Of Sarcopenia In Patients With Knee Osteoarthritis
Multi-Dimensional Evaluation Of The Presence Of Sarcopenia In Patients With Knee Osteoarthritis
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Çankaya/turkey
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Ankara, Çankaya/turkey, Turkey, 06100
- Gaziler PMR, Training and Research Hospital, Department of PMR
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Patients between the ages of 50-70
- Patients who have been followed up with the diagnosis of knee ostheoarthritis
- Patients who have been followed up with the diagnosis of knee ostheoarthritis and sarcopenia
Exclusion Criteria:
- Previous history of any trauma/surgical history of the lower extremities (other than amputation)
- Rheumatic diseases Contracture of the knee and the ankle of the intact limb
- malignant disease
- hyperthyroidism/ hypothyroidism
- chronic inflammatory disease
- diabetes mellitus, and uncontrollable heart and kidney diseases
- pregnant women
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
sarcopenic patints with knee ostheoarthritis
12 patients between the ages of 50-70, who have been followed up with the diagnosis of knee Ostheoarthritis (OA) patients with sarcopenia.All subjects were evaluated by the European Working Group on Sarcopenia in Older People (EWGSOP) diagnostic criteria for the diagnosis of sarcopenia.
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The ultrasonographic assesment will be used to examine the rectus femoris, gastrocnemius medailalis and rectus abdominis subcutaneous and muscle thickness.
Additionally, fascicle length and pennation angle were measured between the two parallel aponeuroses of the gastrocnemius muscle (bulkiest part of medial head) in the longitudinal view when subjects were in prone position with their ankles at 90°.
The muscle masses of the patients were evaluated by measuring the fat mass (Fat Mass-FM), fat mass index (FMI), lean body mass (LBM) and skeletal muscle index (SMI) calculated by DEXA.
Appendicular muscle mass (ASM) is calculated by summing the lean soft tissue of the two upper limbs and the two lower limbs.
Skeletal muscle mass index is calculated by dividing the appendicular lean mass by the square of the neck height [SMI = ASM / height2 (kg / m2)].
Quadriceps-hamstring Peak Torque (PT) values and the ratio of PT values to body weight (PT / VA) (at 60 and 180 ° / sec speeds) were evaluated with an isokinetic dynamometer
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non sarcopenic patients with knee ostheoarthritis
90 patients between the ages of 50-70, who have been followed up with the diagnosis of knee Ostheoarthritis (OA) patients.
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The ultrasonographic assesment will be used to examine the rectus femoris, gastrocnemius medailalis and rectus abdominis subcutaneous and muscle thickness.
Additionally, fascicle length and pennation angle were measured between the two parallel aponeuroses of the gastrocnemius muscle (bulkiest part of medial head) in the longitudinal view when subjects were in prone position with their ankles at 90°.
The muscle masses of the patients were evaluated by measuring the fat mass (Fat Mass-FM), fat mass index (FMI), lean body mass (LBM) and skeletal muscle index (SMI) calculated by DEXA.
Appendicular muscle mass (ASM) is calculated by summing the lean soft tissue of the two upper limbs and the two lower limbs.
Skeletal muscle mass index is calculated by dividing the appendicular lean mass by the square of the neck height [SMI = ASM / height2 (kg / m2)].
Quadriceps-hamstring Peak Torque (PT) values and the ratio of PT values to body weight (PT / VA) (at 60 and 180 ° / sec speeds) were evaluated with an isokinetic dynamometer
|
control group
33 patients between the ages of 50-70, who have been followed up not being exposed to be sarcopenia or knee OA
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The ultrasonographic assesment will be used to examine the rectus femoris, gastrocnemius medailalis and rectus abdominis subcutaneous and muscle thickness.
Additionally, fascicle length and pennation angle were measured between the two parallel aponeuroses of the gastrocnemius muscle (bulkiest part of medial head) in the longitudinal view when subjects were in prone position with their ankles at 90°.
The muscle masses of the patients were evaluated by measuring the fat mass (Fat Mass-FM), fat mass index (FMI), lean body mass (LBM) and skeletal muscle index (SMI) calculated by DEXA.
Appendicular muscle mass (ASM) is calculated by summing the lean soft tissue of the two upper limbs and the two lower limbs.
Skeletal muscle mass index is calculated by dividing the appendicular lean mass by the square of the neck height [SMI = ASM / height2 (kg / m2)].
Quadriceps-hamstring Peak Torque (PT) values and the ratio of PT values to body weight (PT / VA) (at 60 and 180 ° / sec speeds) were evaluated with an isokinetic dynamometer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Musculoskeletal ultrasonography
Time Frame: through study completion, an average of one and a half months
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Rectus femoris, Rectus abdominis and gastrocnemius subcutaneosus and muscle thickness measurements will be performed by using ultrasound.
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through study completion, an average of one and a half months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time Frame: through study completion, an average of one and a half months
|
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The WOMAC is scored on a best to worst scale, so that lower subscale scores represent less pain, less stiffness, or better physical function. |
through study completion, an average of one and a half months
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Short Form-36 (SF-36)
Time Frame: through study completion, an average of one and a half months
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The health-related quality of life of the subjects will be evaluated with Short Form-36 (SF-36).
This comprises 36 questions related to eight different subscales, physical functioning, bodily pain, role limitation, due to physical health problems, general health perceptions, vitality, energy and fatigue, role limitations due to emotional problems, social functioning and general mental health, which covers psychological distress and wellbeing.
Each of eight subscales is scored between 0 and 100, with higher scores indicating a better quality of life.
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through study completion, an average of one and a half months
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The Center for Epidemiologic Studies Depression Scale (CES-D scale)
Time Frame: through study completion, an average of one and a half months
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The CES-D scale is a brief self-report scale designed to measure self-reported symptoms associated with depression experienced in the past week.
The items of the scale are symptoms associated with depression which have been used in previously validated longer scales.
TheCES-D contains 20 items that can be responded to on a four-point Likert scale, with response categories ranging from 'rarely or none of the time' (0 points) to 'most or all of the times' (3 points) which are summed up to a total score where higher score indicate more severe depressive symptoms.
A cut-off score of ≥ 16 is generally accepted as indicator for clinical meaningful depressive symptoms.
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through study completion, an average of one and a half months
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The timed 'Up & Go' test
Time Frame: through study completion, an average of one and a half months
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The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance.
It uses the time that a person takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees.
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through study completion, an average of one and a half months
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International Assessment Questionnaire Short Form (IPAQ-SF)
Time Frame: through study completion, an average of one and a half months
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This measure assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting. 2 METS is twice what you expend at rest.
Data collected with IPAQ can be reported as a continuous measure and reported as median METminutes.
Median values can be computed for walking (W), moderate-intensity activities (M), and vigorous-intensity activities (V) using the following formulas: Walking MET-minutes/week = 3.3 * walking minutes * walking/days, Moderate MET-minutes/week = 4.0 * moderate-intensity activity minutes * moderate days Vigorous MET-minutes/week = 8.0 * vigorous-intensity activity minutes * vigorous-intensity days.
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through study completion, an average of one and a half months
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Mini-Nutritional Assessment (MNA-SF)
Time Frame: through study completion, an average of one and a half months
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The MNA® is a validated nutrition screening and assessment tool that can identify geriatric patients age 65 and above who are malnourished or at risk of malnutrition.
|
through study completion, an average of one and a half months
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Collaborators and Investigators
Investigators
- Principal Investigator: Sefa gümrük aslan, Gaziler Physical Medicine And Rehabilitation Health Application And Research Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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