The Presence Of Sarcopenia In Patients With Knee Osteoarthritis

Osteoarthritis Clinical Trial

Official title:

Multi-Dimensional Evaluation Of The Presence Of Sarcopenia In Patients With Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04828200
• Other study ID #: 2
• Status: Completed
• Start date: April 10, 2016
• Est. completion date: September 10, 2016

Study information

• Verified date: April 2021
• Source: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Osteoarthritis (OA) is one of the most common joint disorders worldwide . The knee is the most common symptomatic joint in osteoarthritis. In this study, we evaluated the presence of sarcopenia multidimensionally in patients with knee osteoarthritis (OA) using clinical, ultrasonographic and biochemical parameters, and in this respect, it was aimed to investigate the relation between OA and sarcopenia and to identify the most practical, easily accessible and inexpensive method for investigating sarcopenia.

Description:

102 patients with clinical and radiological diagnosis of knee osteoarthritis and 33 healthy control subjects were included in the study. A total of 135 subjects were evaluated using the European Working Group on Sarcopenia in Older People (EWGSOP) diagnostic criteria of sarcopenia. The first group consists of (OA) patients with sarcopenia, the second group consist of OA patients without sarcopenia and the third group is controls subjects. The detailed musculoskeletal system examination of the patients included in the study was carried out by a single physician, and complete blood count, renal function tests, electrolytes, total protein, albumin, 25 (OH) vitamin D, serum leptin, serum adiponectin, PTH, TSH and vitamin B12 values were recorded using the venous blood samples taken from the study group.Dual-X-ray absorptiometry (DEXA) is used to measure Body composition parameters and muscle mass measurements, isometric muscle strength evaluations, handgrip strength and gait speeds for diagnosis of sarcopenia. Short-form -36 (SF-36) The Nutritional Assessment-short form (MNA), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the International Physical Assessment Questionnaire Short Form (IPAQ-SF) and the Center for Epidemiologic Studies Depression Scale (CES-D scale) were administered to every patient as outcome measures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: September 10, 2016
• Est. primary completion date: September 10, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee
• Sarcopenia

Intervention

Diagnostic Test:
• Musculoskeletal ultrasound
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°.
• Dual-X-ray absorptiometry
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)].
• Isokinetic dynamometer
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

Locations

Country	Name	City	State
Turkey	Gaziler PMR, Training and Research Hospital, Department of PMR	Ankara	Çankaya/turkey

Sponsors (1)

Lead Sponsor	Collaborator
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Musculoskeletal ultrasonography	Rectus femoris, Rectus abdominis and gastrocnemius subcutaneosus and muscle thickness measurements will be performed by using ultrasound.	through study completion, an average of one and a half months
Secondary	The Western Ontario and McMaster Universities Arthritis Index (WOMAC)	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
Secondary	Short Form-36 (SF-36)	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.	through study completion, an average of one and a half months
Secondary	The Center for Epidemiologic Studies Depression Scale (CES-D scale)	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.	through study completion, an average of one and a half months
Secondary	The timed 'Up & Go' test	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.	through study completion, an average of one and a half months
Secondary	International Assessment Questionnaire Short Form (IPAQ-SF)	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.	through study completion, an average of one and a half months
Secondary	Mini-Nutritional Assessment (MNA-SF)	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