SarcopeniaNCT04828200
The Presence Of Sarcopenia In Patients With Knee Osteoarthritis
An observational study of Sarcopenia and Osteoarthritis, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 50 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Osteoarthritis
- What is being tested?
- Musculoskeletal ultrasound, Dual-X-ray absorptiometry and Isokinetic dynamometer
- Type of treatment
- Injection or infusion
- How many people
- 135 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2016to 10 Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 102 patients ages 50 to 70 years were diagnosed with knee osteoarthritis according to the American College of Rheumatology criteria and 33 healthy volunteers were enrolled in this study.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziler PMR, Training and Research Hospital, Department of PMR
Ankara, Çankaya/turkey, 06100
About this study
Official title: Multi-Dimensional Evaluation Of The Presence Of Sarcopenia In Patients With Knee Osteoarthritis
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.
Read the detailed 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.
- Conditions
- Sarcopenia, Osteoarthritis
- Being tested
- Musculoskeletal ultrasound, Dual-X-ray absorptiometry, Isokinetic dynamometer
- Keywords
- Dual-X-ray absorptiometry, Sarcopenia, Knee osteoarthritis, ultrasonography
- Medical subject headings
- Sarcopenia, Osteoarthritis, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Musculoskeletal ultrasoundDiagnostic test
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 absorptiometryDiagnostic test
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 dynamometerDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Musculoskeletal ultrasound; Diagnostic Test: Dual-X-ray absorptiometry; Diagnostic Test: Isokinetic dynamometer | |
| 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. Receives: Diagnostic Test: Musculoskeletal ultrasound; Diagnostic Test: Dual-X-ray absorptiometry; Diagnostic Test: 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 Receives: Diagnostic Test: Musculoskeletal ultrasound; Diagnostic Test: Dual-X-ray absorptiometry; Diagnostic Test: Isokinetic dynamometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Musculoskeletal ultrasonography
Rectus femoris, Rectus abdominis and gastrocnemius subcutaneosus and muscle thickness measurements will be performed by using ultrasound.
Measured: through study completion, an average of one and a half months
Secondary outcomes (6)
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.
Measured: through study completion, an average of one and a half months
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.
Measured: through study completion, an average of one and a half months
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.
Measured: through study completion, an average of one and a half months
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.
Measured: through study completion, an average of one and a half months
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.
Measured: through study completion, an average of one and a half months
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.
Measured: through study completion, an average of one and a half months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start10 Apr 2016
- Primary completion10 Sep 2016
- Study completion10 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sefa Gümrük Aslan, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Investigators
- Sefa gümrük aslan, Principal investigator, Gaziler Physical Medicine And Rehabilitation Health Application And Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04828200
- Sponsor's protocol ID
- 2
- Status last verified
- Apr 2021
- First submitted
- 28 Mar 2021
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Dimensional Evaluation Of The Presence Of Sarcopenia In Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04828200
- Acronym / sponsor ID
- 2
- Conditions
- Sarcopenia, Osteoarthritis
- Keywords
- Dual-X-ray absorptiometry, Sarcopenia, Knee osteoarthritis, ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
- Study start
- 10 Apr 2016 (actual)
- Primary completion
- 10 Sep 2016 (actual)
- Study completion
- 10 Sep 2016 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| sarcopenic patints with knee ostheoarthritis | – | Diagnostic Test: Musculoskeletal ultrasound, Diagnostic Test: Dual-X-ray absorptiometry, Diagnostic Test: Isokinetic dynamometer12 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. |
| non sarcopenic patients with knee ostheoarthritis | – | Diagnostic Test: Musculoskeletal ultrasound, Diagnostic Test: Dual-X-ray absorptiometry, Diagnostic Test: Isokinetic dynamometer90 patients between the ages of 50-70, who have been followed up with the diagnosis of knee Ostheoarthritis (OA) patients. |
| control group | – | Diagnostic Test: Musculoskeletal ultrasound, Diagnostic Test: Dual-X-ray absorptiometry, Diagnostic Test: Isokinetic dynamometer33 patients between the ages of 50-70, who have been followed up not being exposed to be sarcopenia or knee OA |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 102 patients ages 50 to 70 years were diagnosed with knee osteoarthritis according to the American College of Rheumatology criteria and 33 healthy volunteers were enrolled in this study.
Key inclusion criteria (3 listed)
- Patients between the ages of 50-70
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Musculoskeletal ultrasoundThe 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°. | Diagnostic test | control group, non sarcopenic patients with knee ostheoarthritis, sarcopenic patints with knee ostheoarthritis |
| Dual-X-ray absorptiometryThe 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)]. | Diagnostic test | control group, non sarcopenic patients with knee ostheoarthritis, sarcopenic patints with knee ostheoarthritis |
| Isokinetic dynamometerQuadriceps-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 | Diagnostic test | control group, non sarcopenic patients with knee ostheoarthritis, sarcopenic patints with knee ostheoarthritis |
Primary outcome
Musculoskeletal ultrasonography
Time frame: through study completion, an average of one and a half months
Rectus femoris, Rectus abdominis and gastrocnemius subcutaneosus and muscle thickness measurements will be performed by using ultrasound.
6 secondary outcomes
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: through study completion, an average of one and a half months
Short Form-36 (SF-36)
Time frame: through study completion, an average of one and a half months
The Center for Epidemiologic Studies Depression Scale (CES-D scale)
Time frame: through study completion, an average of one and a half months
The timed 'Up & Go' test
Time frame: through study completion, an average of one and a half months
International Assessment Questionnaire Short Form (IPAQ-SF)
Time frame: through study completion, an average of one and a half months
Mini-Nutritional Assessment (MNA-SF)
Time frame: through study completion, an average of one and a half months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sefa gümrük aslan principal investigator
Gaziler Physical Medicine And Rehabilitation Health Application And Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia and Osteoarthritis, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Musculoskeletal ultrasonography (time frame: through study completion, an average of one and a half months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.