SarcopeniaNCT06635356
Knee Replacement and Sarcopenia
An observational study of Sarcopenia and Knee Prosthesis, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The presence of sarcopenia in patients planned to undergo knee prosthesis and the effect of knee prosthesis on sarcopenia will be investigated Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Sarcopenia, Knee Prosthesis, Knee Arthroplasty, Total
- How many people
- 37 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2024to 29 Apr 2025
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Female or male patients between the ages of 50-75 who underwent knee arthroplasty surgery in orthopedic clinics in Istanbul
Who may be able to join
- Being between 50-75 years old
- Undergoing knee arthroplasty surgery
- Patients who agreed to participate in the study and gave written consent
Who cannot join
- Having a history of malignancy
- Being under 50 and over 75 years old
- Having one of the muscle/nerve diseases
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Istanbul, 34192
About this study
Official title: Evaluation of Sarcopenia in Patients Undergoing Knee Prosthesis
The presence of sarcopenia in patients planned to undergo knee prosthesis and the effect of knee prosthesis on sarcopenia will be investigated
Read the detailed description
Volunteer patients who will undergo knee replacement surgery in orthopedic clinics located in the Istanbul region and who meet the inclusion criteria will be recruited. A total of 31 volunteers will be included in the study.
First, all patients will be asked about their gender, age, height, weight, education, smoking, lifestyle, additional diseases, and treatments they have received. Then, a brief orthopedic evaluation will be performed on the patient. TANITA BIA analysis and grip strength measurement from the dominant hand will be performed on all patients before the operation, at 1 month and 3 months after the operation. Maximal voluntary grip strength will be measured with a hand dynamometer. Measurements will be made three times. For this measurement, the subject will be asked to hold a maximal voluntary grip for five seconds. There will be a ten-second rest period between the three tests. Measurements will be made with the JAMAR Plus+ (by Sammons Preston) hand dynamometry device. Before the test measurements, the patient will be shown how to use the device as an application. The highest of the three measured values will be taken. In addition, the calf circumference will be measured. While the patient is standing, the measurement will be made with a tape measure from the thickest point of the right and left calves without squeezing the skin. The same measurement will be repeated with the patient seated. At the same time, patients will be evaluated with walking speed test, sit-to-stand test, SARC-F, FRAIL Frailty Questionnaire, Mini Nutritional Assessment, EQ-5D General Quality of Life Scale, GLIM Test, Barthel Activities of Daily Living Index, CIRS Scale before the operation, 1st month and 3rd month after the operation.
When performing the walking speed test, the patient will be asked to walk as they normally do. A 4-meter or 3-meter walking speed test will be performed and a single test will be scored. Measurements will be made twice and the fastest will be evaluated.
In the sit-to-stand test, the person will be asked to try to get up without using their arms. If they cannot complete the test or can get up using their arms, the patient will receive 0 (zero) points. If they can get up using their arms, the repeated sit-to-stand test will be performed. In the repeated sit-to-stand test, the person will be asked to sit down and get up from a chair 5 times in a row without using their arms. Scoring will be between 0-4 depending on the time spent.
- Conditions
- Sarcopenia, Knee Prosthesis, Knee Arthroplasty, Total
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| The frequency and change of sarcopenia in patients undergoing knee arthroplasty | Sarcopenia frequency and changes will be investigated in women and men between the ages of 50 and 75 who will undergo knee prosthesis surgery, with follow-ups to be performed before the operation, in the first month and in the third month after the operation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calf circumference measurement
Calf circumference is an anthropometric measurement that indicates fatfree muscle mass and has been considered by the World Health Organization (WHO) the most sensitive index for evaluating the decrease in muscle mass.
While the patient is standing, the measurement will be taken with a tape measure from the thickest point of the right and left calves without squeezing the skin.
Measured: before surgery, 1st month after surgery, 3rd month after surgery
Handgrip strength
Handgrip strength will be measured using a Jamar hand grip dynamometer (Model 5030J1, Sammons Preston Rolyan, Bolingbrook, Illinois, USA). Measurements will be taken 3 times in a sitting position with the elbow flexed to 90° and the wrist in neutral position. The measured maximal grip strength will be recorded as hand grip strength.
Measured: before surgery, 1st month after surgery, 3rd month after surgery
Skeletal muscle mass
Skeletal muscle mass will be evaluated using a Tanita DC-360 multi-frequency body composition analysis device.
Measured: before surgery, 1st month after surgery, 3rd month after surgery
Body Mass Index (BMI)
BMI will be calculated as weight (kg) divided by height2 (m2)
Measured: before surgery, 1st month after surgery, 3rd month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start1 Oct 2024
- Primary completion29 Apr 2025
- Study completion29 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Nida Lale, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635356
- Sponsor's protocol ID
- IstanbulPMRTRH-kneerepsarc
- Status last verified
- Oct 2024
- First submitted
- 8 Oct 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tanaka S, Kayamoto A, Terai C, Nojiri S, Fugane Y, Mori T, Nagaya M, Kako M, Iida H, Osawa Y, Takegami Y, Nishida Y. Preoperative Sarcopenia Severity and Clinical Outcomes after Total Hip Arthroplasty. Nutrients. 2024 Jun 29;16(13):2085. doi: 10.3390/nu16132085.
PubMed 38999833Tzartza CL, Karapalis N, Voulgaridou G, Zidrou C, Beletsiotis A, Chatziprodromidou IP, Giaginis C, Papadopoulou SK. Comparative Analysis on the Effect of Sarcopenia in Patients with Knee Osteoarthritis before and after Total Knee Arthroplasty. Diseases. 2023 Feb 22;11(1):36. doi: 10.3390/diseases11010036.
PubMed 36975585Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
PubMed 30312372
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Sarcopenia in Patients Undergoing Knee Prosthesis
- ClinicalTrials.gov ID
- NCT06635356
- Acronym / sponsor ID
- IstanbulPMRTRH-kneerepsarc
- Conditions
- Sarcopenia, Knee Prosthesis, Knee Arthroplasty, Total
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 29 Apr 2025 (actual)
- Study completion
- 29 Apr 2025 (actual)
- First posted
- 10 Oct 2024 (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.
The presence of sarcopenia in patients planned to undergo knee prosthesis and the effect of knee prosthesis on sarcopenia will be investigated
Detailed description
Volunteer patients who will undergo knee replacement surgery in orthopedic clinics located in the Istanbul region and who meet the inclusion criteria will be recruited. A total of 31 volunteers will be included in the study.
First, all patients will be asked about their gender, age, height, weight, education, smoking, lifestyle, additional diseases, and treatments they have received. Then, a brief orthopedic evaluation will be performed on the patient. TANITA BIA analysis and grip strength measurement from the dominant hand will be performed on all patients before the operation, at 1 month and 3 months after the operation. Maximal voluntary grip strength will be measured with a hand dynamometer. Measurements will be made three times. For this measurement, the subject will be asked to hold a maximal voluntary grip for five seconds. There will be a ten-second rest period between the three tests. Measurements will be made with the JAMAR Plus+ (by Sammons Preston) hand dynamometry device. Before the test measurements, the patient will be shown how to use the device as an application. The highest of the three measured values will be taken. In addition, the calf circumference will be measured. While the patient is standing, the measurement will be made with a tape measure from the thickest point of the right and left calves without squeezing the skin. The same measurement will be repeated with the patient seated. At the same time, patients will be evaluated with walking speed test, sit-to-stand test, SARC-F, FRAIL Frailty Questionnaire, Mini Nutritional Assessment, EQ-5D General Quality of Life Scale, GLIM Test, Barthel Activities of Daily Living Index, CIRS Scale before the operation, 1st month and 3rd month after the operation.
When performing the walking speed test, the patient will be asked to walk as they normally do. A 4-meter or 3-meter walking speed test will be performed and a single test will be scored. Measurements will be made twice and the fastest will be evaluated.
In the sit-to-stand test, the person will be asked to try to get up without using their arms. If they cannot complete the test or can get up using their arms, the patient will receive 0 (zero) points. If they can get up using their arms, the repeated sit-to-stand test will be performed. In the repeated sit-to-stand test, the person will be asked to sit down and get up from a chair 5 times in a row without using their arms. Scoring will be between 0-4 depending on the time spent.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The frequency and change of sarcopenia in patients undergoing knee arthroplasty | – | –Sarcopenia frequency and changes will be investigated in women and men between the ages of 50 and 75 who will undergo knee prosthesis surgery, with follow-ups to be performed before the operation, in the first month and in the third month after the operation. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female or male patients between the ages of 50-75 who underwent knee arthroplasty surgery in orthopedic clinics in Istanbul
Key inclusion criteria (3 listed)
- Being between 50-75 years old
- Undergoing knee arthroplasty surgery
- Patients who agreed to participate in the study and gave written consent
Key exclusion criteria (3 listed)
- Having a history of malignancy
- Being under 50 and over 75 years old
- Having one of the muscle/nerve diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Calf circumference measurement
Time frame: before surgery, 1st month after surgery, 3rd month after surgery
Calf circumference is an anthropometric measurement that indicates fatfree muscle mass and has been considered by the World Health Organization (WHO) the most sensitive index for evaluating the decrease in muscle mass. While the patient is standing, the measurement will be taken with a tape measure from the thickest point of the right and left calves without squeezing the skin.
Handgrip strength
Time frame: before surgery, 1st month after surgery, 3rd month after surgery
Handgrip strength will be measured using a Jamar hand grip dynamometer (Model 5030J1, Sammons Preston Rolyan, Bolingbrook, Illinois, USA). Measurements will be taken 3 times in a sitting position with the elbow flexed to 90° and the wrist in neutral position. The measured maximal grip strength will be recorded as hand grip strength.
Skeletal muscle mass
Time frame: before surgery, 1st month after surgery, 3rd month after surgery
Skeletal muscle mass will be evaluated using a Tanita DC-360 multi-frequency body composition analysis device.
Body Mass Index (BMI)
Time frame: before surgery, 1st month after surgery, 3rd month after surgery
BMI will be calculated as weight (kg) divided by height2 (m2)
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 27 Mar 2026.
- Background: PubMed 38999833Tanaka S, Kayamoto A, Terai C, Nojiri S, Fugane Y, Mori T, Nagaya M, Kako M, Iida H, Osawa Y, Takegami Y, Nishida Y. Preoperative Sarcopenia Severity and Clinical Outcomes after Total Hip Arthroplasty. Nutrients. 2024 Jun 29;16(13):2085. doi: 10.3390/nu16132085.
- Background: PubMed 36975585Tzartza CL, Karapalis N, Voulgaridou G, Zidrou C, Beletsiotis A, Chatziprodromidou IP, Giaginis C, Papadopoulou SK. Comparative Analysis on the Effect of Sarcopenia in Patients with Knee Osteoarthritis before and after Total Knee Arthroplasty. Diseases. 2023 Feb 22;11(1):36. doi: 10.3390/diseases11010036.
- Background: PubMed 30312372Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Knee Prosthesis, run by Istanbul Physical Medicine Rehabilitation Training 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 3 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 27 Mar 2026. 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?
Calf circumference measurement (time frame: before surgery, 1st month after surgery, 3rd month after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06635356, which also lists 3 linked publications.
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 27 Mar 2026.