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SarcopeniaNCT07065448

Alternative to Gait Speed in Sarcopenia Assessment

An observational study of Sarcopenia and Elderly, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to assess the reliability of the Elbow Performance Test as an upper extremity-based alternative for evaluating sarcopenia severity. Unlike traditional lower extremity-focused assessments, this test may offer a practical solution for individuals with mobility limitations or comorbidities affecting the… Read more about this study

Who is it for?
Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
Sarcopenia, Elderly
What is being tested?
physical performance tests
How many people
96 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Apr 2025to 27 Jul 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 18 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Sarcopenia Group and Healthy Young Control Group

Who may be able to join

  • Individuals who consent to participate in the study
  • Sarcopenia Group
  • Male participants aged 60 years or older
  • Diagnosed with sarcopenia according to EWGSOP2 criteria
  • Healthy Young Control Group
  • Male participants aged 40 years or younger
  • SARC-F screening test score < 4

Who cannot join

  • Inability to cooperate
  • Poor general condition due to acute medical problems
  • Chronic decompensated cardiac, renal, or hepatic failure
  • Presence of rheumatologic, psychiatric, or neurological disorders
  • Use of performance-enhancing or fatigue-reducing medications

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Istanbul Physical Medicine Rehabilitation Training and Research Hospital

    Istanbul, 31180

Other trials in Turkey (Türkiye)

About this study

Official title: The Reliability of the Elbow Isotonic Contraction Test as an Alternative to the Gait Speed Test in Assessing Sarcopenia Severity

This study aims to assess the reliability of the Elbow Performance Test as an upper extremity-based alternative for evaluating sarcopenia severity. Unlike traditional lower extremity-focused assessments, this test may offer a practical solution for individuals with mobility limitations or comorbidities affecting the lower limbs. Participants will include older adults with sarcopenia and healthy young adults. Functional tests, including the 4-meter Gait Speed Test, SPPB, TUG, and the Elbow Performance Test, will be administered twice within a 7-10-day interval. Reliability will be analyzed using intraclass correlation coefficients (ICC).

Read the detailed description

Background:Sarcopenia is a generalized and progressive skeletal muscle disorder characterized by a decline in muscle strength, mass, and function. The severity of sarcopenia is commonly assessed using functional performance tests, which are also used for monitoring disease progression and treatment response. However, lower extremity-based tests may have limited applicability in the presence of various comorbidities.

Objective: This study proposes an upper extremity-based alternative, the Elbow Performance Test, and aims to evaluate its reliability in comparison to the commonly used 4-meter Gait Speed Test.

Method:This planned cross-sectional study will include two groups: older adults with sarcopenia and healthy young adults. All participants will undergo the 4-meter Gait Speed Test, the Short Physical Performance Battery (SPPB), the Timed Up and Go (TUG) test, and the Elbow Performance Test on two separate occasions, with a 7-10-day interval between sessions. In the Elbow Performance Test, a 1-kilogram sandbag will be attached to the distal forearm of the dominant arm, and participants will be instructed to perform 30 consecutive elbow flexion-extension movements. The total time required to complete the repetitions will be recorded. The reliability of the test will be evaluated using intraclass correlation coefficients (ICC).

Conditions
Sarcopenia, Elderly
Being tested
physical performance tests
Keywords
sarcopenia, reliability and validity, muscle strength, upper extremity function, physical performance parameters
Medical subject headings
Sarcopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • physical performance testsOther

    All participants underwent the 4-meter Gait Speed Test, the Short Physical Performance Battery (SPPB), the Timed Up and Go (TUG) test, and the Elbow Performance Test twice, with a 7-10-day interval between sessions. In the Elbow Performance Test, a 1-kilogram sandbag was fixed to the distal forearm of the dominant arm, and participants were asked to perform 30 consecutive elbow flexion-extension movements.

Study groups in NCT07065448
Study groupRoleWhat they receive
Group 1older adults with sarcopenia
Receives: Other: physical performance tests
Group 2healthy young adults
Receives: Other: physical performance tests

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the Elbow Performance Test

    The total time required to complete thirty consecutive elbow flexion-extension movements, performed with a one-kilogram sandbag attached to the distal forearm of the dominant arm.

    Measured: Two assessment sessions conducted seven to ten days apart to evaluate test-retest reliability using intraclass correlation coefficients (ICC).

Secondary outcomes (3)

  1. the 4-meter Gait Speed Test

    The 4-Meter Gait Speed Test was used to evaluate functional mobility. Participants walked a total of 6 meters at their usual pace, with timing recorded only for the central 4-meter section. A stopwatch was used to measure the time, and gait speed was calculated in meters per second.

    Measured: Two assessment sessions conducted seven to ten days apart to evaluate test-retest reliability using intraclass correlation coefficients (ICC).

  2. the Short Physical Performance Battery (SPPB)

    Physical performance will be assessed using the Short Physical Performance Battery (SPPB), which includes balance tests (standing positions), the 4-meter gait speed test, and the five-times sit-to-stand test. Each component is scored from 0 to 4, yielding a total score ranging from 0 to 12, with higher scores indicating better physical function.

    Measured: Two assessment sessions conducted seven to ten days apart to evaluate test-retest reliability using intraclass correlation coefficients (ICC).

  3. Timed Up and Go (TUG)

    Functional mobility and balance will be assessed using the Timed Up and Go (TUG) test, which measures the time required to stand up from a chair, walk three meters, turn around, and sit back down.

    Measured: Two assessment sessions conducted seven to ten days apart to evaluate test-retest reliability using intraclass correlation coefficients (ICC).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2025
  2. Study start1 Apr 2025
  3. Primary completion27 Jul 2025
  4. Study completion27 Jul 2025

Resources

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
Cross-sectional
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07065448
Sponsor's protocol ID
IstPRMTRH-TYY1
Status last verified
Jul 2025
First submitted
3 Jul 2025
Last updated
30 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bahat G, Tufan A, Tufan F, Kilic C, Akpinar TS, Kose M, Erten N, Karan MA, Cruz-Jentoft AJ. Cut-off points to identify sarcopenia according to European Working Group on Sarcopenia in Older People (EWGSOP) definition. Clin Nutr. 2016 Dec;35(6):1557-1563. doi: 10.1016/j.clnu.2016.02.002. Epub 2016 Feb 11.

    PubMed 26922142

  • Power GA, Dalton BH, Rice CL. Human neuromuscular structure and function in old age: A brief review. J Sport Health Sci. 2013 Dec;2(4):215-226. doi: 10.1016/j.jshs.2013.07.001.

    PubMed 27011872

  • Karacan I, Turker KS. Exploring neuronal mechanisms of osteosarcopenia in older adults. J Physiol. 2026 Jan;604(2):672-688. doi: 10.1113/JP285666. Epub 2024 Aug 9.

    PubMed 39119811

  • Cruz-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

  • Yildirim TY, Kalaoglu E, Aydin T, Turker KS, Karacan I. A novel upper-extremity-based performance test for sarcopenia: reliability and clinical utility of the elbow performance test. Ir J Med Sci. 2026 Feb;195(1):213-219. doi: 10.1007/s11845-025-04263-1. Epub 2026 Jan 7.

    PubMed 41499000

Questions about this trial

What is this clinical trial studying?

An observational study of Sarcopenia and Elderly, 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 7 inclusion and 5 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 30 Jul 2025. 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?

the Elbow Performance Test (time frame: Two assessment sessions conducted seven to ten days apart to evaluate test-retest reliability using intraclass correlation coefficients (ICC).). 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 NCT07065448, which also lists 5 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 30 Jul 2025.

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