NCT07065448

Brief 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 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 15, 2025

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2025

Completed
Last Updated

July 30, 2025

Status Verified

July 1, 2025

Enrollment Period

4 months

First QC Date

July 3, 2025

Last Update Submit

July 27, 2025

Conditions

Keywords

sarcopeniareliability and validitymuscle strengthupper extremity functionphysical performance parameters

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (3)

  • the 4-meter Gait Speed Test

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

  • the Short Physical Performance Battery (SPPB)

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

  • Timed Up and Go (TUG)

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

Study Arms (2)

Group 1

older adults with sarcopenia

Other: physical performance tests

Group 2

healthy young adults

Other: physical performance tests

Interventions

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.

Group 1Group 2

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Sarcopenia Group and Healthy Young Control Group

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Istanbul, 31180, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 26922142BACKGROUND
  • 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.

    PMID: 27011872BACKGROUND
  • Karacan I, Turker KS. Exploring neuronal mechanisms of osteosarcopenia in older adults. J Physiol. 2024 Aug 9. doi: 10.1113/JP285666. Online ahead of print.

    PMID: 39119811BACKGROUND
  • 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.

    PMID: 30312372BACKGROUND

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • İlhan Karacan, Prof.

    Istanbul Physical Medicine Rehabilitation Training and Research Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

July 3, 2025

First Posted

July 15, 2025

Study Start

April 1, 2025

Primary Completion

July 27, 2025

Study Completion

July 27, 2025

Last Updated

July 30, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations