NCT04828200

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2016

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2016

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
Last Updated

April 8, 2021

Status Verified

April 1, 2021

Enrollment Period

5 months

First QC Date

March 28, 2021

Last Update Submit

April 5, 2021

Conditions

SarcopeniaOsteoarthritis

Keywords

Dual-X-ray absorptiometrySarcopeniaKnee osteoarthritisultrasonography

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • The Western Ontario and McMaster Universities Arthritis Index (WOMAC)

    through study completion, an average of one and a half months

  • Short Form-36 (SF-36)

    through study completion, an average of one and a half months

  • The Center for Epidemiologic Studies Depression Scale (CES-D scale)

    through study completion, an average of one and a half months

  • The timed 'Up & Go' test

    through study completion, an average of one and a half months

  • International Assessment Questionnaire Short Form (IPAQ-SF)

    through study completion, an average of one and a half months

  • +1 more secondary outcomes

Study Arms (3)

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.

Diagnostic Test: Musculoskeletal ultrasoundDiagnostic Test: Dual-X-ray absorptiometryDiagnostic 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.

Diagnostic Test: Musculoskeletal ultrasoundDiagnostic Test: Dual-X-ray absorptiometryDiagnostic 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

Diagnostic Test: Musculoskeletal ultrasoundDiagnostic Test: Dual-X-ray absorptiometryDiagnostic Test: Isokinetic dynamometer

Interventions

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°.

control groupnon sarcopenic patients with knee ostheoarthritissarcopenic patints with knee ostheoarthritis
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 \[SMI = ASM / height2 (kg / m2)\].

control groupnon sarcopenic patients with knee ostheoarthritissarcopenic patints with knee ostheoarthritis
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

control groupnon sarcopenic patients with knee ostheoarthritissarcopenic patints with knee ostheoarthritis

Eligibility Criteria

Age50 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziler PMR, Training and Research Hospital, Department of PMR

Ankara, Çankaya/turkey, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

SarcopeniaOsteoarthritisOsteoarthritis, Knee

Interventions

Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDensitometryPhotometryChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Sefa gümrük aslan

    Gaziler Physical Medicine And Rehabilitation Health Application And Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical Medicine and Rehabilitation Specialist

Study Record Dates

First Submitted

March 28, 2021

First Posted

April 1, 2021

Study Start

April 10, 2016

Primary Completion

September 10, 2016

Study Completion

September 10, 2016

Last Updated

April 8, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)