NCT05015114

Brief Summary

Sarcopenia is a progressive condition characterized by decline in muscle strength and muscle mass. Although the mechanism of sarcopenia has not been fully elucidated, it may be caused by protein-poor diet, vitamin D deficiency, hormonal changes, increase in inflammatory cytokine level and oxidative stress. For this reason, it is thought that determining the prevalence of sarcopenia in rheumatological diseases with chronic inflammation and protecting patients from possible comorbidities with appropriate interventions may be an important factor in maintaining and improving the functional levels and quality of life of patients. The aim of our study was to investigate the prevalence and its associated factors of sarcopenia in individuals with primary Sjögren's Syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2021

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

First Submitted

Initial submission to the registry

August 12, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

August 12, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 20, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2022

Completed
Last Updated

May 25, 2022

Status Verified

May 1, 2022

Enrollment Period

9 months

First QC Date

August 12, 2021

Last Update Submit

May 18, 2022

Conditions

SarcopeniaSjogren's SyndromeRheumatologic Disease

Outcome Measures

Primary Outcomes (4)

  • Muscle Mass

    Muscle mass will be calculated via bioimpedance analysis method. Fat Free Mass will be recorded using TANITA BC 532 Bioimpedance Device and Skeletal Muscle Mass and Skeletal Muscle Mass will be calculated.

    1 day

  • Grip Strength

    Grip strength will be evaluated with JAMAR dynamometer. The patient is positioned in a chair with the elbow flexed to 90 degrees and the wrist in a neutral position, and he/she is asked to grip as strong as he/she can do for 3 seconds. The test is repeated 3 times and the highest value is recorded.

    1 day

  • Gait Speed

    The patient will be asked to walk 4-meters for two times. The shortest time to walk through this distance will be recorded.

    1 day

  • 5 Times Sit to Stand Test

    This test includes the calculation of the time it takes to sit and get up from the chair 5 times while the arms are crossed over the shoulders.

    1 day

Secondary Outcomes (3)

  • EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)

    1 day

  • EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI)

    1 day

  • Malnutrition Evaluation

    1 day

Study Arms (2)

Primary Sjogren's Syndrome

Participants with Primary Sjogren's Syndrome

Other: Sarcopenia Assessment

Control group

Healthy controls

Other: Sarcopenia Assessment

Interventions

Sarcopenia AssessmentOTHER

Sarcopenia Assessment

Control groupPrimary Sjogren's Syndrome

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with primary Sjogren's syndrome

You may qualify if:

  • Diagnosed with primary Sjogren's syndrome by an experienced rheumatologist according to European League Against Rheumatism (EULAR) ve American College of Rheumatology (ACR) criteria
  • Being 40 years or older.

You may not qualify if:

  • Pregnancy,
  • Malignancy,
  • Presence of other rheumatological diseases,
  • Presence of diabetes mellitus
  • Presence of neurological problems
  • Presence of osteoarthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haydarpasa Numune Research and Training Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

SarcopeniaSjogren's SyndromeCollagen Diseases

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsArthritis, RheumatoidArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesXerostomiaSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesDry Eye SyndromesLacrimal Apparatus DiseasesEye DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 12, 2021

First Posted

August 20, 2021

Study Start

August 12, 2021

Primary Completion

May 5, 2022

Study Completion

May 5, 2022

Last Updated

May 25, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)