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Investigation of Possible Sarcopenia and/or the Presence of Sarcopenia in Patients With Primary Sjögren's Syndrome and Its Effect on Functional Status

Investigation of Possible Sarcopenia and/or the Presence of Sarcopenia in Patients With Primary Sjögren's Syndrome and Its Effect on Functional Status

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07804719
Enrollment
120
Registered
2026-09-04
Start date
2025-07-20
Completion date
2026-09-20
Last updated
2026-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Sjögren Syndrome, Sarcopenia

Keywords

primary sjogren syndrome, Sarcopenia, muscle mass, hand grip strength, physical performance, functional status

Brief summary

The aim of this study is to evaluate the frequency of probable sarcopenia and sarcopenia in patients with primary Sjögren syndrome and to investigate the effects of sarcopenia on functional status, muscle strength, and quality of life. Adult patients diagnosed with primary Sjögren syndrome will be included in the study. Muscle strength, muscle mass, physical performance, and functional status will be assessed using various evaluation methods

Detailed description

Primary Sjögren syndrome is a chronic autoimmune inflammatory disease that may affect the musculoskeletal system. Sarcopenia is characterized by decreased muscle mass and muscle strength and may lead to impaired physical performance and functional capacity. In this cross-sectional study, the presence of probable sarcopenia and sarcopenia in adult patients with primary Sjögren syndrome will be evaluated. Demographic characteristics, disease duration, and clinical findings of the participants will be recorded. Muscle strength will be assessed using handgrip strength testing, and physical performance will be evaluated using functional performance tests. In addition functional status scales will be administered. The study aims to determine the effects of sarcopenia on functional status and quality of life in patients with primary Sjögren syndrome.

Interventions

DIAGNOSTIC_TESTdexa, hand grip strength, myostatin, follistatin

Although these parameters are frequently assessed in other rheumatological diseases, few studies have previously examined such a wide range of parameters in patients with primary Sjögren's syndrome.

Sponsors

Antalya Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

1. Voluntarily 2. Women over the age of 18 3. Women diagnosed with primary Sjögren's syndrome

Exclusion criteria

1. Those with cognitive impairment 2. Pregnancy 3. Malignancy 4. Those with other rheumatic diseases 5. Uncontrolled chronic disease(diabetes mellitus, hypertension, hypothyroidism, hyperthyroidism) 6. Those who have difficulty walking on their own 7. Arthritis present in the dominant hand joints 8. Central and peripheral nervous system findings 9. Myositis and mechanical pain 10. Individuals receiving treatment for hyperlipidemia

Design outcomes

Primary

MeasureTime frameDescription
muscle strength12 monthMuscle strength will be assessed using hand-held dynamometry. Measurements will be recorded in kilograms-force (kgf) and compared between primary Sjögren syndrome patients and healthy controls.
muscle mass12 monthsMuscle mass will be assessed using DEXA. Results will be compared between groups.
functional status12 monthsFunctional status will be evaluated using validated functional assessment scales. Scores will be compared between primary Sjögren syndrome patients and healthy controls.

Secondary

MeasureTime frameDescription
myostatin12 monthsSerum myostatin levels will be measured using enzyme-linked immunosorbent assay (ELISA) and compared between groups.
follistatin12 monthsSerum follistatin levels will be measured using enzyme-linked immunosorbent assay (ELISA) and compared between groups.

Countries

Turkey (Türkiye)

Contacts

STUDY_DIRECTORMehmet Çetin, research asistant

Antalya Training and Research Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 5, 2026