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Active, not recruiting

NCT Number: NCT07804719

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

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

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Primary Sjögren Syndrome Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Antalya Training and Research Hospital

Antalya, 07100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Voluntarily
  • Women over the age of 18
  • Women diagnosed with primary Sjögren's syndrome

Exclusion criteria

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

Treatment and study plan

dexa, hand grip strength, myostatin, follistatin

Diagnostic Test

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.

Primary outcomes

  1. muscle strength

    Time frame: 12 month

    Muscle 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.

  2. muscle mass

    Time frame: 12 months

    Muscle mass will be assessed using DEXA. Results will be compared between groups.

  3. functional status

    Time frame: 12 months

    Functional status will be evaluated using validated functional assessment scales. Scores will be compared between primary Sjögren syndrome patients and healthy controls.

Secondary outcomes

  1. myostatin

    Time frame: 12 months

    Serum myostatin levels will be measured using enzyme-linked immunosorbent assay (ELISA) and compared between groups.

  2. follistatin

    Time frame: 12 months

    Serum follistatin levels will be measured using enzyme-linked immunosorbent assay (ELISA) and compared between groups.

Sponsors and collaborators

Lead sponsor

Antalya Training and Research Hospital

Other Gov

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Sep 4, 2026
Registry last updated
Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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