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临床试验/NCT07804719
NCT07804719进行中(未招募)不适用

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

Antalya Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年7月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
120
试验地点
1
主要终点
muscle strength

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • Those with cognitive impairment
  • 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

研究组 & 干预措施

primary sjögren syndrome group

Participants' muscle strength, muscle mass, and physical performance were examined.

干预措施: dexa, hand grip strength, myostatin, follistatin (Diagnostic Test)

Control group

Participants' muscle strength, muscle mass, and physical performance were examined.

干预措施: dexa, hand grip strength, myostatin, follistatin (Diagnostic Test)

结局指标

主要结局

muscle strength

时间窗: 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.

muscle mass

时间窗: 12 months

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

functional status

时间窗: 12 months

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

次要结局

  • myostatin(12 months)
  • follistatin(12 months)

研究者

发起方
Antalya Training and Research Hospital
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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