Prevalence and Factors of Sarcopenia and in Patients With Primary Sjogren's Syndrome

Completed

• Conditions: Sjogren's Syndrome; Rheumatologic Disease; Sarcopenia
• Interventions: Other: Sarcopenia Assessment

• Registration Number: NCT05015114
• Lead Sponsor: Acibadem University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-12
• Study First Submitted: 2021-08-12
• Study First Submitted QC: 2021-08-19
• Study First Posted: 2021-08-20
• Status Verified: 2022-05
• Primary Completion: 2022-05-05
• Study Completion: 2022-05-05
• Last Update Submitted: 2022-05-18
• Last Update Posted: 2022-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 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.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	Sarcopenia Assessment	Healthy controls
Primary Sjogren's Syndrome	Sarcopenia Assessment	Participants with Primary Sjogren's Syndrome

Primary Outcome Measures

Name	Time	Method
Grip Strength	1 day	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.
Gait Speed	1 day	The patient will be asked to walk 4-meters for two times. The shortest time to walk through this distance will be recorded.
5 Times Sit to Stand Test	1 day	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.
Muscle Mass	1 day	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.

Secondary Outcome Measures

Name	Time	Method
EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI)	1 day	The patient is asked to define the level of fatigue, pain and dryness symptoms with a score between 1 and 10, and the average of the score obtained from these three questions are recorded. An ESSPRI score of less than 5 was considered an acceptable disease state, while a score of 5 or above was considered a sign of high activity.
EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)	1 day	ESSDAI was developed to determine the disease activity level specifically for Sjogren's Syndrome. It includes 12 domains (ie, organ systems: cutaneous, respiratory, renal, articular, muscular, peripheral nervous system (PNS), central nervous system (CNS), haematological, glandular, constitutional, lymphadenopathic, biological). Each domain is divided into 3-4 levels of activity. A score less than 5 indicates a low level of disease, a score between 5 and 13 indicates a moderate level, and a score of more than 14 indicates a high level of active 14. It is a scoring system that evaluates every domain between 0 and 3.
Malnutrition Evaluation	1 day	The presence of malnutrition in the participants will be evaluated with the Mini Nutritional Assessment Form (Short Form). This form consists of 6 questions including loss of appetite, weight loss, mobility, stress or acute illness, dementia or depression, and body mass index. The total score ranges from 0 to 14, with 12 and above meaning "normal nutritional status", 8 to 11 "malnutrition risk" and 0 to 7 meaning malnutrition.

Trial Locations

Locations (1)

Haydarpasa Numune Research and Training Hospital; 🇹🇷 Istanbul, Turkey