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

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

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.

Study Overview

• Status: Completed
• Conditions: Sarcopenia; Sjogren's Syndrome; Rheumatologic Disease
• Intervention / Treatment: Other: Sarcopenia Assessment

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Haydarpasa Numune Research and Training Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with primary Sjogren's syndrome

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Primary Sjogren's Syndrome; Participants with Primary Sjogren's Syndrome	Other: Sarcopenia Assessment; Sarcopenia Assessment
Control group; Healthy controls	Other: Sarcopenia Assessment; Sarcopenia Assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)	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.	1 day
EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI)	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.	1 day
Malnutrition Evaluation	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.	1 day

Collaborators and Investigators

• Sponsor: Acibadem University

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2021
• Primary Completion (Actual): May 5, 2022
• Study Completion (Actual): May 5, 2022

Study Registration Dates

• First Submitted: August 12, 2021
• First Submitted That Met QC Criteria: August 19, 2021
• First Posted (Actual): August 20, 2021

Study Record Updates

• Last Update Posted (Actual): May 25, 2022
• Last Update Submitted That Met QC Criteria: May 18, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Autoimmune Diseases; Eye Diseases; Neurologic Manifestations; Disease; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Mouth Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Lacrimal Apparatus Diseases; Muscular Atrophy; Atrophy; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Syndrome; Sarcopenia; Rheumatic Diseases; Collagen Diseases; Sjogren's Syndrome
• Other Study ID Numbers: ATADEK - 2021/10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No