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

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05015114
• Other study ID #: ATADEK - 2021/10
• Status: Completed
• Start date: August 12, 2021
• Est. completion date: May 5, 2022

Study information

• Verified date: May 2022
• Source: Acibadem University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 5, 2022
• Est. primary completion date: May 5, 2022
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Collagen Diseases
• Rheumatic Diseases
• Rheumatologic Disease
• Sarcopenia
• Sjogren's Syndrome
• Syndrome

Intervention

Other:
• Sarcopenia Assessment
Sarcopenia Assessment

Locations

Country	Name	City	State
Turkey	Haydarpasa Numune Research and Training Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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