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OpenTrials
Completed

NCT Number: NCT05015114

Prevalence and Factors of Sarcopenia and 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.

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Key information

Conditions

Sarcopenia Arthritis Arthritis, Rheumatoid Atrophy Autoimmune Diseases Collagen Diseases Connective Tissue Diseases Dry Eye Syndromes Eye Diseases Immune System Diseases Joint Diseases Lacrimal Apparatus Diseases Mouth Diseases Muscular Atrophy Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Rheumatic Diseases Rheumatologic Disease Salivary Gland Diseases Signs and Symptoms Sjogren's Syndrome Skin and Connective Tissue Diseases Stomatognathic Diseases Xerostomia

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Haydarpasa Numune Research and Training Hospital

Istanbul, Turkey (Türkiye)

Who can participate

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

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

Treatment and study plan

Sarcopenia Assessment

Other

Sarcopenia Assessment

Primary outcomes

  1. Muscle Mass

    Time frame: 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.

  2. Grip Strength

    Time frame: 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.

  3. Gait Speed

    Time frame: 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.

  4. 5 Times Sit to Stand Test

    Time frame: 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.

Secondary outcomes

  1. EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)

    Time frame: 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.

  2. EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI)

    Time frame: 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.

  3. Malnutrition Evaluation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Acibadem University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 20, 2021
Registry last updated
May 25, 2022

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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