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

Sponsor
Acibadem University (Other)
Overall Status
Completed
CT.gov ID
NCT05015114
Collaborator
(none)
50
1
8.7
5.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Sarcopenia Assessment

Study Design

Study Type:
Observational
Actual Enrollment :
50 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Prevalence and Factors of Sarcopenia in Patients With Primary Sjogren's Syndrome
Actual Study Start Date :
Aug 12, 2021
Actual Primary Completion Date :
May 5, 2022
Actual Study Completion Date :
May 5, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary Outcome Measures

  1. 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.

  2. 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.

  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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 70 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Haydarpasa Numune Research and Training Hospital Istanbul Turkey

Sponsors and Collaborators

  • Acibadem University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Özgül Öztürk, Assistant Professor, Acibadem University
ClinicalTrials.gov Identifier:
NCT05015114
Other Study ID Numbers:
  • ATADEK - 2021/10
First Posted:
Aug 20, 2021
Last Update Posted:
May 25, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 25, 2022