Presence and Comparison of Sarcopenia in Early Rheumatoid Arthritis and Rheumatoid Arthritis

NCT06284200 | Recruiting

• 1 other identifier: sarcopenia eRA
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

introduction: In this study, the presence of sarcopenia in cases with early rheumatoid arthritis and established rheumatoid arthritis will be compared. Materials and Method: According to the power analysis, 24 patients with early rheumatoid arthritis and 24 patients with established rheumatoid arthritis who meet the 2010 American College of Rheumatology (ACR) / European Alliance of Associations for Rheumatology (EULAR) rheumatoid arthritis (RA) classification criteria will be included in the study.

Conditions

Sarcopenia

Keywords

Early Rheumatoid Arthritis; Sarcopenia; Rheumatoid Arthritis; Appendicular Skeletal Muscle Mass Index

Outcome Measures

Primary Outcomes (3)

• Evaluation of Muscle Mass

  Muscle mass evaluations in patients will be made using the Bioelectrical Impedance Analysis (BIA) (Multi Frequency Segmental Body Composition) method. According to the data obtained from the BIA device, appendicular skeletal muscle mass index (ASMI). The ASMI cut-off point recommended by the EuropeanWorkingGroup on Sarcopenia in Older People (EWGSOP2) would be \<7.26 kg/m2 for men and \<5.5 kg/m2 for women. Patients with low ASMI will be evaluated as having sarcopenia.

  once at the baseline

• Evaluation of Muscle Strength

  In general, hand grip strength is one of two methods used to measure muscle strength in patients with suspected sarcopenia. Hand grip strength is related to strength in other muscles and can therefore be used as a tool to demonstrate muscle weakness. The hydraulic hand dynamometer will be used in all patients included in this study, and measurements will be recorded in kilogram. Measurements will be made with the patient in a sitting position on a chair, with the elbow close to the body and 90 degrees of flexion, and the wrist in neutral.Patients will be asked to grasp the dynamometer as firmly as possible. Three measurements will be taken for the patients and the average was taken. The recommended cut-off point for the hand grip test will be considered to be \<27 kg for men and \<16 kg for women.Patients with low hand grip strength will be evaluated as having possible sarcopenia.

  once at the baseline

• Evaluation of Muscle Performance

  Physical performance will be evaluated with a 4-meter general walking speed test. The patient will be asked to walk a distance of 4 meters at his normal pace, as in his daily life, and the time to walk the distance of 4 meters will be calculated in seconds. 4 meter general walking speed will be calculated in m/sec and speeds below 0.8 m/sec will be considered low walking speed.

  once at the baseline

Secondary Outcomes (3)

• Rheumatoid Arthritis Quality of Life Scale

  once at the baseline

• Health Assessment Questionnaire (HAQ)

  once at the baseline

• Hospital Anxiety and Depression Scale (HADS)

  once at the baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In the planned single-center study, patients with clinically confirmed RA and early RA diagnosed who applied to Kayseri City Hospital Physical Medicine and Rehabilitation outpatient clinic will be included in the study after their consent is obtained.

You may qualify if:

• To be diagnosed with RA according to the 2010 ACR (American Society for the Study of Rheumatism) / EULAR (European Association for the Study of Rheumatism) RA classification criteria
• Being 18 years or older
• Being followed up with a diagnosis of RA for less than 1 year (early RA)
• To be diagnosed with RA according to the 2010 ACR (American Society for the Study of Rheumatism) / EULAR (European Association for the Study of Rheumatism) RA classification criteria
• Being 18 years or older

You may not qualify if:

• Presence of other rheumatic disease
• Presence of malnutrition
• Recent surgical history,
• Stroke history,
• Pregnancy,
• Presence of prosthesis or metal implant,
• Presence of a pacemaker,
• Patients over 140 kg

Sponsors & Collaborators

• Kayseri City Hospital: lead

Study Sites (1)

Health Sciences University, Kayseri Medicine Faculty

Kocasinan, Kayseri, 38125, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Sarcopenia; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• HAVVA TALAY ÇALIŞ, PROF

  Health Sciences University, Kayseri Medical Faculty

  STUDY DIRECTOR

Central Study Contacts

HAVVA TALAY ÇALIŞ, PROF

CONTACT

+905326874541; htalaycalis@yahoo.com

MEHMET KÖKSAL, MD

CONTACT

+905514043114; dr.mhmtkksl@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: February 28, 2024
• Study Start: June 23, 2023
• Primary Completion: March 23, 2024
• Study Completion: June 23, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

TU (1)