Clinical trial NCT06284200: Presence and Comparison of Sarcopenia in Early Rheumatoid Arthritis and Rheumatoid Arthritis
Official title: Presence and Comparison of Sarcopenia in Early Rheumatoid Arthritis and Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sarcopenia
Keywords: Early Rheumatoid Arthritis
Sarcopenia
Rheumatoid Arthritis
Appendicular Skeletal Muscle Mass Index
Lead sponsor: Kayseri City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-02-28
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

Detailed description: According to the power analysis, 24 patients with early rheumatoid arthritis and 24 patients with established rheumatoid arthritis who met the 2010 ACR / EULAR RA classification criteria will be included in the study. The presence of sarcopenia will be evaluated according to the European Working Group on Sarcopenia in Older People (EWGSOP-2) criteria by performing hand grip strength, muscle mass measurement with Bioelectrical Impedance Analysis (BIA), and 4-meter general walking speed tests. Demographic data of the patients and anti-nuclear antibody (ANA), rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) levels, Simplified Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI), Disease Activity Score ( DAS)28, functional status (health assessment questionnaire (HAQ)), quality of life (RA quality of life scale (RAQoL)), anxiety and depression (hospital anxiety and depression scale (HADS)) results will be evaluated.

Eligibility criteria: Inclusion Criteria:

Inclusion criteria for the early RA group:

* 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)

Inclusion criteria for the RA group:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Evaluation of Muscle Mass
timeFrame: once at the baseline
measure: Evaluation of Muscle Strength
timeFrame: once at the baseline
measure: Evaluation of Muscle Performance
timeFrame: once at the baseline
Secondary outcomes:
measure: Rheumatoid Arthritis Quality of Life Scale
timeFrame: once at the baseline
measure: Health Assessment Questionnaire (HAQ)
timeFrame: once at the baseline
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: once at the baseline
Other outcomes:
Locations:
city: Kocasinan
country: Turkey
facility: Health Sciences University, Kayseri Medicine Faculty
state: Kayseri
Study officials:
affiliation: Health Sciences University, Kayseri Medical Faculty
name: HAVVA TALAY ÇALIŞ, PROF
role: STUDY_DIRECTOR
References: