Presence and Comparison of Sarcopenia in Early Rheumatoid Arthritis and Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Evaluation of Muscle Mass
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Evaluation of Muscle Mass
时间窗: once at the baseline
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.
Evaluation of Muscle Strength
时间窗: once at the baseline
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.
Evaluation of Muscle Performance
时间窗: once at the baseline
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.
次要结局
- Rheumatoid Arthritis Quality of Life Scale(once at the baseline)
- Hospital Anxiety and Depression Scale (HADS)(once at the baseline)
- Health Assessment Questionnaire (HAQ)(once at the baseline)
研究者
Havva Talay Çalış
Prof. Dr
Kayseri City Hospital