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临床试验/NCT03728231
NCT03728231Unknown不适用

Disease Activity in Rheumatoid Arthritis and Systemic Lupus Erythematosus and Its Relation to Muscle Performance,Fatigue and Blood Parameters

Assiut University0 个研究点目标入组 150 人开始时间: 2018年11月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
主要终点
estimation of muscle performance in Rheumatoid arthritis and Systemic lupus patients by 30_s chair stand test (repetition 4_12) .

研究概览

简要总结

Assessment of disease activity in Rheumatoid Arthritis and Systemic lupus patients related to muscle performance, fatigue and blood parameters

详细描述

Rheumatoid arthritis (RA) is the most common inflammatory arthritis, affecting 0.5-1% of the general population world-wide. It is primarily a disease of the joints, but abnormal systemic immune responses are evident and cause a variety of extra-articular manifestations .

Physical inactivity is one of the key mechanisms affecting skeletal muscle mass and body composition, leading to progressive muscle loss and abdominal fat gain . Muscle strength and endurance are determinants of muscle performance. Relatively little is known about how muscle performance relates to RA clinical variables; also muscle performance is not routinely assessed in clinical practice among patients with RA. Decreased muscle strength has negative outcomes in RA, associating with disease activity, radiological damage and disability .Rheumatoid cachexia, including loss of muscle mass and concomitant increase in fat mass with normal or increased body weight , is a common feature in patients with RA. Assessment of inflammation in RA with markers is important to detect long-term outcome. Parameters of hemogram, particularly those including immune system elements, are important in the assessment of different diseases and/or signs. Immune system elements involve the neutrophils, lymphocytes and platelets that have a role in the control of inflammation, while also undergoing changes secondary to inflammation .

Systemic lupus erythematosus (SLE) is a complex autoimmune disease with chronic relapsing-remitting course and variable manifestations varying from mild mucocutaneous to severe, life-threatening illness .

It has been speculated that fatigue, a symptom frequently observed in approximately 80% of SLE patients , may contribute to a reduction in physical fitness (i.e.,muscle weakness and low cardiovascular capacity) which, in turn, leads to an impairment in the performance of activities of daily living and in the overall quality of life .

SLE patients experienced decreased physical function, low dynamic muscle strength capacity, and poor quality of life, suggesting that either "residual" fatigue or other factors (e.g., long-term medication or systemic inflammation) may have contributed to the poor health-related findings .

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • RA diagnosis according to 1987ACR criteria,or 2010 ACR/EULAR criteria
  • SLE diagnosis according to 1982 ACRor 2012 ACRcriteria
  • Patients aged > 18 years.
  • Stable disease with no activity during last 3 months.
  • Regular medication in last 3 months.

排除标准

  • Subjects with hematologic disorders other than anaemia.
  • Concomitant infectious or inflammatory diseases such as ulcerative colitis.
  • Liver or kidney disease.
  • Coronary heart disease.
  • Other immunological diseases.
  • Pregnant ladies.
  • Patients with end stage organ failure.
  • Patients with malignancies.
  • Patients receiving any medications affect blood picture.

结局指标

主要结局

estimation of muscle performance in Rheumatoid arthritis and Systemic lupus patients by 30_s chair stand test (repetition 4_12) .

时间窗: 6 months

use of 30_s chair stand test(repetition 4_12) in detection of degree of muscle performance in Rheumatoid arthritis and Systemic lupus patients .

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maha Gamal Seddek

Principle Investigator

Assiut University

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