Clinical trial NCT03728231: Disease Activity in RA and SLE Patients and Its Relation to Muscle Performance,Fatigue and Blood Parameters
Official title: Disease Activity in Rheumatoid Arthritis and Systemic Lupus Erythematosus and Its Relation to Muscle Performance,Fatigue and Blood Parameters
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatic Diseases
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-11-02
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Fifty patients diagnosed Rheumatoid arthritis according to 1987ACR or 2010ACR\\EULAR criteria Fifty patients diagnosed Systemic lupus according to 1982 ACRor 2012ACR criteria Fifty Apperantly healthy persons

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

Detailed description: 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 .

Celikbilek et al. observed that Neutrophil /Lymphocyte Ratio (NLR) and Platelet/Lymphocyte Ratio (PLR) in peripheral blood are simple Systemic Inflammatory Response (SIR) markers which are evaluated by blood parameters and showed that NLR possesses a diagnostic value in certain pathologies characterized by systemic or local inflammatory response. Amaylia et al. found that NLR was significantly higher in SLE than normal subjects .

Eligibility criteria: Inclusion Criteria::

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

Exclusion Criteria:

1. Subjects with hematologic disorders other than anaemia.
2. Concomitant infectious or inflammatory diseases such as ulcerative colitis.
3. Liver or kidney disease.
4. Coronary heart disease.
5. Other immunological diseases.
6. Pregnant ladies.
7. Patients with end stage organ failure.
8. Patients with malignancies.
9. Patients receiving any medications affect blood picture.

Primary outcomes:
measure: estimation of muscle performance in Rheumatoid arthritis and Systemic lupus patients by 30_s chair stand test (repetition 4_12) .
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Biolo G, Cederholm T, Muscaritoli M. Muscle contractile and metabolic dysfunction is a common feature of sarcopenia of aging and chronic diseases: from sarcopenic obesity to cachexia. Clin Nutr. 2014 Oct;33(5):737-48. doi: 10.1016/j.clnu.2014.03.007. Epub 2014 Mar 29.
citation: Hakkinen A, Kautiainen H, Hannonen P, Ylinen J, Makinen H, Sokka T. Muscle strength, pain, and disease activity explain individual subdimensions of the Health Assessment Questionnaire disability index, especially in women with rheumatoid arthritis. Ann Rheum Dis. 2006 Jan;65(1):30-4. doi: 10.1136/ard.2004.034769. Epub 2005 May 18.
citation: Summers GD, Metsios GS, Stavropoulos-Kalinoglou A, Kitas GD. Rheumatoid cachexia and cardiovascular disease. Nat Rev Rheumatol. 2010 Aug;6(8):445-51. doi: 10.1038/nrrheum.2010.105. Epub 2010 Jul 20.
citation: Alaranta H, Hurri H, Heliovaara M, Soukka A, Harju R. Non-dynamometric trunk performance tests: reliability and normative data. Scand J Rehabil Med. 1994 Dec;26(4):211-5.