Disease Activity in RA and SLE Patients and Its Relation to Muscle Performance,Fatigue and Blood Parameters

• Conditions: Rheumatic Diseases
• Interventions: Other: Complete blood count

• Registration Number: NCT03728231
• Lead Sponsor: Assiut University

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 .

Study Timeline

• Status Verified: 2018-10
• Study First Submitted: 2018-10-24
• Study First Submitted QC: 2018-10-31
• Last Update Submitted: 2018-10-31
• Study First Posted: 2018-11-02
• Last Update Posted: 2018-11-02
• Study Start: 2018-11-15
• Primary Completion: 2019-11-11
• Study Completion: 2020-02-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fifty patients with RA.	Complete blood count	-CBC with assessment of NLR and PLR. Immumological tests (RF, ANA, anti-ds DNA). * Functional Performance Tests:(12) * Fatigue severity scale (13). * Short-Form Health Survey 36 (SF-36) (14). * the short version of the International Physical activity Questionnaire (s-IPAQ) (15). * frequency intensity time (FIT) index of kasari (16). :\* Disease activity Score(DAS)(17)
Fifty patients with SLE.	Complete blood count	CBC with assessment of NLR and PLR. Immumological tests (RF, ANA, anti-ds DNA). * Functional Performance Tests:(12) * Fatigue severity scale (13). * Short-Form Health Survey 36 (SF-36) (14). * the short version of the International Physical activity Questionnaire (s-IPAQ) (15). * frequency intensity time (FIT) index of kasari (16). :\* SLE Disease activity Index(SLEDAI)(18)
Fifty apparently healthy controls	Complete blood count	CBC with assessment of NLR and PLR. Immumological tests (RF, ANA, anti-ds DNA). * Functional Performance Tests:(12) * Fatigue severity scale (13). * Short-Form Health Survey 36 (SF-36) (14). * the short version of the International Physical activity Questionnaire (s-IPAQ) (15). * frequency intensity time (FIT) index of kasari (16).

Primary Outcome Measures

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