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

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

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

Study Overview

• Status: Unknown
• Conditions: Rheumatic Diseases
• Intervention / Treatment: Other: Complete blood count

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 Type: Observational
• Enrollment (Anticipated): 150

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Fifty patients with RA.; -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)	Other: Complete blood count; taking blood sample from venous blood; Other Names: Immunological tests; ESR and CRP
Fifty patients with SLE.; 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)	Other: Complete blood count; taking blood sample from venous blood; Other Names: Immunological tests; ESR and CRP
Fifty apparently healthy controls; 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).	Other: Complete blood count; taking blood sample from venous blood; Other Names: Immunological tests; ESR and CRP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
estimation of muscle performance in Rheumatoid arthritis and Systemic lupus patients by 30_s chair stand test (repetition 4_12) .	use of 30_s chair stand test(repetition 4_12) in detection of degree of muscle performance in Rheumatoid arthritis and Systemic lupus patients .	6 months

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Helpful Links

• 9.Balsamo et al. BMC MusculoskeletalDisorders 2013, 14:263
• 2.Biolo G, Cederholm T, Muscaritoli M. Muscle contractile and metabolic dysfunction isacommonfeature ofsarcopenia of ang and chronic diseases: From sarcopenic obesity to sarcopenic obesity to cachexia. Clin Nutr. 2014; 33:737-748

Study record dates

Study Major Dates

• Study Start (Anticipated): November 15, 2018
• Primary Completion (Anticipated): November 11, 2019
• Study Completion (Anticipated): February 2, 2020

Study Registration Dates

• First Submitted: October 24, 2018
• First Submitted That Met QC Criteria: October 31, 2018
• First Posted (Actual): November 2, 2018

Study Record Updates

• Last Update Posted (Actual): November 2, 2018
• Last Update Submitted That Met QC Criteria: October 31, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Connective Tissue Diseases; Rheumatic Diseases; Collagen Diseases
• Other Study ID Numbers: DAS in RA and SLE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No