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

Rheumatic Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03728231
• Other study ID #: DAS in RA and SLE
• Status: Not yet recruiting
• Start date: November 15, 2018
• Est. completion date: February 2, 2020

Study information

• Verified date: October 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: February 2, 2020
• Est. primary completion date: November 11, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Collagen Diseases
• Fatigue
• Rheumatic Diseases

Intervention

Other:
• Complete blood count
taking blood sample from venous blood

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (4)

Alaranta H, Hurri H, Heliövaara M, Soukka A, Harju R. Non-dynamometric trunk performance tests: reliability and normative data. Scand J Rehabil Med. 1994 Dec;26(4):211-5. — View 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. — View Citation

Häkkinen A, Kautiainen H, Hannonen P, Ylinen J, Mäkinen 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. Epub 2005 May 18. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   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
•   9.Balsamo et al. BMC MusculoskeletalDisorders 2013, 14:263