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

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ClinicalTrials.gov Identifier: NCT03728231
Recruitment Status : Not yet recruiting
First Posted : November 2, 2018
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
Maha Gamal Seddek, Assiut University

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

Condition or disease Intervention/treatment
Rheumatic Diseases 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 .


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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: Disease Activity in Rheumatoid Arthritis and Systemic Lupus Erythematosus and Its Relation to Muscle Performance,Fatigue and Blood Parameters
Estimated Study Start Date : November 15, 2018
Estimated Primary Completion Date : November 11, 2019
Estimated Study Completion Date : February 2, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. estimation of muscle performance in Rheumatoid arthritis and Systemic lupus patients by 30_s chair stand test (repetition 4_12) . [ Time Frame: 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 .



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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.

Additional Information:
Publications:
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Responsible Party: Maha Gamal Seddek, Principle Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03728231     History of Changes
Other Study ID Numbers: DAS in RA and SLE
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Fatigue
Rheumatic Diseases
Collagen Diseases
Signs and Symptoms
Musculoskeletal Diseases
Connective Tissue Diseases