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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 : Unknown
Verified October 2018 by Maha Gamal Seddek, Assiut University.
Recruitment status was:  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

Tracking Information
First Submitted Date October 24, 2018
First Posted Date November 2, 2018
Last Update Posted Date November 2, 2018
Estimated Study Start Date November 15, 2018
Estimated Primary Completion Date November 11, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 31, 2018)
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 .
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Rheumatic Diseases
Intervention Other: Complete blood count
taking blood sample from venous blood
Other Names:
  • Immunological tests
  • ESR and CRP
Study Groups/Cohorts
  • 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)
    Intervention: Other: Complete blood count
  • 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)
    Intervention: Other: Complete blood count
  • 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).
    Intervention: Other: Complete blood count
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: October 31, 2018)
150
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 2, 2020
Estimated Primary Completion Date November 11, 2019   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03728231
Other Study ID Numbers DAS in RA and SLE
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Maha Gamal Seddek, Assiut University
Study Sponsor Assiut University
Collaborators Not Provided
Investigators Not Provided
PRS Account Assiut University
Verification Date October 2018