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

NCT ID: NCT03728231

Last Updated: 2018-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-15

Study Completion Date

2020-02-02

Brief Summary

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

Detailed Description

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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 .

Conditions

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Rheumatic Diseases

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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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)

Complete blood count

Intervention Type OTHER

taking blood sample from venous blood

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)

Complete blood count

Intervention Type OTHER

taking blood sample from venous blood

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).

Complete blood count

Intervention Type OTHER

taking blood sample from venous blood

Interventions

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Complete blood count

taking blood sample from venous blood

Intervention Type OTHER

Other Intervention Names

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Immunological tests ESR and CRP

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Maha Gamal Seddek

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type BACKGROUND
PMID: 24785098 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15901635 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20647995 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7878396 (View on PubMed)

Related Links

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http://www.biomedcentral.com/1471-2474/14/263

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

https://doi.org

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

Other Identifiers

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DAS in RA and SLE

Identifier Type: -

Identifier Source: org_study_id

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