NCT03728231

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 2, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

November 15, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2020

Completed
Last Updated

November 2, 2018

Status Verified

October 1, 2018

Enrollment Period

12 months

First QC Date

October 24, 2018

Last Update Submit

October 31, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

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

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

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

Interventions

taking blood sample from venous blood

Also known as: Immunological tests, ESR and CRP
Fifty apparently healthy controlsFifty patients with RA.Fifty patients with SLE.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • RA diagnosis according to 1987ACR criteria,or 2010 ACR/EULAR criteria
  • SLE diagnosis according to 1982 ACRor 2012 ACRcriteria
  • Patients aged \> 18 years.
  • Stable disease with no activity during last 3 months.
  • Regular medication in last 3 months.

You may not qualify if:

  • Subjects with hematologic disorders other than anaemia.
  • Concomitant infectious or inflammatory diseases such as ulcerative colitis.
  • Liver or kidney disease.
  • Coronary heart disease.
  • Other immunological diseases.
  • Pregnant ladies.
  • Patients with end stage organ failure.
  • Patients with malignancies.
  • Patients receiving any medications affect blood picture.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 24785098BACKGROUND
  • 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.

    PMID: 15901635BACKGROUND
  • 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.

    PMID: 20647995BACKGROUND
  • 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.

    PMID: 7878396BACKGROUND

Related Links

MeSH Terms

Conditions

Rheumatic Diseases

Interventions

Blood Cell CountImmunologic Tests

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cell CountCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHematologic TestsInvestigative TechniquesCell Physiological PhenomenaBlood Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaImmunologic Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

October 24, 2018

First Posted

November 2, 2018

Study Start

November 15, 2018

Primary Completion

November 11, 2019

Study Completion

February 2, 2020

Last Updated

November 2, 2018

Record last verified: 2018-10