Rheumatic DiseasesNCT03728231
Disease Activity in RA and SLE Patients and Its Relation to Muscle Performance,Fatigue and Blood Parameters
An observational study of Rheumatic Diseases, run by Assiut University.
Trial summary
Assessment of disease activity in Rheumatoid Arthritis and Systemic lupus patients related to muscle performance, fatigue and blood parameters Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rheumatic Diseases
- What is being tested?
- Complete blood count
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2018to 2 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Patients with end stage organ failure.
- Patients with malignancies.
- Patients receiving any medications affect blood picture.
About this study
Official title: Disease Activity in Rheumatoid Arthritis and Systemic Lupus Erythematosus and Its Relation to Muscle Performance,Fatigue and Blood Parameters
Assessment of disease activity in Rheumatoid Arthritis and Systemic lupus patients related to muscle performance, fatigue and blood parameters
Read the 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 .
- Conditions
- Rheumatic Diseases
- Being tested
- Complete blood count
- Medical subject headings
- Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete blood countOther
Also called Immunological tests, ESR and CRP
taking blood sample from venous blood
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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). Receives: Other: Complete blood count |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2018
- Study start15 Nov 2018 (estimated)
- Primary completion11 Nov 2019 (estimated)
- Study completion2 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Rheumatic DiseasesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Gamal Seddek, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03728231
- Sponsor's protocol ID
- DAS in RA and SLE
- Status last verified
- Oct 2018
- First submitted
- 24 Oct 2018
- Last updated
- 2 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 24785098Hakkinen 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.
PubMed 15901635Summers 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.
PubMed 20647995Alaranta 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.
PubMed 7878396
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disease Activity in Rheumatoid Arthritis and Systemic Lupus Erythematosus and Its Relation to Muscle Performance,Fatigue and Blood Parameters
- ClinicalTrials.gov ID
- NCT03728231
- Acronym / sponsor ID
- DAS in RA and SLE
- Conditions
- Rheumatic Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Nov 2018 (estimated)
- Primary completion
- 11 Nov 2019 (estimated)
- Study completion
- 2 Feb 2020 (estimated)
- First posted
- 2 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fifty patients with RA. | – | Other: Complete blood count-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) |
| Fifty patients with SLE. | – | Other: Complete blood countCBC 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) |
| Fifty apparently healthy controls | – | Other: Complete blood countCBC 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complete blood countAlso: Immunological tests, ESR and CRPtaking blood sample from venous blood | Other | Fifty apparently healthy controls, Fifty patients with RA., Fifty patients with SLE. |
Primary outcome
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 .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2018.
- Background: PubMed 24785098Biolo 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.
- Background: PubMed 15901635Hakkinen 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.
- Background: PubMed 20647995Summers 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.
- Background: PubMed 7878396Alaranta 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.
- 9.Balsamo et al. BMC MusculoskeletalDisorders 2013, 14:263Link provided by the sponsor.
- 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; 33:737-748Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatic Diseases, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
estimation of muscle performance in Rheumatoid arthritis and Systemic lupus patients by 30_s chair stand test (repetition 4_12) . (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03728231, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2018; AzTrials last refreshed its copy on 26 Oct 2026.