- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06284200
Presence and Comparison of Sarcopenia in Early Rheumatoid Arthritis and Rheumatoid Arthritis
introduction: In this study, the presence of sarcopenia in cases with early rheumatoid arthritis and established rheumatoid arthritis will be compared.
Materials and Method: According to the power analysis, 24 patients with early rheumatoid arthritis and 24 patients with established rheumatoid arthritis who meet the 2010 American College of Rheumatology (ACR) / European Alliance of Associations for Rheumatology (EULAR) rheumatoid arthritis (RA) classification criteria will be included in the study.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: HAVVA TALAY ÇALIŞ, PROF
- Phone Number: +905326874541
- Email: htalaycalis@yahoo.com
Study Contact Backup
- Name: MEHMET KÖKSAL, MD
- Phone Number: +905514043114
- Email: dr.mhmtkksl@gmail.com
Study Locations
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Kayseri
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Kocasinan, Kayseri, Turkey, 38125
- Recruiting
- Health Sciences University, Kayseri Medicine Faculty
-
Contact:
- MEHMET KÖKSAL, M.D.
- Phone Number: +905514043114
- Email: dr.mhmtkksl@gmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Inclusion criteria for the early RA group:
- To be diagnosed with RA according to the 2010 ACR (American Society for the Study of Rheumatism) / EULAR (European Association for the Study of Rheumatism) RA classification criteria
- Being 18 years or older
- Being followed up with a diagnosis of RA for less than 1 year (early RA)
Inclusion criteria for the RA group:
- To be diagnosed with RA according to the 2010 ACR (American Society for the Study of Rheumatism) / EULAR (European Association for the Study of Rheumatism) RA classification criteria
- Being 18 years or older
Exclusion Criteria:
- Presence of other rheumatic disease
- Presence of malnutrition
- Recent surgical history,
- Stroke history,
- Pregnancy,
- Presence of prosthesis or metal implant,
- Presence of a pacemaker,
- Patients over 140 kg
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of Muscle Mass
Time Frame: once at the baseline
|
Muscle mass evaluations in patients will be made using the Bioelectrical Impedance Analysis (BIA) (Multi Frequency Segmental Body Composition) method.
According to the data obtained from the BIA device, appendicular skeletal muscle mass index (ASMI).
The ASMI cut-off point recommended by the EuropeanWorkingGroup on Sarcopenia in Older People (EWGSOP2) would be <7.26
kg/m2 for men and <5.5 kg/m2 for women.
Patients with low ASMI will be evaluated as having sarcopenia.
|
once at the baseline
|
Evaluation of Muscle Strength
Time Frame: once at the baseline
|
In general, hand grip strength is one of two methods used to measure muscle strength in patients with suspected sarcopenia.
Hand grip strength is related to strength in other muscles and can therefore be used as a tool to demonstrate muscle weakness.
The hydraulic hand dynamometer will be used in all patients included in this study, and measurements will be recorded in kilogram.
Measurements will be made with the patient in a sitting position on a chair, with the elbow close to the body and 90 degrees of flexion, and the wrist in neutral.Patients will be asked to grasp the dynamometer as firmly as possible.
Three measurements will be taken for the patients and the average was taken.
The recommended cut-off point for the hand grip test will be considered to be <27 kg for men and <16 kg for women.Patients with low hand grip strength will be evaluated as having possible sarcopenia.
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once at the baseline
|
Evaluation of Muscle Performance
Time Frame: once at the baseline
|
Physical performance will be evaluated with a 4-meter general walking speed test.
The patient will be asked to walk a distance of 4 meters at his normal pace, as in his daily life, and the time to walk the distance of 4 meters will be calculated in seconds.
4 meter general walking speed will be calculated in m/sec and speeds below 0.8 m/sec will be considered low walking speed.
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once at the baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rheumatoid Arthritis Quality of Life Scale
Time Frame: once at the baseline
|
The Turkish version of the Rheumatoid Arthritis Quality of Life Scale (RAQoL), prepared for use in the Turkish population, is valid, reliable and practical to use in clinical studies.
It is recommended that the scale be used in the individual monitoring of patients with RA and in the evaluation of treatment effectiveness in clinical studies.
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once at the baseline
|
Health Assessment Questionnaire (HAQ)
Time Frame: once at the baseline
|
The HAQ was developed by Fries et al. in 1980 to evaluate the physical limitations of patients with Rheumatoid Arthritis.
It gauges activities of daily living consisting of 20 items in 8 sections.
Each item is scored between 0-3 (0: no difficulty at all, 1: some difficulty, 2: great difficulty, 3: cannot do it at all).
High score means low functionality.
The scale was adapted to Turkish society.
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once at the baseline
|
Hospital Anxiety and Depression Scale (HADS)
Time Frame: once at the baseline
|
Anxiety and depression will measured by using HADS, which is a 14-item questionnaires with 7 responses each for anxiety and depression with a maximum possible score of 3 for a particular response.
A score of up to 7 is considered normal, with scores of 8-10 as borderline abnormal and scores 11-21 as being abnormal.
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once at the baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: HAVVA TALAY ÇALIŞ, PROF, Health Sciences University, Kayseri Medical Faculty
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Immune System Diseases
- Autoimmune Diseases
- Neurologic Manifestations
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Neuromuscular Manifestations
- Pathological Conditions, Anatomical
- Muscular Atrophy
- Atrophy
- Arthritis
- Arthritis, Rheumatoid
- Sarcopenia
Other Study ID Numbers
- sarcopenia eRA
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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