SarcopeniaNCT06284200
Presence and Comparison of Sarcopenia in Early Rheumatoid Arthritis and Rheumatoid Arthritis
An observational study of Sarcopenia, run by Kayseri City Hospital at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcopenia
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Jun 2023to 23 Jun 2024
- How long will I take part?
- 1 Day
- 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
- No healthy volunteers
- Adult, Older adult
Study population: In the planned single-center study, patients with clinically confirmed RA and early RA diagnosed who applied to Kayseri City Hospital Physical Medicine and Rehabilitation outpatient clinic will be included in the study after their consent is obtained.
Who may be able to join
- 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)
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Health Sciences University, Kayseri Medicine Faculty
Kocasinan, Kayseri, 38125
MEHMET KÖKSAL, M.D., +905514043114, dr.mhmtkksl@gmail.com
About this study
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.
Read the detailed description
According to the power analysis, 24 patients with early rheumatoid arthritis and 24 patients with established rheumatoid arthritis who met the 2010 ACR / EULAR RA classification criteria will be included in the study. The presence of sarcopenia will be evaluated according to the European Working Group on Sarcopenia in Older People (EWGSOP-2) criteria by performing hand grip strength, muscle mass measurement with Bioelectrical Impedance Analysis (BIA), and 4-meter general walking speed tests. Demographic data of the patients and anti-nuclear antibody (ANA), rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) levels, Simplified Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI), Disease Activity Score ( DAS)28, functional status (health assessment questionnaire (HAQ)), quality of life (RA quality of life scale (RAQoL)), anxiety and depression (hospital anxiety and depression scale (HADS)) results will be evaluated.
- Conditions
- Sarcopenia
- Keywords
- Early Rheumatoid Arthritis, Sarcopenia, Rheumatoid Arthritis, Appendicular Skeletal Muscle Mass Index
- Medical subject headings
- Sarcopenia, Arthritis, Rheumatoid
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Muscle Mass
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.
Measured: once at the baseline
Evaluation of Muscle Strength
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.
Measured: once at the baseline
Evaluation of Muscle Performance
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.
Measured: once at the baseline
Secondary outcomes (3)
Rheumatoid Arthritis Quality of Life Scale
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.
Measured: once at the baseline
Health Assessment Questionnaire (HAQ)
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.
Measured: once at the baseline
Hospital Anxiety and Depression Scale (HADS)
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.
Measured: once at the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start23 Jun 2023
- Primary completion23 Mar 2024 (estimated)
- Study completion23 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 48 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kayseri City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Havva Talay Çalış, Kayseri City Hospital
- Investigators
- HAVVA TALAY ÇALIŞ, PROF, Study director, Health Sciences University, Kayseri Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06284200
- Sponsor's protocol ID
- sarcopenia eRA
- Status last verified
- Feb 2024
- First submitted
- 21 Feb 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Presence and Comparison of Sarcopenia in Early Rheumatoid Arthritis and Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT06284200
- Acronym / sponsor ID
- sarcopenia eRA
- Conditions
- Sarcopenia
- Keywords
- Early Rheumatoid Arthritis, Sarcopenia, Rheumatoid Arthritis, Appendicular Skeletal Muscle Mass Index
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Kayseri City HospitalOther government
- Study start
- 23 Jun 2023 (actual)
- Primary completion
- 23 Mar 2024 (estimated)
- Study completion
- 23 Jun 2024 (estimated)
- First posted
- 28 Feb 2024 (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.
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.
Detailed description
According to the power analysis, 24 patients with early rheumatoid arthritis and 24 patients with established rheumatoid arthritis who met the 2010 ACR / EULAR RA classification criteria will be included in the study. The presence of sarcopenia will be evaluated according to the European Working Group on Sarcopenia in Older People (EWGSOP-2) criteria by performing hand grip strength, muscle mass measurement with Bioelectrical Impedance Analysis (BIA), and 4-meter general walking speed tests. Demographic data of the patients and anti-nuclear antibody (ANA), rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) levels, Simplified Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI), Disease Activity Score ( DAS)28, functional status (health assessment questionnaire (HAQ)), quality of life (RA quality of life scale (RAQoL)), anxiety and depression (hospital anxiety and depression scale (HADS)) results will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In the planned single-center study, patients with clinically confirmed RA and early RA diagnosed who applied to Kayseri City Hospital Physical Medicine and Rehabilitation outpatient clinic will be included in the study after their consent is obtained.
Key inclusion criteria (5 listed)
- 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)
- 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
Key exclusion criteria (8 listed)
- Presence of other rheumatic disease
- Presence of malnutrition
- Recent surgical history,
- Stroke history,
- Pregnancy,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
3 secondary outcomes
Rheumatoid Arthritis Quality of Life Scale
Time frame: once at the baseline
Health Assessment Questionnaire (HAQ)
Time frame: once at the baseline
Hospital Anxiety and Depression Scale (HADS)
Time frame: once at the baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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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.
HAVVA TALAY ÇALIŞ, PROF study director
Health Sciences University, Kayseri Medical Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia, run by Kayseri City Hospital at 1 site in Turkey (Türkiye).
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 8 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 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact HAVVA TALAY ÇALIŞ, PROF (+905326874541, htalaycalis@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Muscle Mass (time frame: once at the baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2024.