Rheumatoid Arthritis and Osteosarcopenia: Associated Factors
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorKonya Beyhekim Training and Research Hospital
About this trial
Our study is a cross-sectional study, and its aim is to compare and analyze the prevalence of sarcopenia and osteoporosis in patients with rheumatoid arthritis (RA) with a control group and to reveal the impact of sarcopenia on osteoporosis, fall risk, and fracture risk. This prospective cross-sectional study will include 100 rheumatoid arthritis patients and 100 healthy controls, matched for age and sex. Patients will be consecutively and meticulously enrolled based on inclusion and exclusion criteria.
A detailed medical history and examination will be performed on the patients, and their clinical and sociodemographic characteristics will be recorded. Blood tests for RA (RF, Anti-Cyclic Citrullinated Peptide (anti-CCP), CRP, ESR) and disease activity levels (DAS28) will be recorded. The prevalence of osteosarcopenia will be assessed in both the RA and healthy control groups.These groups will be evaluated using various scales and tests (including power, performance tests) including musculoskeletal ultrasonographic measurements and clinical functional assessment tests. he sarcopenic group will be categorized based on the level of sarcopenia, according to the new ISarcoPRM criteria (non-sarcopenic, dynapenic, sarcopenic, and severe sarcopenic). Osteosarcopenia will be evaluated for both groups, and the collected data will be analyzed with primary and secondary outcomes. The analysis will explore the potential relationships between rheumatoid inflammation, sarcopenia, and osteoporosis.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Being diagnosed with RA according to the ACR/EULAR 2010 criteria
Being a female or male over the age of 50
Having the mental and physical capacity to complete the study questionnaires and tests
Providing voluntary consent to participate in the study by signing the Informed Consent Form
Disqualifiers
Having an acute illness/disability or significant cognitive impairment that prevents understanding and performing the required tests
Having thyroid or parathyroid disease, uncontrolled diabetes, Cushing's syndrome, anemia.
History of malignancy
Severe cardiovascular disease, enal failure, advanced-stage COPD, decompensated liver disease
Trial population
The study will include consecutively 100 patients with RA aged 50 and over, who have been diagnosed according to the ACR/EULAR 2010 classification criteria (who have visited the Physical Medicine and Rehabilitation and Rheumatology outpatient clinics) and 100 age- and gender-matched healthy control subjects.
Trial design
Design model
Ecologic or community
Time perspective
Cross-sectional
Treatments tested in this trial
Osteosarcopenia in Patients with Rheumatoid Arthritis
Diagnostic testThe prevalence of osteosarcopenia will be examined in this group. Sarcopenia will be categorized into 4 groups. Both the prevalence of osteosarcopenia and the subgroups of sarcopenia will be compared with the healthy control group. Through this comparison, we will explain the relationship between sarcopenia and osteoporosis, the factors affecting this relationship, and the changes in fall and fracture risk using various questionnaires and tests.
Osteosarcopenia in Healthy Control Group
Diagnostic testThe prevalence of osteosarcopenia will be examined in this group. Sarcopenia will be categorized into 4 groups. The relationship between sarcopenia and osteoporosis, the factors affecting this relationship, and the risk of falls and fractures will be evaluated using various questionnaires and tests.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: rheumatoid arthritis grups1 intervention
Group B: healty control grups1 intervention
Trial outcomes
Primary outcomes
1
Sarcopenia assessment
According to the ISarcoPRM (2021) diagnostic algorithm and the reference values based on its threshold, participants were categorized into sarcopenia groups (no sarcopenia, dynapenia, sarcopenia, severe sarcopenia).
Time frame
baseline2
Osteoporosis assessment/dual-energy X-ray absorptiometry
Dual-energy X-ray absorptiometry (DXA) measurements will be reviewed. In the lumbar spine, femoral neck, or total femur; a T score ≥ -1.0 is considered normal, -1 \> T score \> -2.5 is osteopenia, and T score ≤ -2.5 is defined as osteoporosis.
Time frame
baseline3
Balance and Gait Assessment Scale
This scale is an important tool to evaluate the individual's functional status and daily living activities. The scale consists of a maximum of 16 points for balance and a maximum of 12 points for walking, for a total of 28 points. Individuals who score 26 or below on the scale are thought to have a problem; For those with scores of 19 or below, it is observed that the risk of self-falling increases fivefold compared to normal individuals.
Time frame
baselineSecondary outcomes
1
Fracture Risk Assessment Tool (FRAX)
The Fracture Risk Assessment Tool (FRAX) will be calculated using the Turkish population version. The World Health Organization developed this web-based scoring system to assess the 10-year risk of hip fractures or major osteoporotic fractures based on fracture risk factors. According to the FRAX scoring system, treatment is recommended when the major osteoporotic fracture risk is 20% or higher, and the 10-year hip fracture risk is 3% or above.
Time frame
baseline2
Health Assessment Questionnaire, HAQ
It can assess RA patients in all dimensions, such as disability and discomfort. It includes sections that evaluate disability with 20 questions, pain with one question, and global health status with one question. The disability index includes 8 areas that assess dressing and self-care, getting up, eating, walking, hygiene, reaching, grasping, and normal daily activities. Each section is scored individually, and the average of the 8 sections is recorded. This survey score ranges from 0 to 3. As the score increases, the health condition worsens.
Time frame
baseline3
Handgrip Strength Test
According to the protocol recommended by the American Society of Hand Therapists in 1992, measurements will be taken while patients are seated, with the shoulder in neutral rotation and adduction, the elbow at 90° flexion, the forearm in a neutral position, and the wrist in 30 degrees of dorsiflexion. Patients will be instructed to squeeze the dynamometer with all their strength using similar words and tone. Grip strength will be measured for both hands. Measurements will be taken three times with 1-minute rest intervals, and the maximum value will be recorded. According to the ISarcoPRM (2021) diagnostic algorithm, values below \<32 kg for men and \<19 kg for women will be considered as reduced muscle strength.
Time frame
baseline4
chair rise test
The five-time chair rise test is a measure used to assess lower extremity muscle strength. The patient will be asked to cross their arms over their chest and sit down and stand up from the chair five times as quickly as possible, with the time being recorded. If the time exceeds 12 seconds, it will be considered a reduction in muscle strength.
Time frame
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Source ClinicalTrials.gov