An observational study in Rheumatoid Arthritis (RA, sponsored by Firat University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-09-19.
Sponsored by Firat University · Observational
In RA, joint structure is damaged due to destructive inflammation in the synovium. This condition negatively affects the patient's level of physical activity. As the patient becomes more immobile, their muscle mass and strength decrease and their aerobic capacity declines. One of the drug groups used in the pharmacological treatment of RA is anti-TNF-α drugs. The aim of this study is to investigate the effects of anti-TNF-α and non-TNF-α drug treatments on aerobic capacity, muscle strength, fatigue, cardiorespiratory risk factors, and disease activity in RA patients.
The basic principle in the treatment of rheumatoid arthritis is to prolong the period of remission in patients. Even if complete remission is not achieved, improvements in symptoms and clinical findings enable patients to maintain their functional capacity at a certain level, which is important for their quality of life. To this end, a multidisciplinary approach involving exercise therapy, pharmacological treatment, and psychological support is applied. The primary goal of pharmacological treatment is to intervene in inflammatory pathways. While there are studies in the literature on the relationship of these pharmacological agents with other disease-related mediators and the clinical course of the disease, no studies have been found that examine the relationship between aerobic capacity, which is one of the basic indicators of the patient's functional level, and fatigue, cardiorespiratory risk factors, and quality of life, which are related to aerobic capacity. Based on the results of the study, the aim was to compare the effects of anti-TNF-α and non-TNF-α drugs on aerobic capacity, fatigue, muscle strength, cardiovascular disease risk factors, and disease activity in RA patients.
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This study's planned enrollment of 40 is below the median of 176 across 824 observational studies indexed under Arthritis, Rheumatoid.
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The study will include 40 patients aged 18-65 who are being followed up at the Department of Rheumatology at Fırat University Hospital and who have been diagnosed with RA according to the 2010 RA criteria of the American College of Rheumatology (ACR).
Exclusion Criteria:
20 participants will consist of patients using anti-TNF-α drugs.
20 participants will consist of patients using non-TNF-α drugs.
Maximal Oxygen Consumption
VO2max will be assessed using Cosmed FitMate Pro® (Cosmed, Italy). The FitMate Pro® includes a turbine flow meter to measure ventilation and a galvanic fuel cell oxygen sensor to analyze the oxygen fraction in exhaled gases. The FitMate Pro® performs self-calibration before each measurement. A face mask will be placed over the participant's face to sample exhaled air, which will then be connected to the turbine flow meter. After resting for 5 minutes (while seated on the ergometer), participants will be asked to begin pedaling on the bicycle ergometer (E200 Cosmed®, Italy) starting at 25W. The load will be increased by 25W every 3 minutes until exhaustion.
Time frame: First Day 1
Fatigue Severity Scale
There are nine questions related to fatigue on this scale. Patients are asked to rate these questions on a scale of 1 to 7. The assessment results in a score between 9 and 63. A higher score indicates greater fatigue.
Time frame: First Day 1
Sarcopenia assessment
In the assessment of sarcopenia, patients' gross grip strength will be evaluated. Gross grip strength will be assessed using the Jamar Hand Dynamometer. The Jamar Hand Dynamometer is a method recommended by the American Association of Occupational Therapists (AAOT) for measuring hand grip strength, and is considered the gold standard with proven validity and reliability.
Time frame: First Day 1
Cardiovascular Disease Risk Factors
Cardiovascular risk factors will be assessed using Framingham risk factors. The risk factors assessed in the Framingham Risk Score are age, gender, total cholesterol level, HDL cholesterol level, systolic blood pressure/use of medication for high blood pressure, and smoking. In the Framingham Risk Score, patients are categorized into three groups: high, moderate, and low risk. Patients with a 10-year risk of adverse events \>20% are considered high risk, those with a risk of 10-20% are considered moderate risk, and those with a risk of \<10% are considered low risk.
Time frame: First Day 1
Quality of Life Assessment
The scale was developed for use in individuals with RA and is designed to be completed by the patients themselves. The scale consists of 30 questions, which are scored as "yes-1" and "no-0." The resulting scores range from 0 to 30, with higher scores indicating poorer quality of life.
Time frame: First Day 1
Disease Activity Assessment
The Disease Activity Score-28 (DAS-28) will be used to assess disease activity. Twenty-eight joints, including fingers, wrists, elbows, shoulders, and knees, are examined for tenderness and swelling. Patients are asked to assign a score between 0 and 100 for their overall well-being. Erythrocyte sedimentation rate (ESR) and C-reactive protein are determined, and DAS-28 is calculated using all of these data. High scores indicate high disease activity
Time frame: First Day 1
Plan to share: No
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Firat University