About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosed with RA according to the 2010 American College of Rheumatology (ACR-2010) criteria
Be between 18 and 65 years of age
Be literate
Have been using one of the anti-TNF-α or non-TNF-α drugs for a period of 1-3 years
Disqualifiers
Being pregnant or having a diagnosis of malignancy
Having a dysfunction that would limit physical activity (cycling for aerobic capacity assessment), such as severe neurological involvement, immobility, or incooperation
Having a regular exercise habit (reporting a habit of exercising 3 or more days per week)
Having another chronic disease
Trial population
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).
Trial design
Case-control
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Other outcomes
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.
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.
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.
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.
Sponsors and contacts
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