Investigation Of The Effects Of Anti-Tnf-Α And Non-Tnf-Α Drugs İn Patients With Rheumatoid Arthritis

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-65
SponsorFirat University

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

40 Participants
are grouped into 2 trial groups
Group A: People Using Anti-TNF-α Medication
Group B: People Using Non-TNF-α Medication

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

Other outcomes

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
2

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
3

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
4

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

Sponsors and contacts

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