Investigation Of The Effects Of Anti-Tnf-Α And Non-Tnf-Α Drugs İn Patients With Rheumatoid Arthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Rheumatoid Arthritis (RA. Basic parameters: 18 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Investigation Of The Effects Of Anti-Tnf-Α And Non-Tnf-Α Drugs On Aerobic Capacity, Muscle Strength, Fatigue, Cardiovascular Disease Risk Factors, And Disease Activity İn Patients With Rheumatoid Arthritis
Overview
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.
Detailed description
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.
Primary outcome measures
- Maximal Oxygen Consumption [Time frame: First Day 1]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
- Having cardiac symptoms according to the New York Heart Association
- Having mental problems that prevent participation in assessments
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Turkey (Türkiye) · 1 center
- Fırat University — Elâzığ
Identifiers
NCT: NCT07182630 · FU-FTR-ASK-01