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临床试验/NCT07182630
NCT07182630尚未招募不适用

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

Firat University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Maximal Oxygen Consumption

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Maximal Oxygen Consumption

时间窗: First Day 1

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.

次要结局

未报告次要终点

研究者

发起方
Firat University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmet Seçkin Korkmaz

Principal Investigator

Firat University

研究点 (1)

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