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临床试验/NCT06697028
NCT06697028已完成不适用

Assessment of Cardiorespiratory Fitness Using the Progressive Aerobic Cardiovascular Endurance Run in Patients With Juvenile Idiopathic Arthritis and Familial Mediterranean Fever: A Healthy Control Study

Istanbul University - Cerrahpasa1 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2024年12月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
216
试验地点
1
主要终点
Progressive Aerobic Cardiovascular Endurance Run (PACER)

研究概览

简要总结

Juvenile Idiopathic Arthritis (JIA) and Familial Mediterranean Fever (FMF) are the most common autoimmune and autoinflammatory rheumatic diseases in childhood. Symptoms such as reduced muscle strength, joint pain, fatigue, and limited activity, which are common in childhood rheumatic diseases, often lead to impaired physical function. Cardiorespiratory fitness, which is an important indicator of physical function, plays a critical role in health-related outcomes in children and adolescents with rheumatic disease. Maximum oxygen consumption (VO2 peak) is considered the fundamental criterion for evaluating cardiorespiratory fitness. The need for extensive equipment and trained personnel, accompanied with the inability to assess large numbers of children at one-time makes the objective assessment of cardiorespiratory fitness in a clinic setting unmanageable. Therefore, there is a need to assess their cardiorespiratory fitness utilizing an easily administered test that has minimal measurement errors in patients with JIA and FMF. The Progressive Aerobic Cardiovascular Endurance Run (PACER) has become a routine cardiorespiratory fitness assessment for predicting VO2peak in children. A review of the literature revealed that no studies have evaluated CRF using PACER in childhood rheumatic diseases. The aim of this study was to compare the Fitnessgram VO2 max values of children and adolescents diagnosed with JIA and FMF with those of their healthy peers and to examine the relationship with body composition.

研究设计

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

入排标准

年龄范围
12 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Did not have any chronic disease other than rheumatic disease
  • Diagnosed with rheumatic disease at least 6 months ago
  • Had stable medical treatment
  • Being between the ages of 12 and 18
  • Volunteering to participate in the study

排除标准

  • Have experienced trauma or surgery affecting the musculoskeletal system within the last 6 months
  • Have acute pain for any reason, have visual or hearing problems
  • Have cognitive impairment
  • Not volunteering to participate in the study

结局指标

主要结局

Progressive Aerobic Cardiovascular Endurance Run (PACER)

时间窗: Baseline

The PACER test is an adapted version of the 20-meter shuttle run test and consists of multiple stages, serving as a field test. It allows children and adolescents to set their own pace and warm up, serving as a more enjoyable alternative to other distance running tests recommended for use in children, adolescents, and young adults. Utilized to assess patients' cardiorespiratory fitness, individuals were instructed to run back and forth between two cones within a 20-meter course, to the rhythm of music played through a sound recording device, with the test starting at a slow pace and gradually increasing in speed every minute.

Body Mass Index

时间窗: Baseline

Body mass index (BMI), will determined by dividing the body weight in kilograms by the square of the height in meters.

VO2 max

时间窗: Baseline

Using the FitnessGram software, the maximum oxygen consumption value (VO2max) will calculated for each individual based on the number of laps completed.

次要结局

未报告次要终点

研究者

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

Asya Albayrak

MSc

Istanbul Kent University

研究点 (1)

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