Assessment of Cardiorespiratory Fitness Using the PACER in Patients With Juvenile Idiopathic Arthritis and Familial Mediterranean Fever

NCT06697028 — Completed, 216 participants, Istanbul University - Cerrahpasa

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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

Registry	NCT06697028
Status	Completed
Study type	Observational
Enrollment	216 (Actual)
Sponsor	Istanbul University - Cerrahpasa (Other)
Conditions	Juvenile Idiopathic Arthritis, Familial Mediterranean Fever, Healty Controls
Interventions	Usability and Comparison (Other)
Dates	start 2024-12-25, primary completion 2025-01-11, completion 2025-05-11, first posted 2024-11-20, last updated 2025-06-05
Locations	1 site in Turkey (Türkiye)

-Summary

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.

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+Arms and interventions

Arm	Interventions	Description
Juvenile Idiopathic Arthritis	Other: Usability and Comparison	Patients diagnosed with JIA followed at the Pediatric Rheumatology Clinic, Department of Pediatrics, Istanbul Faculty of Medicine, will be evaluated.
Familial Mediterranean Fever	Other: Usability and Comparison	Patients diagnosed with FMF followed at the Pediatric Rheumatology Clinic, Department of Pediatrics, Istanbul Faculty of Medicine, will be evaluated.
Healthy control	Other: Usability and Comparison	The outcomes of individuals with rheumatic diseases will be compared with those of healthy controls.

Usability and Comparison (Other): PACER will be used to assess cardiorespiratory fitness in individuals with rheumatic diseases. The results will be compared with those of healthy individuals, and the relationship between body composition and VO2 max will be examined.

+Outcome measures

Primary outcomes

Progressive Aerobic Cardiovascular Endurance Run (PACER) [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 [Baseline]: Body mass index (BMI), will determined by dividing the body weight in kilograms by the square of the height in meters.
VO2 max [Baseline]: Using the FitnessGram software, the maximum oxygen consumption value (VO2max) will calculated for each individual based on the number of laps completed.

+Eligibility

Sex: All, ages: 12 Years to 18 Years, accepts healthy volunteers

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

+Locations (1)

Facility	City	Country	Status
Istanbul University-Cerrahpasa	Istanbul	Turkey (Türkiye)