Clinical trial NCT06697028: Assessment of Cardiorespiratory Fitness Using the PACER in Patients With Juvenile Idiopathic Arthritis and Familial Mediterranean Fever
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Juvenile Idiopathic Arthritis
Familial Mediterranean Fever
Healty Controls
Keywords: Cardiorespiratory fitness
Progressive Aerobic Cardiovascular Endurance Run
Body composition
Maximum oxygen consumption
Juvenile Idiopathic Arthritis
Familial Mediterranean Fever
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 216
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with JIA and FMF, and their healthy peers without any chronic diseases or disabilities, all aged between 12 to 18 years old will be evaluated with PACER.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Progressive Aerobic Cardiovascular Endurance Run (PACER)
timeFrame: Baseline
measure: Body Mass Index
timeFrame: Baseline
measure: VO2 max
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
Study officials:
References: