Assessment of Cardiorespiratory Fitness Using the PACER in Patients With Juvenile Idiopathic Arthritis and Familial Mediterranean Fever
NCT06697028
Arthritis, Arthritis, Juvenile
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT Number: NCT07617558
Juvenile Idiopathic Arthritis (JIA) and Familial Mediterranean Fever (FMF), two of the most prevalent pediatric rheumatologic diseases, significantly compromise the physical health of children and adolescents, leading to reduced physical fitness, muscle weakness, and a sedentary lifestyle. This study aims to evaluate the validity and reliability of the International Fitness Scale (IFS) and the Self-Perceived Health-Related Fitness Questionnaire for Children (PHFQ-C) as assessment tools for physical fitness in individuals diagnosed with JIA and FMF. Our hypothesis is that these scales will provide demonstrably reliable and valid data within this patient population. To test this, 98 patients aged 10-18 years, recruited from the Pediatric Rheumatology Clinic at Istanbul Faculty of Medicine, will participate. Their physical fitness will be objectively measured using the FitnessGram Test Battery (assessing aerobic capacity, muscular strength, and flexibility), while the IFS and PHFQ-C will be administered online. Statistical analysis, conducted using SPSS 25.0, will employ Pearson/Spearman correlation for validity and Cronbach's alpha and test-retest Intraclass Correlation Coefficient (ICC) for reliability.
The expected findings will confirm the utility of the IFS and PHFQ-C as practical, economical, and valid instruments for assessing physical fitness in children and adolescents with JIA/FMF. Promoting the widespread use of these scales in clinical settings will facilitate the rapid and convenient evaluation of patients' fitness levels, thereby enabling the development of early, targeted intervention strategies and ultimately contributing to an improved quality of life. Furthermore, by offering a validated alternative to standard test batteries-which are often cumbersome due to requirements for time, specialized equipment, and expert personnel-this work will make a valuable methodological contribution to the existing scientific literature.
Trial opening soon.
Get Notified10 year–18 year
All sexes
Observational
Pediatric rheumatologic diseases are a group of chronic inflammatory conditions that affect multiple organ systems and are characterized by periods of flare-ups. These conditions encompass diverse groups of disorders, including inflammatory arthritis, autoinflammatory syndromes, vasculitis, and other autoimmune diseases. While Juvenile Idiopathic Arthritis (JIA) is the most common rheumatologic disease in childhood and adolescence, Familial Mediterranean Fever (FMF) is another major and frequently encountered rheumatologic condition in the pediatric population in Turkey. FMF is an autosomal recessive autoinflammatory disease, typically manifesting in childhood and presenting with recurrent episodes of fever and pain. JIA is defined as a heterogeneous group of rheumatic inflammatory diseases characterized by arthritis of unknown etiology that begins before the age of 16 and lasts for at least six weeks.
These pediatric rheumatologic conditions are often marked by pain, which can lead to limited joint mobility, muscle weakness, and fatigue. Individuals experiencing pain symptoms generally exhibit reduced physical function compared to those who are pain-free. Due to the chronic nature of the disease, frequent attacks, and associated symptoms, individuals with FMF and JIA face significant challenges such as a sedentary lifestyle, physical inactivity, decreased muscle strength, fatigue, low physical fitness, and overall reduced physical function. Several studies have consistently demonstrated low levels of physical fitness in children with JIA and adolescents with FMF.
The evaluation of physical fitness in children and adolescents is crucial for identifying developmental differences and allowing for the early detection of potential health problems that may persist into adulthood. While validated and reliable, current physical fitness test batteries frequently encounter practical barriers during field application, including limitations in space, equipment, time constraints, and the need for specialized personnel. These limitations highlight a pressing need for standardized, easily administered scales to facilitate routine clinical assessment.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Until one week after registration
The scale developed by Fox and Corbin (1989) assesses self-perceived physical fitness based on a four-factor structure, consisting of cardiovascular endurance, muscular flexibility, muscular strength, and body composition (28). Subsequently, a muscular endurance factor was added, yielding the final version of the questionnaire with five dimensions of physical fitness. The instrument comprises two main sections. In the first section, five key components-cardiorespiratory fitness, muscular fitness, flexibility, and body composition-are evaluated using a scale scored from 1 to 5. In the second section, children assess their own physical fitness in comparison with their peers. The total score obtained from the questionnaire ranges from 9 to 45. Except for the body composition item, lower scores on the other items are associated with better physical fitness. In prepubertal Spanish children, ASFU-C exhibited high test-retest reliability and moderate validity across other variables.
Time frame: Until one week after the registration date
The instrument developed by Ortega et al. is a practical self-administered scale designed to assess physical fitness in individuals (24). The scale consists of five domains: overall physical fitness, cardiorespiratory endurance, muscular strength, speed/agility, and flexibility. To examine various components of physical fitness, a five-point Likert scale is employed, ranging from "very good" to "good," "average," "poor," and "very poor." Having been translated into nine different languages, the scale has demonstrated structural reliability and validity across diverse populations, including adolescent cohorts in Brazil, Spain, Colombia, Chile, and several European countries (24, 27).
Time frame: Until one week after registration
The FitnessGram, developed by the Cooper Institute, is a valid and reliable test battery designed to assess health-related physical fitness. The FitnessGram Test Battery is a comprehensive assessment tool that includes evaluations of aerobic capacity (PACER), body composition (skinfold thickness measurement, body mass index), abdominal muscle strength and endurance (curl-up test), trunk extensor strength and flexibility (trunk lift test), upper extremity muscle strength and endurance (90° push-up test), and flexibility (back-saver sit-and-reach test) (29). In the present study, physical fitness will be assessed using the following components of the FitnessGram Test Battery: the Progressive Aerobic Cardiovascular Endurance Run (PACER), curl-up test, trunk lift test, 90° push-up test, back-saver sit-and-reach test, and skinfold thickness measurement.
The Progressive Aerobic Cardiovascular Endurance Run is a progressive field test recommended for children, adolescents, and adults, condu
Contact information is provided by the study sponsor or research team.
Beyza N Yumak, MSc
CONTACT
+90 (539) 856 14 70 ext. +90
Nilay Arman, Associate Professor
CONTACT
+90 (553) 455 87 07 ext. +90
Istanbul University - Cerrahpasa
Other
Investigation of the Validity and Reliability of the International Physical Fitness Questionnaire and the Self-Perceived Health-Related Physical Fitness Questionnaire for Children in Children and Adolescents Diagnosed With Juvenile Idiopathic Arthritis and Familial Mediterranean Fever
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