- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07617558
Validity and Reliability of the International Physical Fitness Questionnaire and the Self-Perceived Health-Related Physical Fitness Questionnaire in Children and Adolescents With JIA and FMF
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
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.
Panoramica dello studio
Stato
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Nilay Arman, Associate Professor
- Numero di telefono: +90 +90 (553) 455 87 07
- Email: nilayarman@iuc.edu.tr
Backup dei contatti dello studio
- Nome: Beyza N Yumak, MSc
- Numero di telefono: +90 +90 (539) 856 14 70
- Email: beyzanurymk@gmail.com
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Age between 10 and 18 years
- Diagnosis of Familial Mediterranean Fever (FMF) or Juvenile Idiopathic Arthritis (JIA) established by a pediatric rheumatologist at least six months prior
- Voluntary willingness to participate in the study
- Provision of informed consent by both the participant and their parents/guardians
- Ability to ambulate independently, communicate effectively, and comply with the instructions required for the research assessments
- Sufficient literacy to comprehend written instructions and complete study-related materials
Exclusion Criteria:
- Having a history of a mental or psychological problem that would prevent the understanding of questions or compliance with given instructions.
- Medically unstable conditions (history of hospitalization due to heart or lung disease or a disease flare within the 4 weeks prior to the test).
- Having a history of a chronic disease of cardiovascular, orthopedic, neuromuscular, or neurological origin that could affect physical fitness.
- Having a history of trauma affecting the musculoskeletal system within the last 6 months.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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Patients diagnosed with Juvenile Idiopathic Arthritis or Familial Mediterranean Disease
All participants consist of patients aged 10-18 who are followed by the Istanbul Faculty of Medicine Pediatric Rheumatology Outpatient Clinic and have been diagnosed with Juvenile Idiopathic Arthritis (JIA) or Familial Mediterranean Fever (FMF).
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Self-Perceived Health-Related Physical Fitness Questionnaire
Lasso di tempo: Until one week after registration
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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.
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Until one week after registration
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International Fitness Scale
Lasso di tempo: Until one week after the registration date
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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).
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Until one week after the registration date
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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FitnessGram Test Battery
Lasso di tempo: Until one week after registration
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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 |
Until one week after registration
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Collaboratori e investigatori
Sponsor
Investigatori
- Cattedra di studio: Nilay Arman, Associate Professor, Istanbul University - Cerrahpasa
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie muscoloscheletriche
- Artrite
- Malattie articolari
- Malattie reumatiche
- Malattie genetiche, congenite
- Malattie del tessuto connettivo
- Malattie autoimmuni
- Malattie del sistema immunitario
- Malattie autoinfiammatorie ereditarie
- Malattie e anomalie congenite, ereditarie e neonatali
- Malattie della pelle e del tessuto connettivo
- Artrite, giovanile
- Febbre mediterranea familiare
Altri numeri di identificazione dello studio
- hXEd9X7x
Informazioni su farmaci e dispositivi, documenti di studio
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