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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

29 maggio 2026 aggiornato da: Beyza Nur Yumak, Istanbul University - Cerrahpasa

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

Non ancora reclutamento

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

Osservativo

Iscrizione (Stimato)

100

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

It is generally recommended that the sample size for validity and reliability studies be 5 to 10 times the total number of items (30). In light of this information in the literature, and given that the International Physical Fitness Questionnaire (IPFQ) and the Self-Perceived Health-Related Physical Fitness Questionnaire for Children (SPFQ-C) have a total of 14 items, the sample size for our study was determined to be 98 participants. Consequently, we plan to include a minimum of 100 patients diagnosed with JIA or FMF in our study. Participants will be recruited from individuals who are being followed up at the Pediatric Rheumatology Subdivision of the Department of Internal Medical Sciences at Istanbul University Faculty of Medicine and who meet the inclusion criteria.

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

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
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).

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Self-Perceived Health-Related Physical Fitness Questionnaire
Lasso di tempo: 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.
Until one week after registration
International Fitness Scale
Lasso di tempo: 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).
Until one week after the registration date

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
FitnessGram Test Battery
Lasso di tempo: 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

Until one week after registration

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Cattedra di studio: Nilay Arman, Associate Professor, Istanbul University - Cerrahpasa

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

30 ottobre 2026

Completamento dello studio (Stimato)

30 ottobre 2026

Date di iscrizione allo studio

Primo inviato

27 novembre 2025

Primo inviato che soddisfa i criteri di controllo qualità

29 maggio 2026

Primo Inserito (Effettivo)

1 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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