- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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.
Przegląd badań
Status
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Nilay Arman, Associate Professor
- Numer telefonu: +90 +90 (553) 455 87 07
- E-mail: nilayarman@iuc.edu.tr
Kopia zapasowa kontaktu do badania
- Nazwa: Beyza N Yumak, MSc
- Numer telefonu: +90 +90 (539) 856 14 70
- E-mail: beyzanurymk@gmail.com
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
|---|
|
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).
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Self-Perceived Health-Related Physical Fitness Questionnaire
Ramy czasowe: 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
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
FitnessGram Test Battery
Ramy czasowe: 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
|
Współpracownicy i badacze
Sponsor
Śledczy
- Krzesło do nauki: Nilay Arman, Associate Professor, Istanbul University - Cerrahpasa
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Choroby układu mięśniowo-szkieletowego
- Artretyzm
- Choroby stawów
- Choroby reumatyczne
- Choroby genetyczne, wrodzone
- Choroby tkanki łącznej
- Choroby Autoimmunologiczne
- Choroby układu odpornościowego
- Dziedziczne choroby autozapalne
- Wrodzone, dziedziczne i noworodkowe choroby i nieprawidłowości
- Choroby skóry i tkanki łącznej
- Zapalenie stawów, młodzieńcze
- Rodzinna gorączka śródziemnomorska
Inne numery identyfikacyjne badania
- hXEd9X7x
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .