Physical Activity in Adolescents With Familial Mediterranean Fever

NCT06974942 | Not Yet Recruiting

• 1 other identifier: paqfmf
• Study Type: observational
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

Familial Mediterranean Fever (FMF) is one of the most common autoinflammatory rheumatic diseases in childhood. Problems such as joint pain, muscle weakness, decreased aerobic capacity, and fatigue seen in children and adolescents with rheumatic disease may lead to low physical fitness levels. Limitation of physical performance is one of the possible consequences of chronic diseases that occur during childhood. At the same time, children with chronic illness face many challenges in participating in physical activity. Pediatric patients with rheumatic diseases tend to be physically inactive and, compared to their healthy peers, generally avoid participating in physical activity due to the limitations imposed by the disease. Often, the disease itself paves the way for decreased functional capacity and the development of deconditioning. Therefore, prescribing physical activity and exercise to pediatric populations with chronic illnesses is of great importance. This approach helps alleviate both the symptoms related to chronic diseases and the lifelong complications secondary to pharmacological treatments, and also prevents the development of new chronic conditions. Participation in adequate physical activity is one of the most important behaviors individuals can adopt to maintain their health and well-being. Globally, public health physical activity guidelines address the exercise needs of children and adolescents. The European Alliance of Associations for Rheumatology (EULAR) highlights in its physical activity and exercise guidelines for patients with rheumatic diseases that the physical activity recommendations made for the general population are also applicable to patients with rheumatic diseases. With this cohort study, it is aimed to examine physical activity (PA) in detail in adolescents diagnosed with FMF and to compare them with healthy peers. This study is one of the first in our country to provide comprehensive data on the PA levels of adolescents with FMF. The findings obtained will contribute to understanding PA levels and exercise perception, and guide the planning of exercise programs to be developed for these individuals. Moreover, the results of the study may also serve as a basis for future research in children and adolescents with various chronic diseases, especially those with FMF.

Conditions

Familial Mediterranean Fever (FMF )

Keywords

Familial Mediterranean Fever; Physical Activity

Outcome Measures

Primary Outcomes (1)

• Adolescent Physical Activity Questionnaire (PAQ-A)

  The Adolescent Physical Activity Questionnaire, developed by Kowalski and colleagues in 1997 to assess the physical activity levels of high school students, is an 8-item, 5-point Likert scale tool based on recalling the past 7 days. The 8 items in the scale are used to calculate the physical activity score. The 9th item inquires whether the participant was ill during the past week or if there was any condition preventing normal physical activity. However, this item is not included in the scoring. The first item lists 24 types of physical activity. The frequency of each activity is scored as "never" (1 point), "1-2" (2 points), "3-4" (3 points), "5-6" (4 points), or "7 or more times" (5 points). The result is divided by 24 to obtain the activity score for this item. For items 2-7, responses start with the lowest level of physical activity (1 point) and increase to the highest level (5 points). Item 8 evaluates the frequency of physical activity over the 7 days of the week. Responses a

  Baseline

Secondary Outcomes (2)

• Physical Activity Participation Motivation Scale

  Baseline

• Physical Activity Competence Scale

  Baseline

Study Arms (2)

Familial Mediterranean Fever

The study will include 76 patients diagnosed with Familial Mediterranean Fever who are being followed at the Division of Pediatric Rheumatology, Department of Pediatrics, Istanbul Faculty of Medicine, Istanbul University.

Healthy control

The study will include healthy peers of adolescents diagnosed with FMF.

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Our study consists of two cohorts, where the physical activity level, physical activity competence, and motivation for physical activity of adolescents with Familial Mediterranean Fever (FMF) will be evaluated and compared with their healthy peers.

You may qualify if:

• Be between 12-18 years of age
• Have been diagnosed with FMF for at least 6 months at the Pediatric Rheumatology Department of Istanbul Faculty of Medicine
• Be undergoing routine medical treatment for FMF
• Be willing to participate in the study

You may not qualify if:

• Adolescents whose participation in the study is not wanted by their family
• Having vestibular or neurological balance problems
• Presence of scoliosis, leg length discrepancy, or recent lower extremity surgery
• Adolescents with visual or hearing impairments
• Be between 12-18 years of age
• Be willing to participate in the study
• Adolescents whose participation in the study is not wanted by their family
• Having vestibular or neurological balance problems
• Presence of scoliosis, leg length discrepancy, or recent lower extremity surgery
• Adolescents with visual or hearing impairments
• \- Leaving at least 3 questions unanswered in the questionnaires

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Familial Mediterranean Fever; Motor Activity

Condition Hierarchy (Ancestors)

Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior

Central Study Contacts

Nilay Arman, PhD

CONTACT

0553 455 87 07; nilayarman@iuc.edu.tr

Asya Albayrak, MSc

CONTACT

0538 396 89 50

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 16, 2025
• Study Start: May 15, 2025
• Primary Completion: August 15, 2025
• Study Completion: November 15, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)