Clinical trial NCT06974942: Physical Activity in Adolescents With Familial Mediterranean Fever
Official title: Investigation of Physical Activity in Adolescents Diagnosed With Familial Mediterranean Fever
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Familial Mediterranean Fever (FMF )
Keywords: Familial Mediterranean Fever
Physical Activity
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 172
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: Inclusion criteria for patients with FMF:

* 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

Exclusion criteria for patients with FMF:

* 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

Inclusion criteria for healthy peers:

* Be between 12-18 years of age
* Be willing to participate in the study

Exclusion criteria for healthy peers:

* 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

Exclusion criteria for removal:

- Leaving at least 3 questions unanswered in the questionnaires

Primary outcomes:
measure: Adolescent Physical Activity Questionnaire (PAQ-A)
timeFrame: Baseline
Secondary outcomes:
measure: Physical Activity Participation Motivation Scale
timeFrame: Baseline
measure: Physical Activity Competence Scale
timeFrame: Baseline
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
Study officials:
References: