Clinical trial NCT07013045: Comparing Structured Neuromuscular Exercise and Exergaming Program in Adolescents With Familial Mediterranean Fever
Official title: Comparison of the Effects of Structured Neuromuscular Exercise Training and Neuromuscular Exergaming Program in Adolescents Diagnosed With Familial Mediterranean Fever
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Familial Mediterranean Fever (FMF )
Keywords: Familial Mediterranean Fever
Neuromuscular exercise
exergame
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Familial Mediterranean Fever (FMF) is an autosomal recessive, autoinflammatory disease characterized by recurrent fever attacks and inflammation of the serous membranes. FMF is defined by short, self-limiting inflammatory attacks that typically resolve within 1-3 days, and classic symptoms during an attack include fever, abdominal pain, chest pain, joint pain, and swelling.

Adolescents with chronic illnesses face numerous challenges in participating in physical activity, and often the disease itself leads to deconditioning and a decline in functional ability. Previous studies have reported that adolescents with FMF have lower cardiorespiratory fitness, exercise capacity, and muscle strength compared to their healthy peers. Even during attack-free periods, children experience high levels of fatigue, lower motivation and activity levels, and problems with concentration.

In the literature, there is evidence that physical activity and exercise programs are safe and feasible in rheumatic diseases such as Juvenile Systemic Lupus Erythematosus, Juvenile Idiopathic Arthritis, Juvenile Fibromyalgia, and Juvenile Dermatomyositis. These programs have been shown to improve patients' functional capacities, physical fitness, and reduce fatigue. However, only one study has been found regarding the effectiveness of physical activity and exercise programs in patients with FMF. This study compared the effectiveness of physical activity counseling and a 12-week online aerobic dance program conducted twice a week. It was found that both interventions led to positive improvements in functional capacity and physical fitness in children and adolescents with FMF, and aerobic dance was found to be feasible in this population. Accordingly, it is evident that further studies comparing the effects of different types of exercise in adolescents with FMF are needed in the literature.

Neuromuscular exercise is defined as a type of training that aims to improve the ability to generate controlled movement through coordinated muscle activation by enhancing various parameters such as muscle strength, flexibility, balance, and agility. Neuromuscular training programs conducted over 6-12 weeks have been shown to positively affect performance-related parameters in adolescent athletes from different sports disciplines, improve motor skills and motor control, enhance balance, proprioception, and core stabilization, reduce injury incidence, and improve both health- and skill-related physical fitness parameters.

Exergaming, derived from the combination of exercise training and video gaming, has gained significant popularity over the past few decades. In the literature, it has been found to improve muscular fitness and physical activity in obese children and adolescents, reduce the perception of fatigue and dyspnea in patients with Cystic Fibrosis, and be a safe option in various conditions with impaired neuromotor control, such as Down Syndrome, Developmental Coordination Disorder, and Cerebral Palsy. However, no study has been found investigating the effectiveness of exergaming in adolescents with FMF.

The aim of our study is to compare the effects of structured neuromuscular exercise training and a neuromuscular exergaming program in adolescents diagnosed with FMF.


Eligibility criteria: Inclusion Criteria:

* Aged between 12 and 18 years
* Diagnosed with FMF at least 6 months ago at the Istanbul Faculty of Medicine, Pediatric Rheumatology Clinic
* Receiving routine medical treatment for FMF
* Being in an attack-free period
* Being willing to participate in the study

Exclusion Criteria:

* Having any chronic systemic disease other than FMF
* Having balance problems of vestibular or neurological origin
* Positive Fukuda (Unterberger) Test
* Having visual or hearing impairments
* Presence of scoliosis, leg length discrepancy, or recent lower extremity surgery
* Development of amyloidosis
* Presence of acute pain due to any cause

Withdrawal Criteria:

* Lack of cooperation with the exercise program
* Missing three consecutive exercise sessions

Primary outcomes:
measure: 10-Stair Climb Test (10-SCT)
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: 6-Minute Walk Test (6MWT)
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: 30 Second Sit-to-Stand Test
timeFrame: From enrollment to the end of treatment at 12 weeks
Secondary outcomes:
measure: FitnessGram Physical Activity Test Battery- Curl-up Test
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: FitnessGram Physical Activity Test Battery- Push-up Test
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: FitnessGram Physical Activity Test Battery- Trunk Lift Test
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: FitnessGram Physical Activity Test Battery- Back-Saver Sit and Reach Test
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Progressive Aerobic Cardiovascular Endurance Run (PACER)
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Kinvent K-Plate Measurement System
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Digitsole Pro® System
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Fatigue Assessment Scale
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Kinvent K-Pull Measurement System
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Physical Activity
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Exercise Satisfaction
timeFrame: From enrollment to the end of treatment at 12 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
Study officials:
References: