Comparing Structured Neuromuscular Exercise and Exergaming Program in Adolescents With Familial Mediterranean Fever

NCT ID: NCT07013045

Last Updated: 2025-06-17

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2026-09-01

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.

Conditions

Familial Mediterranean Fever (FMF )

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Structured Neuromuscular Exercise Training Group

In the Structured Neuromuscular Exercise group, the exercise program will be implemented under the supervision of a physiotherapist for 12 weeks, twice a week, in patients diagnosed with FMF.

Group Type: EXPERIMENTAL

Structured Neuromuscular Exercise Group

Intervention Type: OTHER

In the Structured Neuromuscular Exercise group, the exercise program will be administered to patients diagnosed with FMF twice a week for 12 weeks under the supervision of a physiotherapist. The exercises will be performed using a balance board and will include sitting, standing, lunge, modified push-up, and plank positions.

Neuromuscular Exergaming Program Group

In the Neuromuscular Exergaming program, the same exercises included in the Structured Neuromuscular Exercise group will be applied to patients diagnosed with FMF through an exergaming format, under the supervision of a physiotherapist, for 12 weeks, twice a week.

Group Type: EXPERIMENTAL

Neuromuscular Exergaming Program Group

Intervention Type: OTHER

In the Neuromuscular Exergaming group, patients diagnosed with FMF will perform the same exercises as those in the structured neuromuscular exercise program, delivered in an exergaming format using the Smart Exercise Board (SEG-Board). The program will be conducted under the supervision of a physiotherapist, twice weekly for 12 weeks, and will include exercises performed in sitting, standing, lunge, modified push-up, and plank positions.

Interventions

Structured Neuromuscular Exercise Group

In the Structured Neuromuscular Exercise group, the exercise program will be administered to patients diagnosed with FMF twice a week for 12 weeks under the supervision of a physiotherapist. The exercises will be performed using a balance board and will include sitting, standing, lunge, modified push-up, and plank positions.

Intervention Type: OTHER

Neuromuscular Exergaming Program Group

In the Neuromuscular Exergaming group, patients diagnosed with FMF will perform the same exercises as those in the structured neuromuscular exercise program, delivered in an exergaming format using the Smart Exercise Board (SEG-Board). The program will be conducted under the supervision of a physiotherapist, twice weekly for 12 weeks, and will include exercises performed in sitting, standing, lunge, modified push-up, and plank positions.

Intervention Type: OTHER

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: lead

Responsible Party

Asya Albayrak

MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Istanbul University-Cerrahpasa

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

fmfthesis

Identifier Type: -

Identifier Source: org_study_id