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

NCT07013045 | Enrolling By Invitation

• 1 other identifier: fmfthesis
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 )

Keywords

Familial Mediterranean Fever; Neuromuscular exercise; exergame

Outcome Measures

Primary Outcomes (3)

• 10-Stair Climb Test (10-SCT)

  The 10-SCT is commonly used to assess functional capacity in adolescents with chronic rheumatic diseases. During the test, participants will be asked to climb 10 steps (14x28x120 cm) as quickly as possible. The time taken to ascend the stairs will be recorded in seconds using a stopwatch.

  From enrollment to the end of treatment at 12 weeks

• 6-Minute Walk Test (6MWT)

  The 6MWT is a simple, easy-to-administer, and well-tolerated test that reflects the submaximal level of functional capacity. It measures the distance a patient can walk quickly on a hard, flat surface within six minutes. Participants will be instructed on how to perform the test, and the distance walked in six minutes will be recorded in meters. The 6MWT will be used to assess the functional capacity of the participants.

  From enrollment to the end of treatment at 12 weeks

• 30 Second Sit-to-Stand Test

  The 30SST is one of the tests used to assess lower extremity functional strength and performance in adolescents. During the test, participants will sit in the center of an armless chair with a seat height of 45 cm, feet flat on the floor, and arms crossed over their chest. Upon the evaluator's command, they will be instructed to stand up fully and sit back down using both lower limbs, completing as many sit-to-stand-to-sit cycles as possible within 30 seconds. Participants will also be instructed to perform at their maximum effort. The 30SST will be used to evaluate the functional performance of the lower extremities.

  From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (11)

• FitnessGram Physical Activity Test Battery- Curl-up Test

  From enrollment to the end of treatment at 12 weeks

• FitnessGram Physical Activity Test Battery- Push-up Test

  From enrollment to the end of treatment at 12 weeks

• FitnessGram Physical Activity Test Battery- Trunk Lift Test

  From enrollment to the end of treatment at 12 weeks

• FitnessGram Physical Activity Test Battery- Back-Saver Sit and Reach Test

  From enrollment to the end of treatment at 12 weeks

• Progressive Aerobic Cardiovascular Endurance Run (PACER)

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

Structured Neuromuscular Exercise Training Group

EXPERIMENTAL

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.

Other: Structured Neuromuscular Exercise Group

Neuromuscular Exergaming Program Group

EXPERIMENTAL

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.

Other: Neuromuscular Exergaming Program Group

Interventions

Structured Neuromuscular Exercise Group 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.

Structured Neuromuscular Exercise Training Group

Neuromuscular Exergaming Program Group 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.

Neuromuscular Exergaming Program Group

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Familial Mediterranean Fever

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: June 10, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: June 17, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)