ClinicalTrials.gov record NCT07013045

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Comparison of the Effects of Structured Neuromuscular Exercise Training and Neuromuscular Exergaming Program in Adolescents Diagnosed With Familial Mediterranean Fever

StatusEnrolling by invitationThe study enrols only people the study team invites, for example patients already at a particular clinic. It is not open to the public.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
Age12 years old to 18 years old
SexAll
LocationTurkey
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This randomized interventional study compares two supervised 12-week exercise programs for adolescents with familial Mediterranean fever (FMF). One program is structured neuromuscular training; the other delivers the same exercises through an exergaming format using a Smart Exercise Board. Participants attend supervised sessions twice weekly and have fitness, strength, balance, gait and fatigue assessments before and after the program.

What it is studying. The study tests whether the effects on functional capacity, muscle strength and endurance, balance, gait, physical activity levels and fatigue differ between a structured neuromuscular training program and the same program delivered via exergaming in adolescents with FMF.

What the researchers hope to learn. To compare the effects of structured neuromuscular exercise training versus a neuromuscular exergaming program on functional capacity, muscle strength and endurance, balance, gait, physical activity and fatigue in adolescents with FMF.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Other
  • Structured Neuromuscular Exercise Group
  • Neuromuscular Exergaming Program Group

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Take part in supervised exercise sessions twice a week for 12 weeks led by a physiotherapist, doing neuromuscular exercises (sitting, standing, lunge, modified push-up, plank) either on a balance board or via an exergaming Smart Exercise Board. Complete physical performance tests before and after the 12-week program (for example a stair-climb, 6-minute walk, sit-to-stand, FitnessGram tests, PACER) and balance/strength and gait measurements using devices listed in the study. Wear a smartwatch so step counts/physical activity can be recorded for about three months, complete a fatigue questionnaire, and rate exercise satisfaction. Participants who miss three consecutive sessions or do not cooperate with the program may be withdrawn from the study.

How the study is structured. This is a randomized, open-label trial in which participants are assigned to one of two supervised exercise programs. Both programs run twice weekly for 12 weeks and are overseen by a physiotherapist. Assessments are done at enrollment and after the 12-week program and include timed walking and stair tests, sit-to-stand and other fitness tests, balance and gait measurements, activity monitoring with a smartwatch, and fatigue questionnaires.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry says participants are enrolled by invitation. Who decides who is invited, and how?
  • The listed sites are in Turkey. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on familial Mediterranean fever

Important dates

Study start
Jun 1, 2025
Primary completion
Jun 1, 2026 (estimated)
Study completion
Sep 1, 2026 (estimated)
Target enrollment
60 participants (estimated)
Last updated on registry
Jun 17, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Istanbul University - Cerrahpasa
Principal investigator
Asya Albayrak, MSc
Istanbul University - Cerrahpasa

Participating sites (1)

  • Istanbul University-Cerrahpasa

    Istanbul · Turkey (Türkiye)

Terms used on this page · explanations by MedicalUpdates.ai

Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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