ClinicalTrials.gov record NCT06743152
Comparison of the Effects of Synchronous and Asynchronous Telerehabilitation in Patients with Juvenile Familial Mediterranean Fever
Comparison of the Effects of Synchronous and Asynchronous Telerehabilitation on Fatigue and Functional Capacity in Juvenile Familial Mediterranean Fever Patients
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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 study enrolls adolescents aged 12–18 who have Familial Mediterranean Fever (FMF). Participants are assigned to either live supervised online exercise sessions via Zoom or an asynchronous video-based program for 8 weeks, twice weekly. The main outcomes measured are fatigue (Visual Analog Scale) and functional capacity (6-Minute Walk Test).
What it is studying. Whether synchronous (live, supervised) telerehabilitation and asynchronous (video-based) telerehabilitation have different effects on fatigue and functional capacity in adolescents with FMF.
What the researchers hope to learn. To compare the effects of synchronous versus asynchronous telerehabilitation on fatigue, functional capacity, pain, balance, physical fitness, and walking in juvenile FMF patients.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
Our study will be randomized controlled. Familial Mediterranean Fever patients between the ages of 12-18 will be included in the study and will be divided into 2 groups. The first group will be applied a synchronous supervised online exercise program under the supervision of a physiotherapist, and the second group will be applied an asynchronous video-based exercise program. The exercise program will be carried out for 8 weeks, 2 days a week. There will be 3 sets, 8 repetitions in 1 set in the exercise program and will be progressed according to tolerance. In the exercise program, the synchronous group will perform the exercises with the supervision of a physiotherapist via the Zoom application, while the asynchronous video-based group will upload the exercises to the system asynchronously via a channel on YouTube that only patients can access. Feedback will be received from the asynchronous group by phone. Our exercise program will be organized with the progression of exercises such as squat, lunge, stepping, running in place and jumping. The primary outcome measures of the study are the evaluation of fatigue (VAS) and functional capacity (6-Minute Walking Test). Our secondary outcome measures are the evaluation of pain, balance, physical fitness and walking. For the assessment of fatigue: Visual Analog Scale (VAS), PedsQL Multidimensional Fatigue Scale, Fatigue Severity Scale; For the assessment of functional capacity: 6 Minute Walk Test, 30 sec Sit-to-Stand Test, 10-Step Climbing Test, Pacer aebonic fitness test, Half Squat Test; For the assessment of balance: One-Leg Stand Test, Functional Forward Reach Test, Kinvent (K-plate)-K Force measurement evaluation set, Digitsole Smart Insole System for the assessment of walking; For the assessment of physical fitness: FitnessGram test battery; For the assessment of pain: VAS will be used.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Behavioral
- Synchronous exercise program
- Asynchronous exercise group
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Being between the ages of 12-18
- The parent's willingness to have their child participate in the study
- Being diagnosed with FMF at least 6 months ago
- Being in an attack-free period
- Have an internet access
- Being able to use a computer, tablet or smartphone
- Have access to a technological device with a camera, microphone and speaker output
- Being willing to participate in the study
Exclusion criteria
- Having any musculoskeletal disease or orthopedic, neurological, psychological disease that may prevent participation in exercise
- Acute pain for any reason
- Development of amyloidosis
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.
Participants are randomly assigned to one of two 8‑week exercise programs (2 sessions per week). One arm does live, supervised online sessions with a physiotherapist via Zoom; the other follows recorded videos on a closed YouTube channel and receives phone feedback. Exercises (squats, lunges, stepping, running in place, jumping) use 3 sets with repetitions progressed by tolerance. Researchers will collect questionnaires and physical tests from enrollment through the end of treatment at 8 weeks, including fatigue scales, the 6‑minute walk and other functional, balance and walking measurements (including a smart insole).
How the study is structured. Randomized, parallel-group interventional study. Participants are randomly assigned to one of two online exercise programs (live supervised sessions or prerecorded video sessions) delivered for 8 weeks, twice per week. Outcomes are assessed from enrollment to the end of the 8-week program.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The registry says recruitment has not started. When is it expected to open, and can I register interest now?
- 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
- Dec 29, 2024 (estimated)
- Primary completion
- Aug 20, 2025 (estimated)
- Study completion
- Dec 29, 2026 (estimated)
- Target enrollment
- 52 participants (estimated)
- Last updated on registry
- Dec 19, 2024
- 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
- Aysenur Namli, MSc
Istanbul University - Cerrahpasa
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Ayşenur Namlı Şeker 📞 +90 212 404 03 00 ✉ fzt.aysenurnamli@gmail.com
Participating sites (1)
- Istanbul University-Cerrahpasa
Istanbul · Turkey (Türkiye)
- Istanbul University-Cerrahpasa Istanbul University-Cerrahpasa · (0212) 404 03 00
Terms used on this page · explanations by MedicalUpdates.ai
- randomized
- Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
- primary outcome
- The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected.
- secondary outcome
- An additional result the study measures alongside the primary outcome, for example quality of life or a laboratory value.
- 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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