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Clinical Trials in Turkey / NCT06743152
Starting soon Not applicable

Comparison of the Effects of Synchronous and Asynchronous Telerehabilitation in Patients with Juvenile Familial Mediterranean Fever

NCT06743152 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2024-12-29
Last updated
2024-12-19

Condition(s) studied

Familial Mediterranean Fever (FMF )ExerciseTelerehabilitation

Investigational drug(s) / intervention(s)

Synchronous exercise programAsynchronous exercise group

Synchronous exercise program: The synchronous exercise group will be conducted online with synchronous supervision under the supervision of a physiotherapist. The exercise program will be performed for 8 weeks, 2 days a week. In the exercise program, 3 sets, 8 repetitions in 1 set will be progressed to 10-12-15-20-25 repetitions according to tolerance. There will be a 1-2 minute rest between sets.

Asynchronous exercise group: The Asynchronous Exercise Group will be conducted with a video-based structured exercise program. For the asynchronous video-based group, a closed channel will be created on Youtube that only patients can access, and the exercises will be uploaded to the system asynchronously. In the asynchronous exercise group, how each exercise is performed will be shown in detail by the physiotherapist in the video content.

Study summary

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.

Eligibility

Sex
ALL
Min age
12 Years
Max age
18 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Istanbul University-Cerrahpasa Istanbul Turkey (Türkiye)

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06743152 on ClinicalTrials.gov ↗ ← All trials in Turkey