Comparison of the Effects of Synchronous and Asynchronous Telerehabilitation in Patients with Juvenile Familial Mediterranean Fever
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Synchronous exercise program, Asynchronous exercise group.
- Who it may be relevant to
- Registry conditions: Familial Mediterranean Fever (FMF ), Exercise, Telerehabilitation. Basic parameters: 12 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of the Effects of Synchronous and Asynchronous Telerehabilitation on Fatigue and Functional Capacity in Juvenile Familial Mediterranean Fever Patients
Overview
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
- Behavioral 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. - Behavioral 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.
Primary outcome measures
- Visuel Analog Scale [Time frame: From enrollment to the end of treatment at 8 weeks"]
- Six Minute Walking Test [Time frame: From enrollment to the end of treatment at 8 weeks]
Secondary outcome measures (12)
- PedsQL Multidimensional Fatigue Scale [Time frame: From enrollment to the end of treatment at 8 weeks]
- Fatigue Severity Scale [Time frame: From enrollment to the end of treatment at 8 weeks]
- 30 Second Sit-to-Stand Test [Time frame: From enrollment to the end of treatment at 8 weeks]
- 10-Step Climbing Test [Time frame: From enrollment to the end of treatment at 8 weeks]
- Half Squat Test [Time frame: From enrollment to the end of treatment at 8 weeks]
- Pacer Run Test [Time frame: From enrollment to the end of treatment at 8 weeks]
- Single Leg Stand Test [Time frame: From enrollment to the end of treatment at 8 weeks]
- Functional Forward Reach Test [Time frame: From enrollment to the end of treatment at 8 weeks]
- K- Force-Kinvent Measurement and Evaluation Set [Time frame: From enrollment to the end of treatment at 8 weeks]
- Digitsole Pro Smart Insole System [Time frame: From enrollment to the end of treatment at 8 weeks]
- FitnessGram Test Battery- Sit-up test [Time frame: From enrollment to the end of treatment at 8 weeks]
- FitnessGram Test Battery-The push-up test [Time frame: From enrollment to the end of treatment at 8 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Istanbul University-Cerrahpasa — Istanbul
Identifiers
NCT: NCT06743152 · ANamli