Clinical trial NCT06743152: Comparison of the Effects of Synchronous and Asynchronous Telerehabilitation in Patients with Juvenile Familial Mediterranean Fever
Official title: Comparison of the Effects of Synchronous and Asynchronous Telerehabilitation on Fatigue and Functional Capacity in Juvenile Familial Mediterranean Fever Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Familial Mediterranean Fever (FMF )
Exercise
Telerehabilitation
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2024-12-19
Enrollment: 52
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Visuel Analog Scale
timeFrame: From enrollment to the end of treatment at 8 weeks"
measure: Six Minute Walking Test
timeFrame: From enrollment to the end of treatment at 8 weeks
Secondary outcomes:
measure: PedsQL Multidimensional Fatigue Scale
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Fatigue Severity Scale
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: 30 Second Sit-to-Stand Test
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: 10-Step Climbing Test
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Half Squat Test
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Pacer Run Test
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Single Leg Stand Test
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Functional Forward Reach Test
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: K- Force-Kinvent Measurement and Evaluation Set
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Digitsole Pro Smart Insole System
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: FitnessGram Test Battery- Sit-up test
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: FitnessGram Test Battery-The push-up test
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: FitnessGram Test Battery-The Sit-Reach test
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: FitnessGram Test Battery-The trunk lift test
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: FitnessGram Test Battery- body composition
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Visuel Analog Scale
timeFrame: From enrollment to the end of treatment at 8 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
Study officials:
References: