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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorIstanbul University - Cerrahpasa

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Having any musculoskeletal disease or orthopedic, neurological, psychological disease that may prevent participation in exercise

Acute pain for any reason

Development of amyloidosis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Synchronous exercise program

    Behavioral

    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

    Behavioral

    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.

Treatment groups

52 Participants
are divided into 2 treatment groups
Group A: synchronous telerehabilitation groupExperimental treatment 1 intervention
Group B: Asynchronous telerehabilitation groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Visuel Analog Scale

In the evaluation of patient fatigue, patients will be asked to mark on a 100 mm horizontal line. According to VAS, a 0 mm point on this line indicates no fatigue, while a 100 mm point indicates very severe fatigue.

Time frame
From enrollment to the end of treatment at 8 weeks"
2

Six Minute Walking Test

It is a test frequently used to evaluate functional capacity. The distance that patients walk in a 30-meter corridor on a flat surface for 6 minutes will be recorded.

Time frame
From enrollment to the end of treatment at 8 weeks

Secondary outcomes

1

PedsQL Multidimensional Fatigue Scale

It is a measurement method consisting of 18 questions developed to evaluate fatigue in pediatric patients.

Time frame
From enrollment to the end of treatment at 8 weeks
2

Fatigue Severity Scale

It is a tool consisting of 9 questions that evaluates fatigue severity.

Time frame
From enrollment to the end of treatment at 8 weeks
3

30 Second Sit-to-Stand Test

One of the tests that will be used to test the functional capacity of individuals is the 30-second sit-to-stand test. During the test, patients will be asked to sit with their hands crossed over their shoulders and their feet touching the ground, and to do a full sit-to-stand in this position. The number of correct standing ups within thirty seconds will be recorded as the test score.

Time frame
From enrollment to the end of treatment at 8 weeks
4

10-Step Climbing Test

In order to evaluate the functional capacity of the patients, they will be asked to quickly climb up and down 10 stairs and the test score will be recorded in seconds.

Time frame
From enrollment to the end of treatment at 8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: