Familial Mediterranean Fever (FMF )NCT06743152
Comparison of the Effects of Synchronous and Asynchronous Telerehabilitation in Patients with Juvenile Familial Mediterranean Fever
A study testing Synchronous exercise program and Asynchronous exercise group in people with Familial Mediterranean Fever (FMF ) and Exercise, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Familial Mediterranean Fever (FMF ), Exercise, Telerehabilitation
- What is being tested?
- Synchronous exercise program and Asynchronous exercise group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Dec 2024to 29 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Having any musculoskeletal disease or orthopedic, neurological, psychological disease that may prevent participation in exercise
- Acute pain for any reason
- Development of amyloidosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa
Istanbul
Istanbul University-Cerrahpasa Istanbul University-Cerrahpasa, (0212) 404 03 00
About this study
Official title: Comparison of the Effects of Synchronous and Asynchronous Telerehabilitation on Fatigue and Functional Capacity in Juvenile Familial Mediterranean Fever Patients
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.
- Being tested
- Synchronous exercise program, Asynchronous exercise group
- Medical subject headings
- Familial Mediterranean Fever, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synchronous exercise programBehavioural
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 groupBehavioural
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 group | Role | What they receive |
|---|---|---|
| synchronous telerehabilitation group | Experimental | Synchronous telerehabilitation group will be applied a synchronous supervised online exercise program under the supervision of a physiotherapist Receives: Behavioral: Synchronous exercise program |
| Asynchronous telerehabilitation group | Experimental | Asynchronous telerehabilitation group will be applied an asynchronous video-based exercise program. Receives: Behavioral: Asynchronous exercise group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 8 weeks"
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.
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (16)
PedsQL Multidimensional Fatigue Scale
It is a measurement method consisting of 18 questions developed to evaluate fatigue in pediatric patients.
Measured: From enrollment to the end of treatment at 8 weeks
Fatigue Severity Scale
It is a tool consisting of 9 questions that evaluates fatigue severity.
Measured: From enrollment to the end of treatment at 8 weeks
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.
Measured: From enrollment to the end of treatment at 8 weeks
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.
Measured: From enrollment to the end of treatment at 8 weeks
Half Squat Test
Individuals will be asked to maintain a half squat position on a hard surface, feet shoulder-width apart, hands crossed over shoulders, without shoes, in order to assess their functional capacity. The duration of the squat will be recorded in seconds.
Measured: From enrollment to the end of treatment at 8 weeks
Pacer Run Test
They will be asked to run between two cones in a 20-meter corridor, paying attention to the beeps coming from the voice recorder. The test will start at a slow running speed, and the speed will gradually increase every minute. If individuals cannot reach the cone line the first time when the beep sounds, they will be asked to run in the opposite direction. At the end of the test, the total number of completed laps will be taken as the score, including the laps that were not completed.
Measured: From enrollment to the end of treatment at 8 weeks
Single Leg Stand Test
In order to assess the balance of the subjects, they will be asked to stand on one leg with their hands crossed on their chest and the knee joint flexed at 90 degrees. It will be repeated for both the right and left extremities. The test score will be recorded in seconds.
Measured: From enrollment to the end of treatment at 8 weeks
Functional Forward Reach Test
Individuals will be asked to turn sideways to the wall, flex their arm 90 degrees from the shoulder, and make a fist. The third metacarpophalangeal joint will be marked as the starting point and individuals will be asked to reach forward as much as possible without taking a step or bending their knees. The third metacarpophalangeal joint alignment will be marked again at the last point reached. The distance between the two marked points will be recorded in centimeters.
Measured: From enrollment to the end of treatment at 8 weeks
K- Force-Kinvent Measurement and Evaluation Set
Balance skills will be tested during postures such as squat posture on K-Force plates, single leg and double leg postures with eyes open and closed.
Measured: From enrollment to the end of treatment at 8 weeks
Digitsole Pro Smart Insole System
The walking parameters of individuals will be evaluated with the Digitsole Smart Insole system. Digitsole Pro® smart insole is a valid and reliable measurement tool that allows the individual to evaluate the walking parameters of the individual by being placed inside the shoe worn by the participant. Individuals will be asked to walk wearing smart insoles with sensors inside their shoes. The spatio-temporal and kinematic walking parameters of individuals will be evaluated with the Digitsole Pro system.
Measured: From enrollment to the end of treatment at 8 weeks
FitnessGram Test Battery- Sit-up test
The FitnessGram test battery is a valid and reliable measurement method. Its components include functional capacity, flexibility, muscle strength, body composition and muscular endurance. The FitnessGram test battery will include the Sit-up test, Push-up test, Sit-and-reach test, Trunk lift test and Pacer test. The sit-up test will begin with the patient in a supine position with the knees flexed approximately 140 degrees and the knees slightly apart. The patient will be asked to do sit-ups in accordance with the commands from the voice recorder while the arms are extended next to the body, with the shoulder blades slightly lifted off the ground. The number of sit-ups will be recorded.
Measured: From enrollment to the end of treatment at 8 weeks
FitnessGram Test Battery-The push-up test
The push-up test, individuals will be asked to do push-ups in accordance with the commands from the device with the help of elbow flexion and extension while in the prone position. The number of push-ups done correctly will be recorded. The push-up test provides information about the endurance of the upper extremity muscles.
Measured: From enrollment to the end of treatment at 8 weeks
FitnessGram Test Battery-The Sit-Reach test
The Sit-Reach test: A plate with a length of 50 cm and a width of 45 cm is placed on a box with a length of 35 cm, a width of 45 cm and a height of 32 cm. During the test, individuals will reach forward with their hands as far as they can, with one knee in extension and the other knee in flexion in front of the test box. The evaluation will be repeated for the other side. At the end of the test, the distance the individual reaches will be recorded in cm
Measured: From enrollment to the end of treatment at 8 weeks
FitnessGram Test Battery-The trunk lift test
The trunk lift test will be performed to evaluate trunk extensor muscle endurance. The test will begin with the individual's hands placed under the thighs in a prone position on a flat surface. The subjects will be asked to slowly lift their trunks upwards with their heads. At the end of the test, the distance between the ground and the subjects' chin will be recorded in cm.
Measured: From enrollment to the end of treatment at 8 weeks
FitnessGram Test Battery- body composition
Body mass index will be calculated for body composition.
Measured: From enrollment to the end of treatment at 8 weeks
Visuel Analog Scale
Patients will be asked to mark their pain level on a 100 mm line. 0 mm on the line represents "no pain" and 100 mm represents "very severe pain."
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start29 Dec 2024 (estimated)
- Primary completion20 Aug 2025 (estimated)
- Study completion29 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Familial Mediterranean Fever (FMF )Studies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysenur Namli, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06743152
- Sponsor's protocol ID
- ANamli
- Status last verified
- Dec 2024
- First submitted
- 16 Dec 2024
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Synchronous and Asynchronous Telerehabilitation on Fatigue and Functional Capacity in Juvenile Familial Mediterranean Fever Patients
- ClinicalTrials.gov ID
- NCT06743152
- Acronym / sponsor ID
- ANamli
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 29 Dec 2024 (estimated)
- Primary completion
- 20 Aug 2025 (estimated)
- Study completion
- 29 Dec 2026 (estimated)
- First posted
- 19 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| synchronous telerehabilitation group | Experimental | Behavioral: Synchronous exercise programSynchronous telerehabilitation group will be applied a synchronous supervised online exercise program under the supervision of a physiotherapist |
| Asynchronous telerehabilitation group | Experimental | Behavioral: Asynchronous exercise groupAsynchronous telerehabilitation group will be applied an asynchronous video-based exercise program. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- Having any musculoskeletal disease or orthopedic, neurological, psychological disease that may prevent participation in exercise
- Acute pain for any reason
- Development of amyloidosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Synchronous exercise programThe 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. | Behavioural | synchronous telerehabilitation group |
| Asynchronous exercise groupThe 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. | Behavioural | Asynchronous telerehabilitation group |
Primary outcome
Visuel Analog Scale
Time frame: From enrollment to the end of treatment at 8 weeks"
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.
Six Minute Walking Test
Time frame: From enrollment to the end of treatment at 8 weeks
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.
16 secondary outcomes
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
FitnessGram Test Battery-The Sit-Reach test
Time frame: From enrollment to the end of treatment at 8 weeks
FitnessGram Test Battery-The trunk lift test
Time frame: From enrollment to the end of treatment at 8 weeks
FitnessGram Test Battery- body composition
Time frame: From enrollment to the end of treatment at 8 weeks
Visuel Analog Scale
Time frame: From enrollment to the end of treatment at 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synchronous exercise program and Asynchronous exercise group in people with Familial Mediterranean Fever (FMF ) and Exercise, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayşenur Namlı Şeker (+90 212 404 03 00, fzt.aysenurnamli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visuel Analog Scale (time frame: From enrollment to the end of treatment at 8 weeks"). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2024.