MedDataX Logo

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

NCT ID: NCT06743152

Last Updated: 2024-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-29

Study Completion Date

2026-12-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Familial Mediterranean Fever (FMF ) Exercise Telerehabilitation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

synchronous telerehabilitation group

Synchronous telerehabilitation group will be applied a synchronous supervised online exercise program under the supervision of a physiotherapist

Group Type EXPERIMENTAL

Synchronous exercise program

Intervention Type 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 telerehabilitation group

Asynchronous telerehabilitation group will be applied an asynchronous video-based exercise program.

Group Type EXPERIMENTAL

Asynchronous exercise group

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Aysenur Namli

MSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Istanbul University-Cerrahpasa

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ayşenur Namlı Şeker

Role: CONTACT

Phone: +90 212 404 03 00

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Istanbul University-Cerrahpasa Istanbul University-Cerrahpasa

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ANamli

Identifier Type: -

Identifier Source: org_study_id