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

NCT06743152 | Not Yet Recruiting

• 1 other identifier: ANamli
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Familial Mediterranean Fever (FMF ); Exercise; Telerehabilitation

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (16)

• PedsQL Multidimensional Fatigue Scale

  From enrollment to the end of treatment at 8 weeks

• Fatigue Severity Scale

  From enrollment to the end of treatment at 8 weeks

• 30 Second Sit-to-Stand Test

  From enrollment to the end of treatment at 8 weeks

• 10-Step Climbing Test

  From enrollment to the end of treatment at 8 weeks

• Half Squat Test

  From enrollment to the end of treatment at 8 weeks

Study Arms (2)

synchronous telerehabilitation group

EXPERIMENTAL

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

Behavioral: Synchronous exercise program

Asynchronous telerehabilitation group

EXPERIMENTAL

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

Behavioral: Asynchronous exercise group

Interventions

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.

synchronous telerehabilitation group

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.

Asynchronous telerehabilitation group

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Having any musculoskeletal disease or orthopedic, neurological, psychological disease that may prevent participation in exercise
• Acute pain for any reason
• Development of amyloidosis

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Familial Mediterranean Fever; Motor Activity

Condition Hierarchy (Ancestors)

Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior

Central Study Contacts

Ayşenur Namlı Şeker

CONTACT

+90 212 404 03 00; fzt.aysenurnamli@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 19, 2024
• Study Start: December 29, 2024
• Primary Completion: August 20, 2025
• Study Completion (Estimated): December 29, 2026
• Last Updated: December 19, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)