CClinicalTrials.gg
Status unknownNCT04724993Updated Jan 26, 2021

Effects of Online Aerobic Exercise Training and Physical Activity Counseling in Juvenile Familial Mediterranean Fever

An interventional study of Online Aerobic Dance Exercises and Physical Activity Counseling in Familial Mediterranean Fever, Exercise and Physical Activity, sponsored by Istanbul University. Status unknown at 1 site in Turkey. Open to participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2021-01-26.

Sponsored by Istanbul University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2021), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
8 Years to 18 Years
Sex
All
01

Study summary

The aim of the study is to investigate comparison the effectiveness of online aerobic dance exercises versus physical activity counselling in patients with Juvenile Familial Mediterranean Fever.

02

Conditions studied

  • Familial Mediterranean Fever
  • Exercise
  • Physical Activity

Keywords

  • Familial Mediterranean Fever
  • Online Exercise
  • Physical Activity Counseling
  • Aerobic Dance
03

Who can participate

Ages eligible
8 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • To be under colchicine treatment for at least 3 months
  • Being in an attack-free period

Exclusion criteria

Exclusion Criteria:

  • Attack in the last 2 weeks
  • Having any systemic chronic disease except Familial Mediterranean Fever
  • Presence of amyloidosis
  • Having arthritis that may prevent participation in exercise
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Online Aerobic Dance Exercises

    In this group, aerobic dance exercises will be applied online under the supervision of a physiotherapist. And participants will record their physical activities on the Physical Activity Tracking Chart.

    Other: Online Aerobic Dance Exercises

  • Experimental
    Physical Activity Counseling

    In this group, participants will be informed online about physical activity and exercise. And they will record their physical activities on the Physical Activity Tracking Chart too.

    Other: Physical Activity Counseling

Interventions

  • OtherOnline Aerobic Dance Exercises

    Online aerobic dance exercises will be performed with observance of physiotherapist. They will record their daily physical activity.

  • OtherPhysical Activity Counseling

    Physical activity and exercise will ve explained to the participants.And they will record their daily physical activity.

05

What researchers measure

Primary outcomes

  1. Six Minute Walk Test

    The 6-minute walk test is a well tolerated, easy-to-apply and a simple test that shows the submaximal level of functional capacity. This test measures the distance that patients can walk quickly on a hard and flat surface within 6 minutes. Patients will be rested in a chair near by the starting position for at least 10 minutes before the test begins. Heart rate, blood plessure, saturation and fatigue levels will be determined by a physiotherapist before and after the test. At the end of the test, the distance walked by the patients within 6 minutes will be recorded in meters.

    Time frame: Change from baseline to 8 weeks

Secondary outcomes

  1. Progressive Aerobic Cardiovascular Endurance Run (PACER)

    PACER is an adaptation of the 20-meter shuttle running test and it is a field test consisting of multiple stages. Participants will run forward and backward in an area of 20 meters, accompanied by music from a tape recorder. The test will start at slow speeds and the speed will gradually increase every minute. The test will be ended when participants cannot continue to run at the level they have reached. The number of laps completed as a result of the test will be recorded.

    Time frame: Change from baseline to 8 weeks

  2. Skinfold Thickness Measurement and Bioelectrical Impedance Analysis

    FitnessGram uses the triceps and calf areas to measure skinfold thickness, as it is easy to measure and is not too invasive. Measurements will be made with a caliper. And participants' body composition will be evaluated with the Tanita Body Analyzer.

    Time frame: Change from baseline to 8 weeks

  3. Curl Up Test

    Abdominal muscle strength and endurance will be evaluated with curl up test. The goal of this test is to do many curl-ups at a specific rhythm as possible. Maximum 75 curl-ups will be counted. At the end of the test, the number of curl-ups will be recorded.

    Time frame: Change from baseline to 8 weeks

  4. Trunk Lift Test

    Trunk extensor muscle strength and flexibility will be evaluated with trunk lift test. Participants will start the test in the prone position. A mark will be placed on the floor at the participants' eye level. During the test, participants raise their torsos slowly and in a controlled manner to a maximum height of 12 inches. At the end of the test, the distance between the floor and the jaws of the participants will be measured and the score will be recorded in cm.

    Time frame: Change from baseline to 8 weeks

  5. Push Up Test

    Upper extremity muscle strength and endurance will be evaluated with push up test.During the test, participants move their torsos towards the ground, when their elbows are bent at 90º, they raise themselves again. The movement is repeated as much as possible. The rhythm is set to 20 push-ups per minute or 1 push-up per 3 seconds. The number of push-ups performed at the end of the test will be recorded.

    Time frame: Change from baseline to 8 weeks

  6. Back saver Sit and Reach Test

    Hamstring muscles' flexibility will be evaluated with back saver sit and reach test. A box is needed for the test. This box is 35 cm long, 45 cm wide, 32 cm high. A 55 cm long and 45 cm wide top plate is placed on the box. One leg of the participants' is completely straight while the other is bent at the knee. Participants reach forward four times by placing their hands on top of each other, holding the fourth access position for 1 second. The distance will be recorded at the end of the test.

    Time frame: Change from baseline to 8 weeks

  7. Physical Activity Questionnaire for Older Children (PAQ-C)

    This scale, developed by Kowalski et al. in 1997, is a 9-item seven-day recall measurement tool designed to evaluate the general physical activity levels of children and adolescents throughout the school year.

    Time frame: Change from baseline to 8 weeks

  8. Physical Activity Questionnaire for Adolescents (PAQ-A)

    This scale, developed by Kowalski et al. in 1997, evaluates the general physical activity level of high school students aged 14-19. It is a measurement tool consisting of 8 items and based on remembering for seven days.

    Time frame: Change from baseline to 8 weeks

  9. PedsQL™ Multidimensional Fatigue Scale

    The PedsQL Multidimensional Fatigue Scale is an 18-question scale developed to assess fatigue in pediatric patients. It evaluates general fatigue, fatigue during sleep/rest, and cognitive fatigue.

    Time frame: Change from baseline to 8 weeks

  10. Familial Mediterranean Fever Quality of Life Scale (FMF-QoL)

    This scale, developed by Ulutatar and Duruoz, is specific to Familial Mediterranean Fever patients and consists of 20 questions that evaluate the quality of life.

    Time frame: Change from baseline to 8 weeks

  11. Visual Analogue Scale for Fatigue

    A 100 mm VAS will be used to evaluate the fatigue of the participants. Scores \<20 mm according to VAS mean "low fatigue", scores between 20-49 mm mean "clinically significant fatigue" and scores with ≥50 mm mean "severe fatigue".

    Time frame: Change from baseline to 8 weeks

  12. Visual Analogue Scale

    It will be used to assess the pain levels of the participants. It is applied by marking with a pencil on a 100 mm horizontal or vertical line. There is no pain at the 0 mm point of this line, and the most severe pain at the 100 mm point.

    Time frame: Change from baseline to 8 weeks

06

Study locations

1 site
  • Istanbul University-Cerrahpasa
    Istanbul, 34740, Turkey
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04724993
Lead sponsor
Istanbul University
Responsible party
Saime Nilay Arman (Assist.Prof., Istanbul University) — Principal investigator
First posted
Jan 26, 2021
Start date
Dec 20, 2020
Primary completion
Feb 2021 (estimated)
Completion
Dec 2021 (estimated)
Last update
Jan 26, 2021

Study contacts

Saime Nilay ARMAN
study director · Istanbul University - Cerrahpasa

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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