Effects of Online Aerobic Exercise Training and Physical Activity Counseling in Juvenile Familial Mediterranean Fever
Primary Purpose
Familial Mediterranean Fever, Exercise, Physical Activity
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Online Aerobic Dance Exercises
Physical Activity Counseling
Sponsored by
About this trial
This is an interventional treatment trial for Familial Mediterranean Fever focused on measuring Familial Mediterranean Fever, Online Exercise, Physical Activity Counseling, Aerobic Dance
Eligibility Criteria
Inclusion Criteria:
- To be under colchicine treatment for at least 3 months
- Being in an attack-free period
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
Sites / Locations
- Istanbul University-Cerrahpasa
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Online Aerobic Dance Exercises
Physical Activity Counseling
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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".
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04724993
Brief Title
Effects of Online Aerobic Exercise Training and Physical Activity Counseling in Juvenile Familial Mediterranean Fever
Official Title
Comparison the Effectiveness of Online Aerobic Dance Exercises Versus Physical Activity Counseling in Patients With Juvenile Familial Mediterranean Fever
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 20, 2020 (Actual)
Primary Completion Date
February 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Familial Mediterranean Fever, Exercise, Physical Activity
Keywords
Familial Mediterranean Fever, Online Exercise, Physical Activity Counseling, Aerobic Dance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Online Aerobic Dance Exercises
Arm Type
Experimental
Arm Description
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.
Arm Title
Physical Activity Counseling
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Online Aerobic Dance Exercises
Intervention Description
Online aerobic dance exercises will be performed with observance of physiotherapist. They will record their daily physical activity.
Intervention Type
Other
Intervention Name(s)
Physical Activity Counseling
Intervention Description
Physical activity and exercise will ve explained to the participants.And they will record their daily physical activity.
Primary Outcome Measure Information:
Title
Six Minute Walk Test
Description
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 Outcome Measure Information:
Title
Progressive Aerobic Cardiovascular Endurance Run (PACER)
Description
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
Title
Skinfold Thickness Measurement and Bioelectrical Impedance Analysis
Description
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
Title
Curl Up Test
Description
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
Title
Trunk Lift Test
Description
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
Title
Push Up Test
Description
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
Title
Back saver Sit and Reach Test
Description
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
Title
Physical Activity Questionnaire for Older Children (PAQ-C)
Description
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
Title
Physical Activity Questionnaire for Adolescents (PAQ-A)
Description
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
Title
PedsQL™ Multidimensional Fatigue Scale
Description
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
Title
Familial Mediterranean Fever Quality of Life Scale (FMF-QoL)
Description
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
Title
Visual Analogue Scale for Fatigue
Description
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
Title
Visual Analogue Scale
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
To be under colchicine treatment for at least 3 months
Being in an attack-free period
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saime Nilay ARMAN
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul University-Cerrahpasa
City
Istanbul
ZIP/Postal Code
34740
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Online Aerobic Exercise Training and Physical Activity Counseling in Juvenile Familial Mediterranean Fever
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