Familial Mediterranean FeverNCT04724993
Effects of Online Aerobic Exercise Training and Physical Activity Counseling in Juvenile Familial Mediterranean Fever
A study testing Online Aerobic Dance Exercises and Physical Activity Counseling in people with Familial Mediterranean Fever and Exercise, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Familial Mediterranean Fever, Exercise, Physical Activity
- What is being tested?
- Online Aerobic Dance Exercises and Physical Activity Counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Dec 2020to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- To be under colchicine treatment for at least 3 months
- Being in an attack-free period
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa
Istanbul, 34740
About this study
Official title: Comparison the Effectiveness of Online Aerobic Dance Exercises Versus Physical Activity Counseling in Patients With Juvenile Familial Mediterranean Fever
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.
- Conditions
- Familial Mediterranean Fever, Exercise, Physical Activity
- Being tested
- Online Aerobic Dance Exercises, Physical Activity Counseling
- Keywords
- Familial Mediterranean Fever, Online Exercise, Physical Activity Counseling, Aerobic Dance
- 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.
Online Aerobic Dance ExercisesOther
Online aerobic dance exercises will be performed with observance of physiotherapist. They will record their daily physical activity.
Physical Activity CounselingOther
Physical activity and exercise will ve explained to the participants.And they will record their daily physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Online Aerobic Dance Exercises | Experimental | 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. Receives: Other: Online Aerobic Dance Exercises |
| Physical Activity Counseling | Experimental | 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. Receives: Other: Physical Activity Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to 8 weeks
Secondary outcomes (12)
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.
Measured: Change from baseline to 8 weeks
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.
Measured: Change from baseline to 8 weeks
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.
Measured: Change from baseline to 8 weeks
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.
Measured: Change from baseline to 8 weeks
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.
Measured: Change from baseline to 8 weeks
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.
Measured: Change from baseline to 8 weeks
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.
Measured: Change from baseline to 8 weeks
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.
Measured: Change from baseline to 8 weeks
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.
Measured: Change from baseline to 8 weeks
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.
Measured: Change from baseline to 8 weeks
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".
Measured: Change from baseline to 8 weeks
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.
Measured: Change from baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start20 Dec 2020
- Primary completionFeb 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Familial Mediterranean FeverStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saime Nilay Arman, Istanbul University
- Investigators
- Saime Nilay ARMAN, Study director, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04724993
- Sponsor's protocol ID
- 05/12/2019-186585
- Status last verified
- Jan 2021
- First submitted
- 22 Jan 2021
- Last updated
- 26 Jan 2021
- 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 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison the Effectiveness of Online Aerobic Dance Exercises Versus Physical Activity Counseling in Patients With Juvenile Familial Mediterranean Fever
- ClinicalTrials.gov ID
- NCT04724993
- Acronym / sponsor ID
- 05/12/2019-186585
- Conditions
- Familial Mediterranean Fever, Exercise, Physical Activity
- Keywords
- Familial Mediterranean Fever, Online Exercise, Physical Activity Counseling, Aerobic Dance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 20 Dec 2020 (actual)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 26 Jan 2021 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online Aerobic Dance Exercises | Experimental | Other: Online Aerobic Dance ExercisesIn 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. |
| Physical Activity Counseling | Experimental | Other: Physical Activity CounselingIn 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. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- To be under colchicine treatment for at least 3 months
- Being in an attack-free period
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Online Aerobic Dance ExercisesOnline aerobic dance exercises will be performed with observance of physiotherapist. They will record their daily physical activity. | Other | Online Aerobic Dance Exercises |
| Physical Activity CounselingPhysical activity and exercise will ve explained to the participants.And they will record their daily physical activity. | Other | Physical Activity Counseling |
Primary outcome
Six Minute Walk Test
Time frame: Change from baseline to 8 weeks
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.
12 secondary outcomes
Progressive Aerobic Cardiovascular Endurance Run (PACER)
Time frame: Change from baseline to 8 weeks
Skinfold Thickness Measurement and Bioelectrical Impedance Analysis
Time frame: Change from baseline to 8 weeks
Curl Up Test
Time frame: Change from baseline to 8 weeks
Trunk Lift Test
Time frame: Change from baseline to 8 weeks
Push Up Test
Time frame: Change from baseline to 8 weeks
Back saver Sit and Reach Test
Time frame: Change from baseline to 8 weeks
Physical Activity Questionnaire for Older Children (PAQ-C)
Time frame: Change from baseline to 8 weeks
Physical Activity Questionnaire for Adolescents (PAQ-A)
Time frame: Change from baseline to 8 weeks
PedsQL™ Multidimensional Fatigue Scale
Time frame: Change from baseline to 8 weeks
Familial Mediterranean Fever Quality of Life Scale (FMF-QoL)
Time frame: Change from baseline to 8 weeks
Visual Analogue Scale for Fatigue
Time frame: Change from baseline to 8 weeks
Visual Analogue Scale
Time frame: Change from baseline to 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- Individual participant dataSharing planned: No
Related trials for Familial Mediterranean Fever
RecruitingObservational study
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Not yet recruitingPhase 3
Goflikicept for Resolution and Prevention of Attacks in Pediatric and Adolescent Patients With Colchicine-Resistant or Colchicine-Intolerant Familial Mediterranean Fever
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Genotype and Phenotype in Pediatric Familial Mediterranean Fever
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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. This study is not recruiting at the moment.
Saime Nilay ARMAN study director
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Aerobic Dance Exercises and Physical Activity Counseling in people with Familial Mediterranean Fever and Exercise, run by Istanbul University 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 26 Jan 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six Minute Walk Test (time frame: Change from baseline to 8 weeks). 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 26 Jan 2021.