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

January 22, 2021 updated by: Saime Nilay Arman, Istanbul University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34740
        • Istanbul University-Cerrahpasa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Online aerobic dance exercises will be performed with observance of physiotherapist. They will record their daily physical activity.
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
Physical activity and exercise will ve explained to the participants.And they will record their daily physical activity.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Change from baseline to 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progressive Aerobic Cardiovascular Endurance Run (PACER)
Time Frame: Change from baseline to 8 weeks
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.
Change from baseline to 8 weeks
Skinfold Thickness Measurement and Bioelectrical Impedance Analysis
Time Frame: Change from baseline to 8 weeks
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.
Change from baseline to 8 weeks
Curl Up Test
Time Frame: Change from baseline to 8 weeks
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.
Change from baseline to 8 weeks
Trunk Lift Test
Time Frame: Change from baseline to 8 weeks
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.
Change from baseline to 8 weeks
Push Up Test
Time Frame: Change from baseline to 8 weeks
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.
Change from baseline to 8 weeks
Back saver Sit and Reach Test
Time Frame: Change from baseline to 8 weeks
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.
Change from baseline to 8 weeks
Physical Activity Questionnaire for Older Children (PAQ-C)
Time Frame: Change from baseline to 8 weeks
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.
Change from baseline to 8 weeks
Physical Activity Questionnaire for Adolescents (PAQ-A)
Time Frame: Change from baseline to 8 weeks
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.
Change from baseline to 8 weeks
PedsQL™ Multidimensional Fatigue Scale
Time Frame: Change from baseline to 8 weeks
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.
Change from baseline to 8 weeks
Familial Mediterranean Fever Quality of Life Scale (FMF-QoL)
Time Frame: Change from baseline to 8 weeks
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.
Change from baseline to 8 weeks
Visual Analogue Scale for Fatigue
Time Frame: Change from baseline to 8 weeks
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".
Change from baseline to 8 weeks
Visual Analogue Scale
Time Frame: Change from baseline to 8 weeks
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.
Change from baseline to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Saime Nilay ARMAN, Istanbul University - Cerrahpasa (IUC)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 20, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 26, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 05/12/2019-186585

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Physical Activity

Clinical Trials on Online Aerobic Dance Exercises

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings