NCT04724993

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 20, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 22, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 26, 2021

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

January 26, 2021

Status Verified

January 1, 2021

Enrollment Period

1 month

First QC Date

January 22, 2021

Last Update Submit

January 22, 2021

Conditions

Familial Mediterranean FeverExercisePhysical Activity

Keywords

Familial Mediterranean FeverOnline ExercisePhysical Activity CounselingAerobic Dance

Outcome Measures

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.

    Change from baseline to 8 weeks

Secondary Outcomes (12)

  • Progressive Aerobic Cardiovascular Endurance Run (PACER)

    Change from baseline to 8 weeks

  • Skinfold Thickness Measurement and Bioelectrical Impedance Analysis

    Change from baseline to 8 weeks

  • Curl Up Test

    Change from baseline to 8 weeks

  • Trunk Lift Test

    Change from baseline to 8 weeks

  • Push Up Test

    Change from baseline to 8 weeks

  • +7 more secondary outcomes

Study Arms (2)

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.

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.

Other: Physical Activity Counseling

Interventions

Online Aerobic Dance ExercisesOTHER

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

Online Aerobic Dance Exercises
Physical Activity CounselingOTHER

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

Physical Activity Counseling

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, 34740, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Familial Mediterranean FeverMotor Activity

Condition Hierarchy (Ancestors)

Hereditary Autoinflammatory DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBehavior

Study Officials

  • Saime Nilay ARMAN

    Istanbul University - Cerrahpasa

    STUDY DIRECTOR

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
Assist.Prof.

Study Record Dates

First Submitted

January 22, 2021

First Posted

January 26, 2021

Study Start

December 20, 2020

Primary Completion

February 1, 2021

Study Completion

December 1, 2021

Last Updated

January 26, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)