NCT03731520

Brief Summary

Juvenile idiopathic arthritis (JIA) is one of the most common rheumatic diseases in childhood, affecting at least 1 in 1000 children. Children with JIA experience joint inflammation and swelling, pain and tenderness, morning stiffness, limited mobility. Children with JIA complain pain and have lower functional ability and decreased quality of life compared with their peers. Many studies have reported that patients with JIA have low physical activity levels and also exercise therapy is considered an important component of the treatment of JIA. Nowadays, studies for evaluating exercise behaviours in order to cope with physical inactivity for many chronic diseases are becoming increasingly important.The objective of this study is to determine exercise behaviour in patients with JIA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

April 5, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 6, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2019

Completed
Last Updated

July 28, 2020

Status Verified

July 1, 2020

Enrollment Period

9 months

First QC Date

November 3, 2018

Last Update Submit

July 27, 2020

Conditions

Keywords

Juvenile Idiopathic Arthritisexercisebehavior

Outcome Measures

Primary Outcomes (4)

  • 11-point Numeric Analogue Scale

    baseline

  • Exercise Stages of Change Scale-Short Form

    baseline

  • Exercise Self-Efficacy Scale

    baseline

  • Decisional Balance Scale

    baseline

Study Arms (1)

Assessing exercise behavior

EXPERIMENTAL

determining exercise behaviour in patients with JIA by using specific scales

Diagnostic Test: Assessing exercise behavior

Interventions

11-point Numeric Analogue Scale (NRS) for satisfaction of exercising, Exercise Stages of Change Scale-Short Form (ESCS), Exercise Self-Efficacy Scale (ESES), and Decisional Balance Scale (DBS) for exercise behaviour will be inquired for the patients with JIA.

Assessing exercise behavior

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Diagnosed as JIA according to ILAR classification
  • Aged between 6-18
  • Adequate cognitive function for understanding questions

You may not qualify if:

  • \- a parent who does not have a smartphone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, 34740, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Arthritis, JuvenileMotor ActivityBehavior

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assist.Prof.

Study Record Dates

First Submitted

November 3, 2018

First Posted

November 6, 2018

Study Start

April 5, 2018

Primary Completion

December 30, 2018

Study Completion

January 15, 2019

Last Updated

July 28, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations