- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03731520
Determination of Exercise Behavior in Patients With Juvenile Idiopathic Arthritis
July 27, 2020 updated by: Saime Nilay Arman
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
100
Phase
- 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
-
-
-
İstanbul, Turkey, 34740
- Istanbul University-Cerrahpaşa
-
-
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
Ages Eligible for Study
6 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosed as JIA according to ILAR classification
- Aged between 6-18
- Adequate cognitive function for understanding questions
Exclusion Criteria:
- a parent who does not have a smartphone
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: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Assessing exercise behavior
determining exercise behaviour in patients with JIA by using specific scales
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
11-point Numeric Analogue Scale
Time Frame: baseline
|
baseline
|
|
Exercise Stages of Change Scale-Short Form
Time Frame: baseline
|
baseline
|
|
Exercise Self-Efficacy Scale
Time Frame: baseline
|
baseline
|
|
Decisional Balance Scale
Time Frame: baseline
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
April 5, 2018
Primary Completion (Actual)
December 30, 2018
Study Completion (Actual)
January 15, 2019
Study Registration Dates
First Submitted
November 3, 2018
First Submitted That Met QC Criteria
November 3, 2018
First Posted (Actual)
November 6, 2018
Study Record Updates
Last Update Posted (Actual)
July 28, 2020
Last Update Submitted That Met QC Criteria
July 27, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IstanbulUC2
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.