Back to resultsDetermination of Exercise Behavior in Patients With Juvenile Idiopathic Arthritis
Primary Purpose
Juvenile Idiopathic Arthritis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Assessing exercise behavior
Sponsored by
About this trial
This is an interventional diagnostic trial for Juvenile Idiopathic Arthritis focused on measuring Juvenile Idiopathic Arthritis, exercise, behavior
Eligibility Criteria
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
Sites / Locations
- Istanbul University-Cerrahpasa
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Assessing exercise behavior
Arm Description
determining exercise behaviour in patients with JIA by using specific scales
Outcomes
Primary Outcome Measures
11-point Numeric Analogue Scale
Exercise Stages of Change Scale-Short Form
Exercise Self-Efficacy Scale
Decisional Balance Scale
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03731520
Brief Title
Determination of Exercise Behavior in Patients With Juvenile Idiopathic Arthritis
Official Title
Determination of Exercise Behavior in Patients With Juvenile Idiopathic Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
April 5, 2018 (Actual)
Primary Completion Date
December 30, 2018 (Actual)
Study Completion Date
January 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Saime Nilay Arman
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juvenile Idiopathic Arthritis
Keywords
Juvenile Idiopathic Arthritis, exercise, behavior
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Assessing exercise behavior
Arm Type
Experimental
Arm Description
determining exercise behaviour in patients with JIA by using specific scales
Intervention Type
Diagnostic Test
Intervention Name(s)
Assessing exercise behavior
Intervention Description
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.
Primary Outcome Measure Information:
Title
11-point Numeric Analogue Scale
Time Frame
baseline
Title
Exercise Stages of Change Scale-Short Form
Time Frame
baseline
Title
Exercise Self-Efficacy Scale
Time Frame
baseline
Title
Decisional Balance Scale
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Istanbul University-Cerrahpasa
City
İstanbul
ZIP/Postal Code
34740
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Determination of Exercise Behavior in Patients With Juvenile Idiopathic Arthritis
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