Determination of Exercise Behavior in Patients With Juvenile Idiopathic Arthritis

• Sponsor: Saime Nilay Arman (Other)
• Overall Status: Completed
• CT.gov ID: NCT03731520
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arm: 1
• Actual Duration (Months): 9.4
• Patients Per Site Per Month: 10.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Juvenile Idiopathic Arthritis	Diagnostic Test: Assessing exercise behavior	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Determination of Exercise Behavior in Patients With Juvenile Idiopathic Arthritis
• Actual Study Start Date: Apr 5, 2018
• Actual Primary Completion Date: Dec 30, 2018
• Actual Study Completion Date: Jan 15, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Assessing exercise behavior determining exercise behaviour in patients with JIA by using specific scales	Diagnostic Test: Assessing exercise behavior; 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.

Outcome Measures

Primary Outcome Measures

1. 11-point Numeric Analogue Scale [baseline]

2. Exercise Stages of Change Scale-Short Form [baseline]

3. Exercise Self-Efficacy Scale [baseline]

4. Decisional Balance Scale [baseline]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istanbul University-Cerrahpasa	İstanbul		Turkey	34740

Sponsors and Collaborators

• Saime Nilay Arman

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Saime Nilay Arman, Assist.Prof., Istanbul University
• ClinicalTrials.gov Identifier: NCT03731520
• Other Study ID Numbers: IstanbulUC2
• First Posted: Nov 6, 2018
• Last Update Posted: Jul 28, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Saime Nilay Arman, Assist.Prof., Istanbul University: Juvenile Idiopathic Arthritis; exercise; behavior
• Additional relevant MeSH terms: Arthritis; Arthritis, Juvenile

Study Results

No Results Posted as of Jul 28, 2020