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Determination of Exercise Behavior in Patients With Juvenile Idiopathic Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03731520
Recruitment Status : Active, not recruiting
First Posted : November 6, 2018
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Saime Nilay Arman, Istanbul University

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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 : April 5, 2018
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : January 15, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 11-point Numeric Analogue Scale [ Time Frame: baseline ]
  2. Exercise Stages of Change Scale-Short Form [ Time Frame: baseline ]
  3. Exercise Self-Efficacy Scale [ Time Frame: baseline ]
  4. Decisional Balance Scale [ Time Frame: baseline ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03731520


Locations
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Turkey
Istanbul University-Cerrahpasa
İstanbul, Turkey, 34740
Sponsors and Collaborators
Saime Nilay Arman

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Responsible Party: Saime Nilay Arman, Assist.Prof., Istanbul University
ClinicalTrials.gov Identifier: NCT03731520    
Other Study ID Numbers: IstanbulUC2
First Posted: November 6, 2018    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Saime Nilay Arman, Istanbul University:
Juvenile Idiopathic Arthritis
exercise
behavior
Additional relevant MeSH terms:
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Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases