- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06609837
30-Second Sit-to-Stand Test for Assessing Functional Capacity in Juvenile Idiopathic Arthritis
30-Second Sit-to-Stand Test as an Alternative Tool for Assessing Functional Capacity in Patients With Juvenile Idiopathic Arthritis
Juvenile Idiopathic Arthritis (JIA) is a heterogeneous, idiopathic, chronic inflammatory, rheumatic disease that is most common in childhood and is thought to involve immunological mechanisms in its etiopathogenesis. The physiology of children and adolescents is constantly changing due to the development and maturation of their systems. At the same time, the changes that this population shows, especially during the growth spurt and adolescence, can affect their performance in frequently used functional tests such as the 6-Minute Walk Test (6MWT). At the same time, it is emphasized that alternative tests are needed because the evaluation procedures of the 6MWT are not practical enough. The aim of this study is to investigate whether 30 Second Sit to Stand Test (30SST) is an alternative tool for assessing functional capacity in patients with JIA.
H0: 30SST is not an alternative tool for assessing functional capacity in patients with JIA.
H1: 30SST is an alternative tool for assessing functional capacity in patients with JIA.
The study will include 81 adolescent patients with oligoarticular/polyarticular JIA and 116 healthy adolescent between the ages of 12-18. The 6MWT, 30SST and 10 Stair Climb Test (10SCT) will be applied to the cases that meet the inclusion criteria to evaluate their functional capacity. Demographic data and test results of the participants will be recorded and evaluated with statistical analysis methods. We believe that alternative tests that can be used to evaluate functional capacity in patients with JIA will contribute to the literature as a result of this study.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Istanbul, Turkey
- Istanbul University-Cerrahpasa
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Being 12-18 years old for both groups
- Having been diagnosed with JIA at least 6 months ago at the Istanbul Medical Faculty Pediatric Rheumatology Clinic for Usability and Validity Group
- Having a diagnosis of Oligoarticular/Polyarticular JIA for Usability and Validity Group
- Volunteer to participate in the study for both groups
Exclusion Criteria:
- History of trauma or surgery affecting the musculoskeletal system within the last 6 months
- Having an additional chronic disease affecting the musculoskeletal system for both groups
- Having vision or hearing problems for both groups
- Having cognitive impairment at a level where the person cannot understand the commands given for both groups
- Having vision or hearing problems for both groups
- Having had a corticosteroid injection into the knee or ankle within the last week for both groups
- Difference in length in the lower extremities for both groups
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Usability and Validity Group
In order to evaluate the usability of the 30SST, the validity of the test will be examined.
In order to determine its validity in assessing functional capacity, the correlation of 6 MWT and 10SCT will be examined.
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Healthy Control Group
For analysis the difference between JIA and healthy control regarding the 30SST, 6MWT and 10SCT statistical analysis will be performed.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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6 Minute Walk Test (6 MWT)
Time Frame: Time Frame: Baseline
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The 6MWT is a well-tolerated, easy-to-apply and simple test that shows the submaximal level of functional capacity.
This test measures the distance that participants can walk quickly on a hard and flat surface in 6 minutes.
Participants are rested in a chair near the starting position for at least 10 minutes before the test begins.
Participants are instructed on how to perform the test.
At the end of the test, the distance that participants walk in 6 minutes will be recorded in meters.
The 6MWT will be used to evaluate the functional capacity of adolescents.
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Time Frame: Baseline
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30 Second Sit to Stand Test (30SST)
Time Frame: Time Frame: Baseline
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The participant will be asked to sit in a chair with the back straight; Arms will be crossed at the wrists and held towards the chest.
The participant will be encouraged to complete as many sit-ups as possible in 30 seconds.
The participant will be instructed to sit up completely after each sit-up.
The score will be noted as the total number of sit-ups in 30 seconds.
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Time Frame: Baseline
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10 Stairs Climb Test (10SCT)
Time Frame: Time Frame: Baseline
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During the test, participants will be asked to climb 10 steps (14x28x120cm) as fast as possible.
Step climbing times will be measured in seconds with a stopwatch.
The 10SCT will be used to evaluate the functional capacity of adolescents.
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Time Frame: Baseline
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Asena Yekdaneh, MSc. Pt., Fenerbahçe University
- Principal Investigator: Fatma Gül Demirkan, Dr., Istanbul University
- Principal Investigator: Özlem Akgün, Assoc. Prof., Istanbul University
- Principal Investigator: Nuray Aktay Ayaz, Prof., Istanbul University
- Study Director: Nilay Arman, Assoc. Prof., Istanbul University - Cerrahpasa
- Principal Investigator: Asya Albayrak, MSc. Pt., Istanbul University - Cerrahpasa
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NArmann
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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