NCT06609837

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
197

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 24, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

September 30, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
Last Updated

May 6, 2025

Status Verified

September 1, 2024

Enrollment Period

4 months

First QC Date

September 20, 2024

Last Update Submit

May 2, 2025

Conditions

Keywords

adolescentsJuvenile Idiopahtic Arthritisfunctional capacity

Outcome Measures

Primary Outcomes (3)

  • 6 Minute Walk Test (6 MWT)

    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.

    Time Frame: Baseline

  • 30 Second Sit to Stand Test (30SST)

    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.

    Time Frame: Baseline

  • 10 Stairs Climb Test (10SCT)

    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.

    Time Frame: Baseline

Study Arms (2)

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.

Healthy Control Group

For analysis the difference between JIA and healthy control regarding the 30SST, 6MWT and 10SCT statistical analysis will be performed.

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Individuals with JIA who come to Istanbul University Medical Faculty, Pediatric Rheumatology Clinic and meet the inclusion criteria for Usability and Validity Group Healthy adolescent participants aged 12-18 years

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpaşa

Istanbul, Turkey (Türkiye)

Location

Study Officials

  • Nilay Arman, Assoc. Prof.

    Istanbul University - Cerrahpasa

    STUDY DIRECTOR
  • Asena Yekdaneh, MSc. Pt.

    Fenerbahçe University

    PRINCIPAL INVESTIGATOR
  • Asya Albayrak, MSc. Pt.

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR
  • Fatma Gül Demirkan, Dr.

    Istanbul University

    PRINCIPAL INVESTIGATOR
  • Özlem Akgün, Assoc. Prof.

    Istanbul University

    PRINCIPAL INVESTIGATOR
  • Nuray Aktay Ayaz, Prof.

    Istanbul University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 20, 2024

First Posted

September 24, 2024

Study Start

September 30, 2024

Primary Completion

January 30, 2025

Study Completion

March 30, 2025

Last Updated

May 6, 2025

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations