Juvenile Idiopahtic ArthritisNCT06609837
30-Second Sit-to-Stand Test for Assessing Functional Capacity in Juvenile Idiopathic Arthritis
An observational study of Juvenile Idiopahtic Arthritis, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Juvenile Idiopahtic Arthritis
- How many people
- 192 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2024to 30 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Juvenile Idiopahtic Arthritis
- Keywords
- adolescents, Juvenile Idiopahtic Arthritis, functional capacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Time Frame: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start30 Sep 2024
- Primary completion30 Jan 2025
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Idiopahtic ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilay Arman, Istanbul University - Cerrahpasa
- Investigators
- Nilay Arman, Assoc. Prof., Study director, Istanbul University - CerrahpasaAsena Yekdaneh, MSc. Pt., Principal investigator, Fenerbahçe UniversityAsya Albayrak, MSc. Pt., Principal investigator, Istanbul University - CerrahpasaFatma Gül Demirkan, Dr., Principal investigator, Istanbul UniversityÖzlem Akgün, Assoc. Prof., Principal investigator, Istanbul UniversityNuray Aktay Ayaz, Prof., Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06609837
- Sponsor's protocol ID
- NArmann
- Status last verified
- Sep 2024
- First submitted
- 20 Sep 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 30-Second Sit-to-Stand Test as an Alternative Tool for Assessing Functional Capacity in Patients With Juvenile Idiopathic Arthritis
- ClinicalTrials.gov ID
- NCT06609837
- Acronym / sponsor ID
- NArmann
- Conditions
- Juvenile Idiopahtic Arthritis
- Keywords
- adolescents, Juvenile Idiopahtic Arthritis, functional capacity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
6 Minute Walk Test (6 MWT)
Time frame: Time Frame: Baseline
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.
30 Second Sit to Stand Test (30SST)
Time frame: Time Frame: Baseline
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.
10 Stairs Climb Test (10SCT)
Time frame: Time Frame: Baseline
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nilay Arman, Assoc. Prof. study director
Istanbul University - Cerrahpasa
Asena Yekdaneh, MSc. Pt. principal investigator
Fenerbahçe University
Asya Albayrak, MSc. Pt. principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Juvenile Idiopahtic Arthritis, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 Minute Walk Test (6 MWT) (time frame: Time Frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.