Juvenile Idiopathic ArthritisNCT06697028
Assessment of Cardiorespiratory Fitness Using the PACER in Patients With Juvenile Idiopathic Arthritis and Familial Mediterranean Fever
An observational study of Juvenile Idiopathic Arthritis and Familial Mediterranean Fever, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Juvenile Idiopathic Arthritis (JIA) and Familial Mediterranean Fever (FMF) are the most common autoimmune and autoinflammatory rheumatic diseases in childhood. Symptoms such as reduced muscle strength, joint pain, fatigue, and limited activity, which are common in childhood rheumatic diseases, often lead to impaired… Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Juvenile Idiopathic Arthritis, Familial Mediterranean Fever, Healty Controls
- What is being tested?
- Usability and Comparison
- How many people
- 216 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Dec 2024to 11 May 2025
- How long will I take part?
- 1 Day
- 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: Patients diagnosed with JIA and FMF, and their healthy peers without any chronic diseases or disabilities, all aged between 12 to 18 years old will be evaluated with PACER.
Who may be able to join
- Did not have any chronic disease other than rheumatic disease
- Diagnosed with rheumatic disease at least 6 months ago
- Had stable medical treatment
- Being between the ages of 12 and 18
- Volunteering to participate in the study
Who cannot join
- Have experienced trauma or surgery affecting the musculoskeletal system within the last 6 months
- Have acute pain for any reason, have visual or hearing problems
- Have cognitive impairment
- Not volunteering to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Cardiorespiratory Fitness Using the Progressive Aerobic Cardiovascular Endurance Run in Patients With Juvenile Idiopathic Arthritis and Familial Mediterranean Fever: A Healthy Control Study
Juvenile Idiopathic Arthritis (JIA) and Familial Mediterranean Fever (FMF) are the most common autoimmune and autoinflammatory rheumatic diseases in childhood. Symptoms such as reduced muscle strength, joint pain, fatigue, and limited activity, which are common in childhood rheumatic diseases, often lead to impaired physical function. Cardiorespiratory fitness, which is an important indicator of physical function, plays a critical role in health-related outcomes in children and adolescents with rheumatic disease. Maximum oxygen consumption (VO2 peak) is considered the fundamental criterion for evaluating cardiorespiratory fitness. The need for extensive equipment and trained personnel, accompanied with the inability to assess large numbers of children at one-time makes the objective assessment of cardiorespiratory fitness in a clinic setting unmanageable. Therefore, there is a need to assess their cardiorespiratory fitness utilizing an easily administered test that has minimal measurement errors in patients with JIA and FMF. The Progressive Aerobic Cardiovascular Endurance Run (PACER) has become a routine cardiorespiratory fitness assessment for predicting VO2peak in children. A review of the literature revealed that no studies have evaluated CRF using PACER in childhood rheumatic diseases. The aim of this study was to compare the Fitnessgram VO2 max values of children and adolescents diagnosed with JIA and FMF with those of their healthy peers and to examine the relationship with body composition.
- Being tested
- Usability and Comparison
- Keywords
- Cardiorespiratory fitness, Progressive Aerobic Cardiovascular Endurance Run, Body composition, Maximum oxygen consumption, Juvenile Idiopathic Arthritis, Familial Mediterranean Fever
- Medical subject headings
- Arthritis, Juvenile, Familial Mediterranean Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usability and ComparisonOther
PACER will be used to assess cardiorespiratory fitness in individuals with rheumatic diseases. The results will be compared with those of healthy individuals, and the relationship between body composition and VO2 max will be examined.
| Study group | Role | What they receive |
|---|---|---|
| Juvenile Idiopathic Arthritis | Patients diagnosed with JIA followed at the Pediatric Rheumatology Clinic, Department of Pediatrics, Istanbul Faculty of Medicine, will be evaluated. Receives: Other: Usability and Comparison | |
| Familial Mediterranean Fever | Patients diagnosed with FMF followed at the Pediatric Rheumatology Clinic, Department of Pediatrics, Istanbul Faculty of Medicine, will be evaluated. Receives: Other: Usability and Comparison | |
| Healthy control | The outcomes of individuals with rheumatic diseases will be compared with those of healthy controls. Receives: Other: Usability and Comparison |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progressive Aerobic Cardiovascular Endurance Run (PACER)
The PACER test is an adapted version of the 20-meter shuttle run test and consists of multiple stages, serving as a field test. It allows children and adolescents to set their own pace and warm up, serving as a more enjoyable alternative to other distance running tests recommended for use in children, adolescents, and young adults. Utilized to assess patients' cardiorespiratory fitness, individuals were instructed to run back and forth between two cones within a 20-meter course, to the rhythm of music played through a sound recording device, with the test starting at a slow pace and gradually increasing in speed every minute.
Measured: Baseline
Body Mass Index
Body mass index (BMI), will determined by dividing the body weight in kilograms by the square of the height in meters.
Measured: Baseline
VO2 max
Using the FitnessGram software, the maximum oxygen consumption value (VO2max) will calculated for each individual based on the number of laps completed.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start25 Dec 2024
- Primary completion11 Jan 2025
- Study completion11 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 216 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asya Albayrak, Istanbul Kent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06697028
- Sponsor's protocol ID
- AAlbayrak
- Status last verified
- Dec 2024
- First submitted
- 18 Nov 2024
- Last updated
- 5 Jun 2025
- 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 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cardiorespiratory Fitness Using the Progressive Aerobic Cardiovascular Endurance Run in Patients With Juvenile Idiopathic Arthritis and Familial Mediterranean Fever: A Healthy Control Study
- ClinicalTrials.gov ID
- NCT06697028
- Acronym / sponsor ID
- AAlbayrak
- Keywords
- Cardiorespiratory fitness, Progressive Aerobic Cardiovascular Endurance Run, Body composition, Maximum oxygen consumption, Juvenile Idiopathic Arthritis, Familial Mediterranean Fever
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 25 Dec 2024 (actual)
- Primary completion
- 11 Jan 2025 (actual)
- Study completion
- 11 May 2025 (actual)
- First posted
- 20 Nov 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) and Familial Mediterranean Fever (FMF) are the most common autoimmune and autoinflammatory rheumatic diseases in childhood. Symptoms such as reduced muscle strength, joint pain, fatigue, and limited activity, which are common in childhood rheumatic diseases, often lead to impaired physical function. Cardiorespiratory fitness, which is an important indicator of physical function, plays a critical role in health-related outcomes in children and adolescents with rheumatic disease. Maximum oxygen consumption (VO2 peak) is considered the fundamental criterion for evaluating cardiorespiratory fitness. The need for extensive equipment and trained personnel, accompanied with the inability to assess large numbers of children at one-time makes the objective assessment of cardiorespiratory fitness in a clinic setting unmanageable. Therefore, there is a need to assess their cardiorespiratory fitness utilizing an easily administered test that has minimal measurement errors in patients with JIA and FMF. The Progressive Aerobic Cardiovascular Endurance Run (PACER) has become a routine cardiorespiratory fitness assessment for predicting VO2peak in children. A review of the literature revealed that no studies have evaluated CRF using PACER in childhood rheumatic diseases. The aim of this study was to compare the Fitnessgram VO2 max values of children and adolescents diagnosed with JIA and FMF with those of their healthy peers and to examine the relationship with body composition.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Juvenile Idiopathic Arthritis | – | Other: Usability and ComparisonPatients diagnosed with JIA followed at the Pediatric Rheumatology Clinic, Department of Pediatrics, Istanbul Faculty of Medicine, will be evaluated. |
| Familial Mediterranean Fever | – | Other: Usability and ComparisonPatients diagnosed with FMF followed at the Pediatric Rheumatology Clinic, Department of Pediatrics, Istanbul Faculty of Medicine, will be evaluated. |
| Healthy control | – | Other: Usability and ComparisonThe outcomes of individuals with rheumatic diseases will be compared with those of healthy controls. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients diagnosed with JIA and FMF, and their healthy peers without any chronic diseases or disabilities, all aged between 12 to 18 years old will be evaluated with PACER.
Key inclusion criteria (5 listed)
- Did not have any chronic disease other than rheumatic disease
- Diagnosed with rheumatic disease at least 6 months ago
- Had stable medical treatment
- Being between the ages of 12 and 18
- Volunteering to participate in the study
Key exclusion criteria (4 listed)
- Have experienced trauma or surgery affecting the musculoskeletal system within the last 6 months
- Have acute pain for any reason, have visual or hearing problems
- Have cognitive impairment
- Not volunteering to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usability and ComparisonPACER will be used to assess cardiorespiratory fitness in individuals with rheumatic diseases. The results will be compared with those of healthy individuals, and the relationship between body composition and VO2 max will be examined. | Other | Familial Mediterranean Fever, Healthy control, Juvenile Idiopathic Arthritis |
Primary outcome
Progressive Aerobic Cardiovascular Endurance Run (PACER)
Time frame: Baseline
The PACER test is an adapted version of the 20-meter shuttle run test and consists of multiple stages, serving as a field test. It allows children and adolescents to set their own pace and warm up, serving as a more enjoyable alternative to other distance running tests recommended for use in children, adolescents, and young adults. Utilized to assess patients' cardiorespiratory fitness, individuals were instructed to run back and forth between two cones within a 20-meter course, to the rhythm of music played through a sound recording device, with the test starting at a slow pace and gradually increasing in speed every minute.
Body Mass Index
Time frame: Baseline
Body mass index (BMI), will determined by dividing the body weight in kilograms by the square of the height in meters.
VO2 max
Time frame: Baseline
Using the FitnessGram software, the maximum oxygen consumption value (VO2max) will calculated for each individual based on the number of laps completed.
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 5 Jun 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Idiopathic Arthritis and Familial Mediterranean Fever, 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 5 inclusion and 4 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 5 Jun 2025. 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?
Progressive Aerobic Cardiovascular Endurance Run (PACER) (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 5 Jun 2025.