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CompletedNCT06697028Updated Jun 5, 2025

Assessment of Cardiorespiratory Fitness Using the PACER in Patients With Juvenile Idiopathic Arthritis and Familial Mediterranean Fever

An observational study in Juvenile Idiopathic Arthritis, Familial Mediterranean Fever and Healty Controls, sponsored by Istanbul University - Cerrahpasa. Completed at 1 site in Turkey. Open to participants aged 12 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-05.

Sponsored by Istanbul University - Cerrahpasa · Observational

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Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
216
Ages
12 Years to 18 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 13 studies in Arthritis, Juvenile by Istanbul University - Cerrahpasa — 6 open to participants now, 6 under way, none of them phase 3. Arthritis, Juvenile · Istanbul University - Cerrahpasa.

Started
2024
with 5 others
Observational
5 of 13
4 open now
Registered
8th of 13
by date

Among the 13 studies in Arthritis, Juvenile by Istanbul University - Cerrahpasa, this one is one of 6 that started in 2024, is one of 5 observational ones, and was the 8th registered.

Arthritis, Juvenile

365 studies on the registry are indexed under Arthritis, Juvenile; 101 are open to participants now.

Browse Arthritis, Juvenile studies →

Open to participants now

6 of the 13 studies in Arthritis, Juvenile by Istanbul University - Cerrahpasa are open now, in 1 country. Recruiting first, the newest first:

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By country, each count listing its studies:

All 6 open studies →

Where they have run

Who these studies take

Of the 69 Arthritis, Juvenile studies recruiting now, 13 (19%) set no upper age limit and 50 (72%) stop at 75 or younger; 65 take children under 18; 11 take healthy volunteers.

This study: 12 Years to 18 Years · all sexes · healthy volunteers too.

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02

Study 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 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.

03

Conditions studied

  • Juvenile Idiopathic Arthritis
  • Familial Mediterranean Fever
  • Healty Controls

Keywords

  • Cardiorespiratory fitness
  • Progressive Aerobic Cardiovascular Endurance Run
  • Body composition
  • Maximum oxygen consumption
  • Juvenile Idiopathic Arthritis
  • Familial Mediterranean Fever
04

Who can participate

Ages eligible
12 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
216 participants (actual)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • Juvenile Idiopathic Arthritis

    Patients diagnosed with JIA followed at the Pediatric Rheumatology Clinic, Department of Pediatrics, Istanbul Faculty of Medicine, will be evaluated.

    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.

    Other: Usability and Comparison

  • Healthy control

    The outcomes of individuals with rheumatic diseases will be compared with those of healthy controls.

    Other: Usability and Comparison

Interventions

  • OtherUsability and Comparison

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

  2. Body Mass Index

    Body mass index (BMI), will determined by dividing the body weight in kilograms by the square of the height in meters.

    Time frame: Baseline

  3. VO2 max

    Using the FitnessGram software, the maximum oxygen consumption value (VO2max) will calculated for each individual based on the number of laps completed.

    Time frame: Baseline

07

Study locations

1 site
  • Istanbul University-Cerrahpasa
    Istanbul, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2024 to primary completion in Jan 2025, 0 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 18, 2024
First posted
Nov 20, 2024
StartActual
Dec 25, 2024
Primary completionActual
Jan 11, 2025
CompletionActual
May 11, 2025
Last update
Jun 5, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06697028
Responsible party
Asya Albayrak (MSc, Istanbul Kent University) — Principal investigator
First posted
Nov 20, 2024
Start date
Dec 25, 2024
Primary completion
Jan 11, 2025
Completion
May 11, 2025
Last update
Jun 5, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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