SpondylarthritisNCT06546293
Core Stabilization Training in Juvenile Spondyloarthropathy
A study testing core stabilization exercises and daily physical activity program in people with Spondylarthritis and Spondylarthropathies, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Core stabilization exercises developed by McGill have been shown to be one of the physiotherapy techniques aimed at reducing pain, increasing aerobic capacity, enhancing muscle strength, and thereby improving bone health in children with JIA. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Spondylarthritis, Spondylarthropathies, Juvenile Idiopathic Arthritis
- What is being tested?
- core stabilization exercises and daily physical activity program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2024to 31 Jan 2026
- Phase
- Interventional
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- "According to the International League of Associations for Rheumatology criteria, individuals aged 10-18 diagnosed with spondyloarthritis within the JIA subgroup will be included.
- Only cases with stable disease activity and without additional neurological or orthopedic conditions will be considered.
- Participants must also possess the cognitive ability to engage in active rehabilitation.
Who cannot join
- Individuals with a cardiovascular disease that impedes exercise
- those who have participated in a rehabilitation program within the last 6 months
- cases with variable medical treatment will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Core Stabilization Training on Pain, Functional Status, Fatigue, and Quality of Life in Patients With Juvenile Spondyloarthropathy
Core stabilization exercises developed by McGill have been shown to be one of the physiotherapy techniques aimed at reducing pain, increasing aerobic capacity, enhancing muscle strength, and thereby improving bone health in children with JIA. However, there is no study that has investigated core stabilization training for different types of JIA. In our study, we aim to compare the effectiveness of core stabilization training and a daily physical activity program in children with spondyloarthropathy, to help identify the most effective strategy for clinical practice. Additionally, highlighting the specific effects of core stabilization training on the treatment of juvenile spondyloarthropathy (pain, functional status, fatigue, and quality of life) will make a significant contribution to the literature.
Taking into account the gaps in the literature, our study will investigate the effect of core stabilization training on pain, functional status, fatigue, and quality of life in patients with juvenile spondyloarthropathy.
Read the detailed description
Core stabilization exercises are one of the physiotherapy techniques aimed at reducing pain, increasing aerobic capacity, enhancing muscle strength, and thereby improving bone health in children with JIA (1). Spondyloarthropathy typically begins as asymmetric oligoarthritis in children, and enthesitis and axial skeleton involvement may develop over the course of the disease (4). Since juvenile spondyloarthropathies can lead to severe functional impairments and long-term sequelae, the primary goal in treatment should be to suppress inflammation as early as possible and to prevent sequelae (5). Physiotherapy is recommended for children and adolescents with enthesitis or sacroiliitis, or those with functional limitations (6). Yoga exercises focusing on the core region have shown significant effects on lower extremity functional status, pain levels, and quality of life in patients with enthesitis-related conditions (2). Studies have supported that core stabilization exercises, combined with traditional physical therapy aimed at improving bone health status and functional capacity, serve as an effective combination therapy for children with JIA involving multiple joint involvement (3).
Therefore, this study aims to fill the knowledge gap regarding core stabilization training in children with spondyloarthropathy.
- Being tested
- core stabilization exercises, daily physical activity program
- Medical subject headings
- Spondylarthritis, Spondylarthropathies, Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
core stabilization exercisesOther
The program consists of lumbo-pelvic/core strength and stability exercises. The program will be implemented individually under the supervision of a physiotherapist twice a week for 12 weeks.
daily physical activity programOther
The program consists of a daily physical activity program established and monitored for participation through weekly exercise tracking chart. The program will be implemented through weekly physiotherapist's control of the exercise tracking chart for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Core stabilization group | Experimental | lumbo-pelvic/core strength and stability exercises group Receives: Other: core stabilization exercises |
| Control group | Active comparator | the group that will have a daily physical activity program established and monitored for participation through weekly exercise tracking chart Receives: Other: daily physical activity program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
Pain intensity assessment in the lower extremity regions of the sacroiliac joint, hip, knee, and ankle. It is frequently used to quantify the severity or frequency of different symptoms in epidemiologic and clinical research. From the standpoint of the patient, pain seems to be a continuous spectrum rather than discretely varying, as categories like none, mild, moderate, and severe would imply. To represent this concept of an underlying continuum, the VAS was developed.
Measured: immediately after intervention
Secondary outcomes (4)
Six minute walk test
The general functional status of the lower extremities will be evaluated by measuring the six-minute walking distance. The assessment will be conducted along a 15-meter monitored corridor, and the children will be asked to walk as quickly as possible without running. Standard encouragement instructions such as 'keep going' or 'you are doing well' will be used. The children will be allowed to stop and rest during the test, but the countdown will not be paused in these instances. The distance covered over six minutes will be recorded.
Measured: immediately after intervention
Pediatric quality of life
To assess quality of life, the Turkish version of the Pediatric Quality of Life Inventory (PedsQL) 3.0 Arthritis (Rheumatology) Module will be used. The PedsQL 3.0 Arthritis Module includes a total of 22 questions across five different domains: pain and hurt (4 items), daily activities (5 items), treatment (7 items), worry (3 items), and communication (3 items). The questionnaire is available in two forms: a patient form and a parent form. Both the children and one of their parents will complete the PedsQL 3.0 Arthritis Module.
Measured: immediately after intervention
PedsQL-Multidimensional Fatigue Scale
General fatigue, sleep/rest fatigue, cognitive fatigue, and overall fatigue scores will be assessed. Scoring for all child, adolescent, young adult, and parent surveys is conducted on a five-point Likert scale (0 = Never; 1 = Almost Never; 2 = Sometimes; 3 = Often; 4 = Almost Always). A score of 0 indicates high fatigue, while a score of 100 indicates less fatigue on the PedsQL-MFS item scoring.
Measured: immediately after intervention
Timed Up and Down Stairs Test (TUDS)
The individual taking part is standing one foot from the bottom of a 14-step staircase. "Quickly, but safely, go up the stairs, turn around on the top step (landing), and come all the way down until both feet land on the bottom step," is the participant's instruction.
The amount of time, measured in seconds, between the "go" signal and the second foot returning to the bottom landing was the TUDS score. Faster times correlated with higher functional proficiency.
Measured: immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Jul 2024
- Primary completion30 Jun 2025
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for SpondylarthritisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gokce Leblebici, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06546293
- Sponsor's protocol ID
- IUC_SpA_core
- Status last verified
- Jun 2026
- First submitted
- 6 Aug 2024
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
McGill SM, Childs A, Liebenson C. Endurance times for low back stabilization exercises: clinical targets for testing and training from a normal database. Arch Phys Med Rehabil. 1999 Aug;80(8):941-4. doi: 10.1016/s0003-9993(99)90087-4.
PubMed 10453772Yasar E, Kavlak E, Turkucar S, Bayraktar D, Acari C, Unsal E. Yoga versus home exercise program in children with enthesitis related arthritis: A pilot study. Complement Ther Med. 2021 May;58:102696. doi: 10.1016/j.ctim.2021.102696. Epub 2021 Feb 23.
PubMed 33636297Elnaggar RK, Mahmoud WS, Moawd SA, Azab AR. Impact of core stability exercises on bone mineralization and functional capacity in children with polyarticular juvenile idiopathic arthritis: a randomized clinical trial. Clin Rheumatol. 2021 Jan;40(1):245-253. doi: 10.1007/s10067-020-05219-9. Epub 2020 Jun 8.
PubMed 32514677Weiss PF, Roth J. Juvenile-Versus Adult-Onset Spondyloarthritis: Similar, but Different. Rheum Dis Clin North Am. 2020 May;46(2):241-257. doi: 10.1016/j.rdc.2020.01.003.
PubMed 32340699Yildiz M, Haslak F, Adrovic A, Sahin S, Barut K, Kasapcopur O. Juvenile spondyloartropathies. Eur J Rheumatol. 2022 Jan;9(1):42-49. doi: 10.5152/eurjrheum.2021.20235.
PubMed 34101576Ringold S, Angeles-Han ST, Beukelman T, Lovell D, Cuello CA, Becker ML, Colbert RA, Feldman BM, Ferguson PJ, Gewanter H, Guzman J, Horonjeff J, Nigrovic PA, Ombrello MJ, Passo MH, Stoll ML, Rabinovich CE, Schneider R, Halyabar O, Hays K, Shah AA, Sullivan N, Szymanski AM, Turgunbaev M, Turner A, Reston J. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Treatment of Juvenile Idiopathic Arthritis: Therapeutic Approaches for Non-Systemic Polyarthritis, Sacroiliitis, and Enthesitis. Arthritis Rheumatol. 2019 Jun;71(6):846-863. doi: 10.1002/art.40884. Epub 2019 Apr 25.
PubMed 31021537Miro J, Castarlenas E, de la Vega R, Sole E, Tome-Pires C, Jensen MP, Engel JM, Racine M. Validity of three rating scales for measuring pain intensity in youths with physical disabilities. Eur J Pain. 2016 Jan;20(1):130-7. doi: 10.1002/ejp.704. Epub 2015 Mar 31.
PubMed 25833415Lelieveld OT, Takken T, van der Net J, van Weert E. Validity of the 6-minute walking test in juvenile idiopathic arthritis. Arthritis Rheum. 2005 Apr 15;53(2):304-7. doi: 10.1002/art.21086. No abstract available.
PubMed 15818658Zaino CA, Marchese VG, Westcott SL. Timed up and down stairs test: preliminary reliability and validity of a new measure of functional mobility. Pediatr Phys Ther. 2004 Summer;16(2):90-8. doi: 10.1097/01.PEP.0000127564.08922.6A.
PubMed 17057533Tarakci E, Baydogan SN, Kasapcopur O, Dirican A. Cross-cultural adaptation, reliability, and validity of the Turkish version of PedsQL 3.0 Arthritis Module: a quality-of-life measure for patients with juvenile idiopathic arthritis in Turkey. Qual Life Res. 2013 Apr;22(3):531-6. doi: 10.1007/s11136-012-0180-0. Epub 2012 Apr 29.
PubMed 22544413
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Core Stabilization Training on Pain, Functional Status, Fatigue, and Quality of Life in Patients With Juvenile Spondyloarthropathy
- ClinicalTrials.gov ID
- NCT06546293
- Acronym / sponsor ID
- IUC_SpA_core
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 9 Aug 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.
Core stabilization exercises developed by McGill have been shown to be one of the physiotherapy techniques aimed at reducing pain, increasing aerobic capacity, enhancing muscle strength, and thereby improving bone health in children with JIA. However, there is no study that has investigated core stabilization training for different types of JIA. In our study, we aim to compare the effectiveness of core stabilization training and a daily physical activity program in children with spondyloarthropathy, to help identify the most effective strategy for clinical practice. Additionally, highlighting the specific effects of core stabilization training on the treatment of juvenile spondyloarthropathy (pain, functional status, fatigue, and quality of life) will make a significant contribution to the literature.
Taking into account the gaps in the literature, our study will investigate the effect of core stabilization training on pain, functional status, fatigue, and quality of life in patients with juvenile spondyloarthropathy.
Detailed description
Core stabilization exercises are one of the physiotherapy techniques aimed at reducing pain, increasing aerobic capacity, enhancing muscle strength, and thereby improving bone health in children with JIA (1). Spondyloarthropathy typically begins as asymmetric oligoarthritis in children, and enthesitis and axial skeleton involvement may develop over the course of the disease (4). Since juvenile spondyloarthropathies can lead to severe functional impairments and long-term sequelae, the primary goal in treatment should be to suppress inflammation as early as possible and to prevent sequelae (5). Physiotherapy is recommended for children and adolescents with enthesitis or sacroiliitis, or those with functional limitations (6). Yoga exercises focusing on the core region have shown significant effects on lower extremity functional status, pain levels, and quality of life in patients with enthesitis-related conditions (2). Studies have supported that core stabilization exercises, combined with traditional physical therapy aimed at improving bone health status and functional capacity, serve as an effective combination therapy for children with JIA involving multiple joint involvement (3).
Therefore, this study aims to fill the knowledge gap regarding core stabilization training in children with spondyloarthropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Core stabilization group | Experimental | Other: core stabilization exerciseslumbo-pelvic/core strength and stability exercises group |
| Control group | Active comparator | Other: daily physical activity programthe group that will have a daily physical activity program established and monitored for participation through weekly exercise tracking chart |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- "According to the International League of Associations for Rheumatology criteria, individuals aged 10-18 diagnosed with spondyloarthritis within the JIA subgroup will be included.
- Only cases with stable disease activity and without additional neurological or orthopedic conditions will be considered.
- Participants must also possess the cognitive ability to engage in active rehabilitation.
Key exclusion criteria (3 listed)
- Individuals with a cardiovascular disease that impedes exercise
- those who have participated in a rehabilitation program within the last 6 months
- cases with variable medical treatment will be excluded.
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 |
|---|---|---|
| core stabilization exercisesThe program consists of lumbo-pelvic/core strength and stability exercises. The program will be implemented individually under the supervision of a physiotherapist twice a week for 12 weeks. | Other | Core stabilization group |
| daily physical activity programThe program consists of a daily physical activity program established and monitored for participation through weekly exercise tracking chart. The program will be implemented through weekly physiotherapist's control of the exercise tracking chart for 12 weeks. | Other | Control group |
Primary outcome
Visual Analogue Scale
Time frame: immediately after intervention
Pain intensity assessment in the lower extremity regions of the sacroiliac joint, hip, knee, and ankle. It is frequently used to quantify the severity or frequency of different symptoms in epidemiologic and clinical research. From the standpoint of the patient, pain seems to be a continuous spectrum rather than discretely varying, as categories like none, mild, moderate, and severe would imply. To represent this concept of an underlying continuum, the VAS was developed.
4 secondary outcomes
Six minute walk test
Time frame: immediately after intervention
Pediatric quality of life
Time frame: immediately after intervention
PedsQL-Multidimensional Fatigue Scale
Time frame: immediately after intervention
Timed Up and Down Stairs Test (TUDS)
Time frame: immediately after intervention
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 3 Jun 2026.
- Background: PubMed 10453772McGill SM, Childs A, Liebenson C. Endurance times for low back stabilization exercises: clinical targets for testing and training from a normal database. Arch Phys Med Rehabil. 1999 Aug;80(8):941-4. doi: 10.1016/s0003-9993(99)90087-4.
- Background: PubMed 33636297Yasar E, Kavlak E, Turkucar S, Bayraktar D, Acari C, Unsal E. Yoga versus home exercise program in children with enthesitis related arthritis: A pilot study. Complement Ther Med. 2021 May;58:102696. doi: 10.1016/j.ctim.2021.102696. Epub 2021 Feb 23.
- Background: PubMed 32514677Elnaggar RK, Mahmoud WS, Moawd SA, Azab AR. Impact of core stability exercises on bone mineralization and functional capacity in children with polyarticular juvenile idiopathic arthritis: a randomized clinical trial. Clin Rheumatol. 2021 Jan;40(1):245-253. doi: 10.1007/s10067-020-05219-9. Epub 2020 Jun 8.
- Background: PubMed 32340699Weiss PF, Roth J. Juvenile-Versus Adult-Onset Spondyloarthritis: Similar, but Different. Rheum Dis Clin North Am. 2020 May;46(2):241-257. doi: 10.1016/j.rdc.2020.01.003.
- Background: PubMed 34101576Yildiz M, Haslak F, Adrovic A, Sahin S, Barut K, Kasapcopur O. Juvenile spondyloartropathies. Eur J Rheumatol. 2022 Jan;9(1):42-49. doi: 10.5152/eurjrheum.2021.20235.
- Background: PubMed 31021537Ringold S, Angeles-Han ST, Beukelman T, Lovell D, Cuello CA, Becker ML, Colbert RA, Feldman BM, Ferguson PJ, Gewanter H, Guzman J, Horonjeff J, Nigrovic PA, Ombrello MJ, Passo MH, Stoll ML, Rabinovich CE, Schneider R, Halyabar O, Hays K, Shah AA, Sullivan N, Szymanski AM, Turgunbaev M, Turner A, Reston J. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Treatment of Juvenile Idiopathic Arthritis: Therapeutic Approaches for Non-Systemic Polyarthritis, Sacroiliitis, and Enthesitis. Arthritis Rheumatol. 2019 Jun;71(6):846-863. doi: 10.1002/art.40884. Epub 2019 Apr 25.
- Background: PubMed 25833415Miro J, Castarlenas E, de la Vega R, Sole E, Tome-Pires C, Jensen MP, Engel JM, Racine M. Validity of three rating scales for measuring pain intensity in youths with physical disabilities. Eur J Pain. 2016 Jan;20(1):130-7. doi: 10.1002/ejp.704. Epub 2015 Mar 31.
- Background: PubMed 15818658Lelieveld OT, Takken T, van der Net J, van Weert E. Validity of the 6-minute walking test in juvenile idiopathic arthritis. Arthritis Rheum. 2005 Apr 15;53(2):304-7. doi: 10.1002/art.21086. No abstract available.
- Background: PubMed 17057533Zaino CA, Marchese VG, Westcott SL. Timed up and down stairs test: preliminary reliability and validity of a new measure of functional mobility. Pediatr Phys Ther. 2004 Summer;16(2):90-8. doi: 10.1097/01.PEP.0000127564.08922.6A.
- Background: PubMed 22544413Tarakci E, Baydogan SN, Kasapcopur O, Dirican A. Cross-cultural adaptation, reliability, and validity of the Turkish version of PedsQL 3.0 Arthritis Module: a quality-of-life measure for patients with juvenile idiopathic arthritis in Turkey. Qual Life Res. 2013 Apr;22(3):531-6. doi: 10.1007/s11136-012-0180-0. Epub 2012 Apr 29.
- Individual participant dataSharing planned: Undecided
Related trials for Spondylarthritis
Active, not recruitingPhase 1
Safety and Pharmacokinetics of LPX-TI641 in Rheumatoid Arthritis and Psoriatic Arthritis
Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA)
Not yet recruitingObservational study
SLAMF1 Gene Expression in Ankylosing Spondylitis
Ankylosing Spondylitis
Not yet recruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
Recruiting
RENEW Intervention for Axial Spondyloarthritis
Axial Spondyloarthritis
RecruitingObservational study
Natural History and Development of Spondyloarthritis
Arthritis, Spondylitis, Ankylosing
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?
A study testing core stabilization exercises and daily physical activity program in people with Spondylarthritis and Spondylarthropathies, 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 3 inclusion and 3 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 3 Jun 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?
Visual Analogue Scale (time frame: immediately after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06546293, which also lists 10 linked publications.
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 3 Jun 2026.