Clinical trial NCT06546293: Core Stabilization Training in Juvenile Spondyloarthropathy
Official title: The Effect of Core Stabilization Training on Pain, Functional Status, Fatigue, and Quality of Life in Patients with Juvenile Spondyloarthropathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spondylarthritis
Spondylarthropathies
Juvenile Idiopathic Arthritis
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* "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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: immediately after intervention
Secondary outcomes:
measure: Six minute walk test
timeFrame: immediately after intervention
measure: Pediatric quality of life
timeFrame: immediately after intervention
measure: PedsQL-Multidimensional Fatigue Scale
timeFrame: immediately after intervention
measure: Timed Up and Down Stairs Test (TUDS)
timeFrame: immediately after intervention
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
Study officials:
References:
citation: 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.
citation: Yasar 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.
citation: Elnaggar 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.
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citation: Ringold 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.
citation: Miro 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.
citation: Lelieveld 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.
citation: Zaino 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.
citation: Tarakci 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.