NCT06546293

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 6, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 9, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

March 7, 2025

Status Verified

August 1, 2024

Enrollment Period

11 months

First QC Date

August 6, 2024

Last Update Submit

March 5, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    immediately after intervention

Secondary Outcomes (4)

  • Six minute walk test

    immediately after intervention

  • Pediatric quality of life

    immediately after intervention

  • PedsQL-Multidimensional Fatigue Scale

    immediately after intervention

  • Timed Up and Down Stairs Test (TUDS)

    immediately after intervention

Study Arms (2)

Core stabilization group

EXPERIMENTAL

lumbo-pelvic/core strength and stability exercises group

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

Other: daily physical activity program

Interventions

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.

Core stabilization group

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.

Control group

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • "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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (10)

  • 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.

    PMID: 10453772BACKGROUND
  • 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.

    PMID: 33636297BACKGROUND
  • 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.

    PMID: 32514677BACKGROUND
  • Weiss 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.

    PMID: 32340699BACKGROUND
  • Yildiz 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.

    PMID: 34101576BACKGROUND
  • 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.

    PMID: 31021537BACKGROUND
  • 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.

    PMID: 25833415BACKGROUND
  • 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.

    PMID: 15818658BACKGROUND
  • 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.

    PMID: 17057533BACKGROUND
  • 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.

    PMID: 22544413BACKGROUND

MeSH Terms

Conditions

SpondylarthritisSpondylarthropathiesArthritis, Juvenile

Condition Hierarchy (Ancestors)

SpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Gökçe Leblebici, Pt, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 6, 2024

First Posted

August 9, 2024

Study Start

July 1, 2024

Primary Completion

June 1, 2025

Study Completion

July 1, 2025

Last Updated

March 7, 2025

Record last verified: 2024-08

Locations