Taekwondo for Axial Spondyloarthritis

NCT06823726 | Recruiting DMC

• 1 other identifier: CR324115
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if Taekwondo training works to help adults with ankylosing spondylitis and axial spondyloarthritis. It will also learn about the safety of Taekwondo training for these adults. The main questions are as follows:

• Will Taekwondo training affect disease activity, functional improvement, and quality of life?
• Will there be a difference between adults who participate in Taekwondo training and adults who continue with their usual treatment?
• Is Taekwondo training safe for adults with ankylosing spondylitis and axial spondyloarthritis, and will it be an appropriate exercise for these adults?
• Is there a possibility to develop a structured Taekwondo-based exercise program for adults with musculoskeletal disorders? Participants will:
• Be a part of the Taekwondo training group or the control group for 12 weeks (where the control group will later participate in the same 12 week Taekwondo for comparison)
• Be assessed within 2 weeks before the start of the training
• Be assessed within 1 week after completing the training

Conditions

Ankylosing Spondylitis; Axial Spondyloarthritis

Keywords

Taekwondo; Ankylosing Spondylitis; Axial Spondyloarthritis

Outcome Measures

Primary Outcomes (3)

• Ankylosing Spondylitis Disease Activity Score (ASDAS)

  The Ankylosing Spondylitis Disease Activity Score (ASDAS) is a composite index that quantifies disease activity in axial spondyloarthritis, incorporating C-reactive protein (CRP) or erythrocyte sedimentation rate (ESR) along with patient-reported outcomes. ASDAS is a continuous measure, with higher scores indicating greater disease activity. Disease activity is classified as follows: ASDAS \<1.3 (inactive disease), 1.3-2.1 (low activity), 2.1-3.5 (high activity), and \>3.5 (very high activity).

  Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training)

• Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

  The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a self-reported questionnaire designed to assess disease activity in axial spondyloarthritis. It consists of six questions evaluating fatigue, spinal pain, joint pain/swelling, areas of localized tenderness, and morning stiffness (duration and severity). Scores range from 0 (no disease activity) to 10 (worst disease activity), with higher scores indicating greater disease activity.

  Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training)

• Functional Assessment: Bath Ankylosing Spondylitis Functional Index (BASFI)

  The Bath Ankylosing Spondylitis Functional Index (BASFI) is a self-reported 10-item questionnaire designed to assess functional impairment in patients with axial spondyloarthritis. The questions evaluate activities related to daily living and physical function, including mobility, bending, and the ability to perform tasks. Each item is scored on a 0 to 10 scale, where 0 represents no functional limitation and 10 represents the worst functional limitation. Higher BASFI scores indicate greater functional impairment and worse physical function.

  Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training)

Secondary Outcomes (10)

• Short Form-12 Health Survey Version 2 (SF-12v2)

  Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training)

• Fatigue Severity Scale (FSS)

  Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training)

• Ankylosing Spondylitis Quality of Life (ASQoL)

  Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training)

• ASAS Health Index (ASAS-HI)

  Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training)

• Bath Ankylosing Spondylitis Metrology Index (BASMI)

  Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training)

Other Outcomes (1)

• Safety Assessments

  From enrollment to the end of intervention at 24 weeks

Study Arms (2)

Taekwondo training group

EXPERIMENTAL

Participants will undergo a 12-week Taekwondo training program, consisting of three 60-minute sessions per week.

Other: 12-week Taekwondo training

Control group

NO INTERVENTION

Participants will maintain their usual daily activities for 12 weeks without any structured exercise intervention.

Interventions

12-week Taekwondo training OTHER

12-week structured Taekwondo training program under the supervision of qualified instructors following a standardized protocol. Frequency: 3 sessions per week Session Length: 60 minutes per session

Taekwondo training group

Eligibility Criteria

• Age: 19 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosed with axial spondyloarthritis (axSpA) according to the ASAS classification criteria.
• Age: Between 19 and 59 years old.
• Stable medication or non-medication treatment:
• Patients whose medication regimen has remained stable for at least the past 3 months.
• Patients who have not taken medication for axSpA for at least the past 3 months.

You may not qualify if:

• Participants will be excluded from the study if they meet any of the following conditions:
• History of orthopedic surgery or fractures within the past 12 months.
• History of cardiovascular diseases, including ischemic heart disease, cardiomyopathy, heart failure, or stroke.
• Advanced ankylosis in ankylosing spondylitis, as confirmed by radiographic or CT imaging:
• \- Complete ankylosis of at least two regions of the cervical, lumbar, or thoracic spine (i.e., continuous syndesmophyte formation or complete ossification between vertebral bodies).
• Presence of other musculoskeletal abnormalities or conditions that may limit exercise performance.
• Diagnosis of cancer within the past 5 years
• Pregnancy
• Regular exercise participation within the past 6 months (defined as exercising for at least 60 minutes per session, three or more times per week).
• Major changes in medication for axial spondyloarthritis during the study period, including:
• Initiation or discontinuation of biologic agents or targeted therapies.
• Significant changes in the continued use of NSAIDs or sulfasalazine.
• Significant changes in the continued use of systemic glucocorticoids.

Sponsors & Collaborators

• Wonju Severance Christian Hospital: lead

Study Sites (1)

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, 26426, South Korea

RECRUITING

Related Publications (5)

• Ortolan A, Webers C, Sepriano A, Falzon L, Baraliakos X, Landewe RB, Ramiro S, van der Heijde D, Nikiphorou E. Efficacy and safety of non-pharmacological and non-biological interventions: a systematic literature review informing the 2022 update of the ASAS/EULAR recommendations for the management of axial spondyloarthritis. Ann Rheum Dis. 2023 Jan;82(1):142-152. doi: 10.1136/ard-2022-223297. Epub 2022 Oct 19.

  PMID: 36261247 BACKGROUND

• Sveaas SH, Bilberg A, Berg IJ, Provan SA, Rollefstad S, Semb AG, Hagen KB, Johansen MW, Pedersen E, Dagfinrud H. High intensity exercise for 3 months reduces disease activity in axial spondyloarthritis (axSpA): a multicentre randomised trial of 100 patients. Br J Sports Med. 2020 Mar;54(5):292-297. doi: 10.1136/bjsports-2018-099943. Epub 2019 Feb 11.

  PMID: 30745314 BACKGROUND

• Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P; CONSORT Group. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med. 2008 Feb 19;148(4):295-309. doi: 10.7326/0003-4819-148-4-200802190-00008.

  PMID: 18283207 BACKGROUND

• O'Dwyer T, O'Shea F, Wilson F. Exercise therapy for spondyloarthritis: a systematic review. Rheumatol Int. 2014 Jul;34(7):887-902. doi: 10.1007/s00296-014-2965-7. Epub 2014 Feb 19.

  PMID: 24549404 BACKGROUND

• Wang J, Li X, Yang F, Guo P, Ren C, Duan Z, Zhang Y. Efficacy and safety of mind-body exercise for patients with axial spondyloarthritis: a systematic review and meta-analysis. J Orthop Surg Res. 2024 Sep 28;19(1):586. doi: 10.1186/s13018-024-05072-5.

  PMID: 39342350 BACKGROUND

MeSH Terms

Conditions

Spondylitis, Ankylosing; Axial Spondyloarthritis

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Study Officials

• Seoung Wan Nam, M.D., Ph.D.

  Wonju Severance Christian Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seoung Wan Nam, M.D., Ph.D.

CONTACT

82-33-741-1258; dahsome@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Division of Rheumatology, Department of Internal Medicine

Model Details: This study is designed as a single-blind, parallel-group, exploratory pilot randomized controlled trial to evaluate the efficacy and safety of a 12-week Taekwondo training program in patients with ankylosing spondylitis and axial spondyloarthritis.

Study Record Dates

• First Submitted: February 2, 2025
• First Posted: February 12, 2025
• Study Start: March 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: November 1, 2025
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD and supporting information will be available after the publication of study results in a peer-reviewed journal. Data will be available for at least 5 years after publication.
• Access Criteria: De-identified individual participant data (IPD) related to primary and secondary outcomes, as well as supporting documents (Study Protocol, Statistical Analysis Plan, and ICF), will be available to qualified researchers affiliated with academic or medical institutions. Researchers must submit a formal request, including a study proposal, and access will be granted upon approval by the principal investigator and institution under a data-sharing agreement.

Locations

KR (1)