Taekwondo for Axial Spondyloarthritis

Official title

Efficacy and Safety of a 12-Week Taekwondo Training Program in Patients With Ankylosing Spondylitis and Axial Spondyloarthritis: A Randomized Controlled Trial

Overview

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

Detailed description

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.

1\) Total Taekwondo Intervention Period: 24 Weeks

1. Initial 12 weeks: Comparison between the Taekwondo training group and the control group in an RCT. 2. Post-RCT 12 weeks: The control group receives the same Taekwondo training, allowing for a pre- and post-intervention comparison.

2\) Assessment Time Points

1. Baseline (Pre-Intervention): Within 2 weeks before the start of the 12-week Taekwondo training. 2. End of RCT (Post-Intervention): Within 1 week after completing the initial 12-week Taekwondo training.

The primary effects of the intervention will be assessed through comparisons between the Taekwondo training group and the control group. 3. End of Control Group Intervention: Within 1 week after completing the 12-week Taekwondo training in the control group.

Pre- and post-intervention comparisons will be conducted for the control group. 3) Group Composition

1. Taekwondo Training Group: Participates in a structured 12-week Taekwondo training program during the RCT period. 2. Control Group: Maintains usual daily activities for the initial 12 weeks, followed by participation in the same 12-week Taekwondo training program.

4\) Blinding Procedure

1. Evaluator Blinding: The assessors conducting the outcome evaluations will remain blinded to the intervention status of participants to ensure unbiased assessments. All evaluations will be performed in a neutral setting. 2. Role of the Treating Physician: The treating physician will be responsible for managing participants' medication and medical history but will not be involved in any part of the patient evaluation process, including the assessment of the intervention's effects.

5\) Randomization Method

1. Participants meeting the inclusion and exclusion criteria will undergo stratified randomization to ensure balanced distribution. 2. Stratification factors may include gender, age (below 40 years vs. 40 years and older), or disease severity (presence vs. absence of syndesmophytes on X-ray imaging). Final stratification factors will be determined based on the characteristics of enrolled participants. 3. Randomization will be performed by a designated research team member using Microsoft Excel's random function or other randomization software to allocate participants into the Taekwondo training group and the control group.

Interventions

• Other 12-week Taekwondo training
  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

Primary outcome measures

• Ankylosing Spondylitis Disease Activity Score (ASDAS) [Time frame: Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training)]
• Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [Time frame: Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training)]
• Functional Assessment: Bath Ankylosing Spondylitis Functional Index (BASFI) [Time frame: Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training)]

Secondary outcome measures (10)

• Short Form-12 Health Survey Version 2 (SF-12v2) [Time frame: Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training)]
• Fatigue Severity Scale (FSS) [Time frame: Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training)]
• Ankylosing Spondylitis Quality of Life (ASQoL) [Time frame: Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training)]
• ASAS Health Index (ASAS-HI) [Time frame: Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training)]
• Bath Ankylosing Spondylitis Metrology Index (BASMI) [Time frame: Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training)]
• chest expansion [Time frame: Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training)]
• Numeric Rating Scale (NRS) [Time frame: Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training)]
• Body mass index (BMI) [Time frame: Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training)]
• waist circumference [Time frame: Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training)]
• Korean version of the Center for Epidemiologic Studies Depression Scale - Revised (K-CESD-R) [Time frame: Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training)]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

South Korea · 1 center

• Wonju Severance Christian Hospital — Wŏnju

Publications

• 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 PMID 36261247
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT06823726 · CR324115

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗