Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
24 participants
INTERVENTIONAL
2025-03-31
2025-11-30
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Taekwondo training group
Participants will undergo a 12-week Taekwondo training program, consisting of three 60-minute sessions per week.
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
Control group
Participants will maintain their usual daily activities for 12 weeks without any structured exercise intervention.
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
2. Age: Between 19 and 59 years old.
3. 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
1. History of orthopedic surgery or fractures within the past 12 months.
2. History of cardiovascular diseases, including ischemic heart disease, cardiomyopathy, heart failure, or stroke.
3. 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).
4. Presence of other musculoskeletal abnormalities or conditions that may limit exercise performance.
5. Diagnosis of cancer within the past 5 years
6. Pregnancy
7. Regular exercise participation within the past 6 months (defined as exercising for at least 60 minutes per session, three or more times per week).
8. Major changes in medication for axial spondyloarthritis during the study period, including:
1. Initiation or discontinuation of biologic agents or targeted therapies.
2. Significant changes in the continued use of NSAIDs or sulfasalazine.
3. Significant changes in the continued use of systemic glucocorticoids.
19 Years
59 Years
ALL
No
Sponsors
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Wonju Severance Christian Hospital
OTHER
Responsible Party
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Nam, Seoung Wan
Assistant Professor, Division of Rheumatology, Department of Internal Medicine
Principal Investigators
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Seoung Wan Nam, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Wonju Severance Christian Hospital
Locations
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Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CR324115
Identifier Type: -
Identifier Source: org_study_id
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