Clinical trial NCT06823726: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ankylosing Spondylitis
Axial Spondyloarthritis
Keywords: Taekwondo
Ankylosing Spondylitis
Axial Spondyloarthritis
Lead sponsor: Wonju Severance Christian Hospital
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model 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.
Primary purpose: TREATMENT

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

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.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed with axial spondyloarthritis (axSpA) according to the ASAS classification 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:

Participants will be excluded from the study if they meet any of the following conditions:

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.

Primary outcomes:
measure: Ankylosing Spondylitis Disease Activity Score (ASDAS)
timeFrame: Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training)
measure: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training)
measure: Functional Assessment: Bath Ankylosing Spondylitis Functional Index (BASFI)
timeFrame: Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training)
Secondary outcomes:
measure: Short Form-12 Health Survey Version 2 (SF-12v2)
timeFrame: Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training)
measure: Fatigue Severity Scale (FSS)
timeFrame: Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training)
measure: Ankylosing Spondylitis Quality of Life (ASQoL)
timeFrame: Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training)
measure: ASAS Health Index (ASAS-HI)
timeFrame: Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training)
measure: Bath Ankylosing Spondylitis Metrology Index (BASMI)
timeFrame: Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training)
measure: chest expansion
timeFrame: Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training)
measure: Numeric Rating Scale (NRS)
timeFrame: Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training)
measure: Body mass index (BMI)
timeFrame: Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training)
measure: waist circumference
timeFrame: Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training)
measure: Korean version of the Center for Epidemiologic Studies Depression Scale - Revised (K-CESD-R)
timeFrame: Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training)
Other outcomes:
measure: Safety Assessments
timeFrame: From enrollment to the end of intervention at 24 weeks
Locations:
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
state: Gangwon
Study officials:
affiliation: Wonju Severance Christian Hospital
name: Seoung Wan Nam, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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