Taekwondo for Axial Spondyloarthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-59
SponsorWonju Severance Christian Hospital
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosed with axial spondyloarthritis (axSpA) according to the ASAS classification criteria.
Age: Between 19 and 59 years old.
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.
Disqualifiers
History of orthopedic surgery or fractures within the past 12 months.
History of cardiovascular diseases, including ischemic heart disease, cardiomyopathy, heart failure, or stroke.
Presence of other musculoskeletal abnormalities or conditions that may limit exercise performance.
Diagnosis of cancer within the past 5 years
Trial design
Design model
Parallel
Treatments tested in this trial
12-week Taekwondo training
Other intervention12-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
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Taekwondo training groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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).
Time frame
Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training)2
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.
Time frame
Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training)3
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.
Time frame
Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training)Secondary outcomes
1
Short Form-12 Health Survey Version 2 (SF-12v2)
The Short Form-12 Health Survey Version 2 (SF-12v2) is a self-reported measure of health-related quality of life, assessing both physical and mental health across 12 items. The survey generates two summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS), each of which is standardized based on population norms. Scores typically range from 0 to 100, with higher scores indicating better health-related quality of life.
Time frame
Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training)2
Fatigue Severity Scale (FSS)
The Fatigue Severity Scale (FSS) is a 9-item self-reported questionnaire that measures the impact of fatigue on daily activities. Each item is scored on a 1 to 7 scale, where 1 indicates no fatigue impact and 7 indicates maximum fatigue impact. The final score is calculated as the mean of all 9 items, with higher scores indicating greater fatigue severity.
Time frame
Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training)3
Ankylosing Spondylitis Quality of Life (ASQoL)
The Ankylosing Spondylitis Quality of Life (ASQoL) questionnaire is a self-reported 18-item measure assessing disease-specific quality of life in patients with axial spondyloarthritis. Scores range from 0 to 18, with higher scores indicating worse disease-related quality of life.
Time frame
Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training)4
ASAS Health Index (ASAS-HI)
The Ankylosing Spondylitis Assessment Score Health Index (ASAS-HI) is a self-reported questionnaire that assesses overall health status in patients with axial spondyloarthritis. The scale consists of 17 dichotomous items (yes/no), with total scores ranging from 0 to 17. Higher scores indicate worse health status and greater disease burden.
Time frame
Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training)Other outcomes
1
Safety Assessments
1. Adverse Events (AEs): All unexpected adverse effects related to the intervention will be documented. 2. Serious Adverse Events (SAEs): Any life-threatening events, hospitalizations, or significant health deterioration resulting from the intervention will be recorded. 3. Non-intervention-related AEs and SAEs: All adverse events will be recorded and monitored, even if they are not directly related to the intervention, to ensure the overall safety of participants.
Time frame
From enrollment to the end of intervention at 24 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov