Axial Spondyloarthritis (AxSpA)
Conditions
Keywords
Pulmonary Rehabilitation, Exercise Tolerance, Dyspnea, Spirometry, Restrictive Lung Disease
Brief summary
This prospective pilot study aims to evaluate the efficacy of a structured 8-week multimodal pulmonary rehabilitation (PR) program specifically designed for patients with radiographic axial spondyloarthritis (r-axSpA). The study assesses the impact of a composite intervention incorporating aerobic conditioning, resistance training, flexibility protocols, and targeted diaphragmatic breathing on functional exercise capacity, dyspnea severity, and pulmonary function.
Interventions
BEHAVIORALMultimodal Pulmonary Rehabilitation
An 8-week structured exercise program consisting of three sessions per week (two supervised hospital-based sessions and one structured home-based session). The intervention integrates aerobic conditioning using a treadmill and arm ergometer, resistance and mobility training targeting spinal extension, and specific respiratory muscle training including diaphragmatic and pursed-lip breathing maneuvers.
Sponsors
Balikesir University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A prospective, single-arm, open-label pilot study to evaluate the feasibility and efficacy of multimodal pulmonary rehabilitation.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 and 75 years. * Diagnosis of radiographic axial spondyloarthritis (r-axSpA) confirmed according to the Modified New York Criteria. * Clinical stability without acute flares or escalation of systemic therapy in the preceding 3 months. * Ability to perform spirometry and ambulate safely.
Exclusion criteria
* Primary respiratory disorders (e.g., COPD and interstitial lung disease) acting as the primary cause of limitation. * Significant cardiovascular contraindications to exercise. * Pregnancy. * Participation in a structured rehabilitation program within the last 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in 6-Minute Walk Distance (6MWD) | Baseline and Week 8 | Functional exercise capacity is measured by the total distance walked in 6 minutes, recorded in meters. Higher values indicate better functional exercise capacity (better outcome). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Borg Dyspnea Scale | Baseline and Week 8 | The Modified Borg Dyspnea Scale is used to assess exertional breathlessness. The scale ranges from a minimum of 0 (no dyspnea at all) to a maximum of 10 (maximal dyspnea). Higher scores indicate more severe breathlessness (worse outcome). |
| Change in Forced Vital Capacity (FVC) | Baseline and Week 8 | Forced Vital Capacity (FVC) is measured via spirometry and expressed as a percentage of the predicted value. Higher percentages indicate better pulmonary volume and respiratory function (better outcome). |
| Change in BASFI Score | Baseline and Week 8 | The Bath Ankylosing Spondylitis Functional Index (BASFI) assesses the degree of functional limitation in daily activities. The scale ranges from a minimum of 0 to a maximum of 10. Higher scores indicate greater functional impairment and disability (worse outcome). |
| Change in SF-36 Mental Health Score | Baseline and Week 8 | The 36-Item Short Form Health Survey (SF-36) is a health-related quality of life questionnaire. The Mental Health domain is scored from a minimum of 0 to a maximum of 100. Higher scores indicate a more favorable mental health state and better well-being (better outcome). |
Countries
Turkey (Türkiye)
Outcome results
None listed