Trial · NCT07914439
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Right Diaphragmatic End-Inspiratory Thickness | Baseline (Week 0) and Week 12 | Right diaphragmatic end-inspiratory thickness was assessed using B-mode ultrasonography during deep inspiration. Three measurements were averaged. Thickness was recorded in centimeters, and change from baseline to Week 12 was evaluated. |
| Primary | Change in Left Diaphragmatic End-Inspiratory Thickness | Baseline (Week 0) and Week 12 | Left diaphragmatic end-inspiratory thickness was measured using B-mode ultrasonography during deep inspiration. Three measurements were averaged, and the change in thickness, expressed in centimeters, was evaluated from baseline to Week 12. |
| Primary | Change in Ankylosing Spondylitis Disease Activity Score with C-Reactive Protein (ASDAS-CRP) | Baseline (Week 0) and Week 12 | Disease activity was evaluated using ASDAS-CRP, a composite index incorporating patient-reported symptoms and serum C-reactive protein. Higher scores indicate greater disease activity. Change from baseline to Week 12 was assessed. |
| Primary | Change in Six-Minute Walk Test Distance (6MWT) | Baseline (Week 0) and Week 12 | Functional exercise capacity was evaluated using the six-minute walk test. The total distance walked during six minutes was recorded in meters. Change in walking distance from baseline to Week 12 was assessed. |
| Secondary | Change in Bath Ankylosing Spondylitis Functional Index (BASFI) | Baseline (Week 0) and Week 12 | Functional limitations were evaluated using the 10-item Bath Ankylosing Spondylitis Functional Index. Total scores range from 0 to 10, with higher scores indicating greater functional impairment. Change from baseline to Week 12 was assessed. |
| Secondary | Change in Fatigue Severity Scale (FSS) Score | Baseline (Week 0) and Week 12 | Fatigue was evaluated using the nine-item Fatigue Severity Scale. The mean item score ranges from 1 to 7, with higher scores indicating greater fatigue severity. Change from baseline to Week 12 was assessed. |
| Secondary | Change in Pittsburgh Sleep Quality Index (PSQI) Global Score | Baseline (Week 0) and Week 12 | Sleep quality was assessed using the Pittsburgh Sleep Quality Index, with global scores ranging from 0 to 21. Higher scores indicate poorer sleep quality. Change from baseline to Week 12 was assessed. |
| Secondary | Change in Chest Expansion | Baseline (Week 0) and Week 12 | Chest expansion was assessed using a measuring tape at the nipple line while standing. The difference between maximal inspiration and maximal expiration was measured in centimeters at baseline and Week 12. |
| Secondary | Change in Short Form-36 (SF-36) Health Survey Domain Scores | Baseline (Week 0) and Week 12 | Health-related quality of life was assessed using the eight domains of the SF-36 Health Survey. Domain scores range from 0 to 100, with higher scores indicating better health-related quality of life. Changes from baseline to Week 12 were assessed. |
| Secondary | Change in Right Diaphragmatic End-Expiratory Thickness | Baseline (Week 0) and Week 12 | Right diaphragmatic thickness was measured during deep expiration using B-mode ultrasonography. Three measurements were averaged. Thickness was recorded in centimeters at baseline and Week 12. |
| Secondary | Change in Left Diaphragmatic End-Expiratory Thickness | Baseline (Week 0) and Week 12 | Left diaphragmatic thickness was measured during deep expiration using B-mode ultrasonography. Three measurements were averaged. Thickness was recorded in centimeters at baseline and Week 12. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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