Validation of a long-term and effective physical exercise management for ankylosing spondylitis : study protocol for a decentralized randomized controlled trial

Abstract

Background: Ankylosing spondylitis (AS), a chronic inflammatory disease, leads to significant physical and psychosocial burdens due to progressive spinal rigidity and high disability rates. Although exercise is well-established as a key factor in delaying deformity and enhancing function, maintaining long-term adherence poses a significant hurdle. This study aims to validate the effectiveness of an Exercise Management Mode based on the Attitude-Social Influence-Self-Efficacy (ASE) model (EMM-ASE) in enhancing exercise behavior and clinical outcomes among AS patients. Methods: This decentralized randomized controlled trial (D-RCT) will enroll 120 AS patients from the Guangdong Rheumatology and Immunology Specialty Alliance. Participants will be randomized 1:1 into an intervention group (EMM-ASE) or a control group (routine management). The intervention group receives personalized, stage-based exercise strategies via the AS Exercise Mobile Intelligent Management Platform, including real-time feedback, social support, and biweekly network-broadcasted exercise sessions. The control group receives standard exercise guidance and access to patient support groups. Primary outcomes are exercise level (measured by the International Physical Activity Questionnaire, IPAQ). Secondary outcomes include functional capacity (Bath Ankylosing Spondylitis Functional Index, BASFI), disease activity (Bath Ankylosing Spondylitis Disease Activity Index, BASDAI), fatigue severity (Fatigue Severity Scale, FSS), quality of life (Ankylosing Spondylitis Quality of Life, ASQoL), and exercise adherence. Data will be collected at baseline, 1, 3, and 6 months. Statistical analyses include intention-to-treat analysis using mixed linear models, trajectory analysis via latent class models, and sensitivity analyses. Discussion: The intervention group in this D—RCT, which innovatively applies a mobile platform to AS exercise management, is expected to show more significant improvements in primary and secondary outcomes than the control group. Specifically, at follow—up points, it is anticipated that they will have higher IPAQ scores, lower BASFI scores, and better performance in other indicators. This design would prove the superiority of the EMM—ASE strategy, offering a new effective model for AS treatment. Trial registration: The study protocol was registered with Chinese Clinical Trial Registry on 12 May 2025, https://www.chictr.org.cn/showproj.html?proj=272057 (registration number: ChiCTR2500102260).