Effects of a Digital Functional Exercise Program on the Disease Activities and Physical Capabilities of Patients With Ankylosing Spondylitis: Protocol for a Randomized Controlled Trial
Abstract
Background Ankylosing spondylitis (AS), a chronic inflammatory disease, causes spinal stiffness, functional impairment, and reduced quality of life. While exercise is critical for managing AS, traditional home-based programs lack real-time supervision to ensure movement quality and adherence. Emerging digital tools like inertial sensors may address this gap, but their clinical impact remains unproven. Objective This study aims to evaluate the feasibility and efficacy of a Digital Functional Exercise Program (DFEP) using wearable sensors and real-time feedback for patients with AS. Methods This single-blind randomized controlled trial (ChiCTR2300068327) enrolled 80 adults with AS from the Chinese People’s Liberation Army (PLA) General Hospital. Participants were randomized 1:1 to: DFEP Group: 24-week sensor-guided exercises via the Healbone Mini Program (Jiakangzhongzhi, Co), with real-time feedback and remote physiotherapist oversight. Control Group: standard home-based exercises with written instructions. The primary outcome is the change in Ankylosing Spondylitis Disease Activity Score with C-reactive protein (ASDAS-CRP) at 24 weeks. Secondary outcomes include Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Metrology Index (BASMI), Assessment of Spondyloarthritis International Society Health Index (ASAS HI), 36-Item Short Form Survey (SF-36), pain visual analog scale,…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 80 participants or records.
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