JMIR Publications

ABSTRACT

Background:

Ankylosing spondylitis (AS) is a chronic, systemic, rheumatic disease that that serves as the prototype of spondyloarthritis, and is primarily characterized by inflammation of the spine. The main objectives of treatment are to alleviate symptoms, improve functioning, maintain the ability to work, decrease disease complications, and minimize skeletal damage. However, pharmacological therapy alone is often insufficient in managing AS, especially in patients with existing functional limitations. In recent years, mobile devices have undergone dramatic innovations, enabling anytime, anywhere, and real-time connectivity and interactions. Therefore, the portability and connectivity of digital health can potentially serve as an effective tool for long-term follow-up and healthcare delivery for patients with lifelong monitoring needs. To this end, we have now integrated inertial sensors to monitor the functional exercise in patients with AS. Compared to previous methods, this advancement allows for better oversight of exercise, ensuring that patients adhere to well-established functional exercise programs.

Objective:

The aim of this study is to test the feasibility, and efficacy of a digital functional exercise program in influencing disease activities and enhancing physical capabilities in patients with AS.

Methods:

This is a 24-week randomized controlled trail being conducted at Chinese People’s Liberation Army General Hospital. A total of 80 patients, who are enrolled according to specific inclusion and exclusion criteria, will be randomly assigned to either the intervention group or the control group. The primary outcome is Ankylosing Spondylitis Disease Activity Score (ASDAS). Secondary outcomes include Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Metrology Index (BASMI), Spondyloarthritis International Society Health Index (ASAS HI), the 36-item Short Form Survey (SF-36), the Hamilton Depression Scale (HAMD) and the Hamilton Anxiety Scale (HAMA). Retention rate, adherence rate, barriers to being active, and adverse events are also assessed.

Results:

The recruitment of the first participant began on February 27th, 2023.To date, we have screened 216 outpatients who may be eligible, ultimately enrolling a total of 80 participants. The recruitment process was completed by March 5, 2024, and the final participant is expected to complete the study in September 2024. We plan to analyze the complete responses in November 2024, with the publication of the results anticipated by the end of 2024.

Conclusions:

To our knowledge, this study will be the first randomized controlled trial to evaluate a digital functional exercise program focused on disease activity and physical capabilities in patients with AS. If the intervention proves effective, it will provide a highly cost-effective and accessible home-based monitoring and precision exercise program. Based on the current scientific and technological level, this will fill an important gap in supervision methods for this chronic disease such as AS and others. Clinical Trial: Chinese Clinical Trial Registry: ChiCTR2300068327