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
BackgroundAnkylosing 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 qualit...
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JMIR Publications
2025-07-01
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| Series: | JMIR Research Protocols |
| Online Access: | https://www.researchprotocols.org/2025/1/e67556 |
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| author | Xingkang Liu Xiaojian Ji Lidong Hu Tianyu Jiang Ang Min Lulu Zeng Yiwen Wang Meihui Zhao Jian Zhu Feng Huang Changshui Weng Zheng Zhao |
| author_facet | Xingkang Liu Xiaojian Ji Lidong Hu Tianyu Jiang Ang Min Lulu Zeng Yiwen Wang Meihui Zhao Jian Zhu Feng Huang Changshui Weng Zheng Zhao |
| author_sort | Xingkang Liu |
| collection | DOAJ |
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BackgroundAnkylosing 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.
ObjectiveThis 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.
MethodsThis 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, Five-Times-Sit-to-Stand, 4-meter walk test, Hamilton Anxiety Scale (HAMA), Hamilton Depression Scale (HAMD), and adherence. Analyses will follow an intention-to-treat approach with the Last Observation Carried Forward for missing data; continuous variables will be compared with t tests or ANOVA, and categorical variables with chi-square tests, using a 2-sided =.05.
ResultsWe have screened 216 outpatients who may be eligible subjects, among them 126 outpatients who initially met the inclusion criteria. After evaluating clinicians performed face-to-face assessments, 23 lacked a stable medication regimen, 5 presented with severe cervical vertebral bridges, 3 reported regular structured exercise, 2 could not be reached after prescreening, 10 had significant cardiovascular disease, and 3 declined participation due to time constraints. Ultimately, 80 eligible participants were enrolled, with 36 randomly allocated to the intervention group and 44 to the control group. Recruitment (February 2023-March 2024) and follow-up (concluding September 2024) are complete. Data analysis (November 2024) and result dissemination (April 2025) are pending.
ConclusionsThis trial is the first to test a fully digital, sensor-based exercise program for AS. If effective, DFEP could offer a scalable, cost-effective solution for home rehabilitation in AS and related conditions.
Trial RegistrationChinese Clinical Trial Registry ChiCTR2300068327; https://www.chictr.org.cn/showproj.html?proj=190897
International Registered Report Identifier (IRRID)DERR1-10.2196/67556 |
| format | Article |
| id | doaj-art-904e18a6400d4ec2a19481d02c119ccc |
| institution | DOAJ |
| issn | 1929-0748 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | JMIR Publications |
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| series | JMIR Research Protocols |
| spelling | doaj-art-904e18a6400d4ec2a19481d02c119ccc2025-08-20T03:17:40ZengJMIR PublicationsJMIR Research Protocols1929-07482025-07-0114e6755610.2196/67556Effects of a Digital Functional Exercise Program on the Disease Activities and Physical Capabilities of Patients With Ankylosing Spondylitis: Protocol for a Randomized Controlled TrialXingkang Liuhttps://orcid.org/0000-0002-9235-5778Xiaojian Jihttps://orcid.org/0000-0003-4753-191XLidong Huhttps://orcid.org/0000-0001-5004-187XTianyu Jianghttps://orcid.org/0000-0002-4193-5051Ang Minhttps://orcid.org/0009-0008-7039-1963Lulu Zenghttps://orcid.org/0009-0002-3132-8589Yiwen Wanghttps://orcid.org/0000-0003-2495-6552Meihui Zhaohttps://orcid.org/0009-0000-9737-0531Jian Zhuhttps://orcid.org/0000-0002-6244-9917Feng Huanghttps://orcid.org/0000-0002-2319-873XChangshui Wenghttps://orcid.org/0009-0008-7768-5569Zheng Zhaohttps://orcid.org/0000-0002-7391-4001 BackgroundAnkylosing 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. ObjectiveThis 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. MethodsThis 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, Five-Times-Sit-to-Stand, 4-meter walk test, Hamilton Anxiety Scale (HAMA), Hamilton Depression Scale (HAMD), and adherence. Analyses will follow an intention-to-treat approach with the Last Observation Carried Forward for missing data; continuous variables will be compared with t tests or ANOVA, and categorical variables with chi-square tests, using a 2-sided =.05. ResultsWe have screened 216 outpatients who may be eligible subjects, among them 126 outpatients who initially met the inclusion criteria. After evaluating clinicians performed face-to-face assessments, 23 lacked a stable medication regimen, 5 presented with severe cervical vertebral bridges, 3 reported regular structured exercise, 2 could not be reached after prescreening, 10 had significant cardiovascular disease, and 3 declined participation due to time constraints. Ultimately, 80 eligible participants were enrolled, with 36 randomly allocated to the intervention group and 44 to the control group. Recruitment (February 2023-March 2024) and follow-up (concluding September 2024) are complete. Data analysis (November 2024) and result dissemination (April 2025) are pending. ConclusionsThis trial is the first to test a fully digital, sensor-based exercise program for AS. If effective, DFEP could offer a scalable, cost-effective solution for home rehabilitation in AS and related conditions. Trial RegistrationChinese Clinical Trial Registry ChiCTR2300068327; https://www.chictr.org.cn/showproj.html?proj=190897 International Registered Report Identifier (IRRID)DERR1-10.2196/67556https://www.researchprotocols.org/2025/1/e67556 |
| spellingShingle | Xingkang Liu Xiaojian Ji Lidong Hu Tianyu Jiang Ang Min Lulu Zeng Yiwen Wang Meihui Zhao Jian Zhu Feng Huang Changshui Weng Zheng Zhao 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 JMIR Research Protocols |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://www.researchprotocols.org/2025/1/e67556 |
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