Evidence map›Paper›PMID 41013808›Full record

ArticleTrials2025

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

Lei Huang, Yinghua Pan, Xiaoyun Tang, Hexiao Ding, Qiaorui Wang, Qiwen Ma, Huifen Liu, Hengying Fang

Abstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Lei HuangDepartment of Rheumatology and Immunology, the Third Affiliated Hospital of Sun Yat-Sen University, 600 Tianhe Road, Guangzhou, Guangdong, 510000, People's Republic of China.
Yinghua PanDepartment of Rheumatology and Immunology, the Third Affiliated Hospital of Sun Yat-Sen University, 600 Tianhe Road, Guangzhou, Guangdong, 510000, People's Republic of China.
Xiaoyun TangInternal Medicine Unit Lll, Zhaoqing Hospital, the Third Affiliated Hospital of Sun Yat-Sen University, Zhaoqing, Guangdong, China.
Hexiao DingDepartment of Health Technology and Informatics, the Hong Kong Polytechnic University, Hung Hom, Hong Kong SAR, China.
Qiaorui WangDepartment of Joint Surgery and Traumatic Orthopedics, the Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.
Qiwen MaDepartment of Rheumatology and Immunology, the First People's Hospital of Foshan, Foshan, Guangdong, China.
Huifen LiuDepartment of Rheumatology and Immunology, The Seventh Affiliated Hospital of Sun Yat-Sen University, Shenzhen, China.
Hengying FangDepartment of Nursing, The Third Affiliated Hospital of Sun Yat-Sen University, 600 Tianhe Road, Guangzhou, 510600, China. fanghy@mail.sysu.edu.cn.ORCID http://orcid.org/0000-0002-7835-6918

Funding

Natural Science Foundation of Guangdong Province and Hengrui Medicine Co., Ltd. 2021A1515220110Nursing Scientific Research Funds of the Third Affiliated Hospital of Sun Yat-sen University 2023HLMS04
6 · The paper itself

Abstract

backgroundAnkylosing 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.

methodsThis 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 registrationThe 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).

Indexed as

Exercise TherapySpondylitis, AnkylosingAdultChinaFemaleHumansMaleMobile ApplicationsQuality of LifeRandomized Controlled Trials as TopicSelf EfficacySocial SupportTime FactorsTreatment OutcomeAnkylosing spondylitisASE modelBehavioral interventionDecentralized trialExercise adherence

Identifiers

PMID41013808
PMCPMC12465422

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.