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Gait as predictor of physical function in axial spondyloarthritis: the prospective longitudinal FOLOMI (Function, Locomotion, Measurement, Inflammation) study protocol

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Abstract

Axial spondyloarthritis (axSpA) is a chronic inflammatory rheumatic disease affecting predominantly sacroiliac joints and axial skeleton. axSpA progression being irregular and hardly predictable, identifying functional decline is particularly important in patient with axSpA to allow delivery of timely and targeted interventions. Pain, reduced range of motion or altered posture can have adverse consequences on gait. Although gait has previously been used as a sensitive measure of physical outcomes in elderly and pathological populations, to the best of our knowledge, no study has used gait as a predictor of physical function in patients with axSpA. The objective of our study is hence to determine if gait parameters measured in patients with axSpA could predict the evaluation at 18 months of physical function as assessed by the Bath Ankylosing Spondylitis Functional Index (BASFI). This is a prospective and longitudinal study. Sixty patients with axSpA and 30 healthy age- and sex-matched controls will be included. Patients should be aged 18–65 years at time of their first evaluation, followed at Grenoble Alpes University Hospital for axSpA or ankylosing spondylitis, able to walk 180 m without technical help and with stable treatment for at least 12 months. Clinical characteristics, BASFI, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), clinical and laboratory measurements of gait will be assessed during four visits (at baseline and at months 6, 12, and 18). Similar assessments will be performed once for the healthy control group. A linear mixed model at 6, 12 and 18 months will be constructed to answer to the first objective, with the BASFI as dependent variable and gait parameters as explanatory variables. The data collection started in August 2018 and will be completed with the inclusion and follow-up of all the participants. We believe that the combination of clinical and laboratory measurements of gait in patients with axSpA could strengthen the capacity to monitor disease’s evolution and to predict changes in patients’ physical function. Results of the present study could ultimately allow delivering targeted, timely, personalized interventions and treatment in patients with axSpA.

Trial registration: The study was approved by local ethic committee (CPP Ile De France 1, RCB: 2017-A03468-45, date of agreement: July 17th, last version: V4.0, 2018, March 5th, 2019) and is retrospectively registered in Clinical trials (NCT03761212).

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Abbreviations

10MWT:

10-Meter Walk Test

AS:

Ankylosing spondylitis

BASFI:

Bath Ankylosing Spondylitis Functional Index

BASDAI:

Bath Ankylosing Spondylitis Disease Activity Index

GPAQ:

Global Physical Activity Questionnaire

iTUG:

Instrumented Timed Up and Go

i6MWT:

Instrumented 6-Minute Walk Test

IPAQ:

International Physical Activity Questionnaire

SF-36:

Short Form 36

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Funding

This study is part of the Ph.D. thesis of the first author Julie Soulard (Univ. Grenoble Alpes, AGEIS, France and Grenoble Alps University Hospital, Grenoble, France). This work is supported by the French Ministry of Health and Solidarity with the “Nursing and Paramedical Hospital Research Program” year 2016 (PHRIP-16-0528) and by the French National Research Agency in the framework of the “Investissements d’avenir” program (ANR-10-AIRT-05 and ANR-15-IDEX-02). The sponsors had no involvement in the design of the study, the collection, analysis and interpretation of data, and in writing the manuscript. This work further forms part of a broader translational and interdisciplinary research program, GaitAlps.

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Authors and Affiliations

  1. Univ. Grenoble Alpes, AGEIS, 38000, Grenoble, France

    Julie Soulard, Nicolas Vuillerme & Jacques Vaillant

  2. Neurology Department, Grenoble Alpes University Hospital, Grenoble, France

    Julie Soulard

  3. Institut Universitaire de France, Paris, France

    Nicolas Vuillerme

  4. Rheumatology Department, Grenoble Alpes University Hospital, Grenoble, France

    Philippe Gaudin, Laurent Grange, Athan Baillet & Robert Juvin

  5. Univ. Grenoble Alpes, CNRS, CHU Grenoble Alpes, Grenoble INP, TIMC-IMAG, Grenoble, France

    Philippe Gaudin & Athan Baillet

  6. Clinical Pharmacology Department, Grenoble Alpes University Hospital, Grenoble, France

    Jean-Luc Cracowski

  7. Univ. Grenoble Alpes HP2 Laboratory, Grenoble, France

    Jean-Luc Cracowski

Authors
  1. Julie Soulard
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  2. Nicolas Vuillerme
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  3. Philippe Gaudin
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  4. Laurent Grange
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  7. Robert Juvin
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  8. Jacques Vaillant
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Contributions

All authors have contributed to the design of this project. JS and NV wrote the manuscript and all authors read and approved this manuscript.

Corresponding author

Correspondence to Julie Soulard.

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Conflict of interest

The authors declare that they have no proprietary, financial, professional, or other competing interests regarding this study and the publication of this paper.

Ethics approval and consent to participate

The study was approved by local ethic committee (CPP IDF1, RCB: 2017-A03468-45, date of agreement: July 17th, last version: V4.0, 2018, March 5th, 2019). This study protocol is registered on ClinicalTrials.gov, with the following ID: NCT03761212 and follow the SPIRIT checklist. Written informed consent will be obtained from all participants by the physiotherapist or a medical doctor. Any modification to the initial protocol will be presented to the local ethics committee and has to be accepted before application and will be registered on ClinicalTrials.gov.

Data management

Data of the participants are anonymized with a participant number. A clinical research associate, mandated by the Grenoble Alpes University Hospital, will monitor the study depending on inclusion rhythm and following a pre-prepared plan. Each monitoring will be associated with a written record. Besides, an audit or an inspection by health authorities can be conducted, independently of the sponsor and promotor, at any time to ensure research quality, result validity, and law respect.

Trial status

The data collection started in August 2018 and will be completed with the inclusion and follow-up of all the participants (60 patients with axSpA and 30 healthy controls). We plan the results of this study to be presented at international oriented scientific and clinical conferences and to be published in peer-reviewed scientific journals.

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Soulard, J., Vuillerme, N., Gaudin, P. et al. Gait as predictor of physical function in axial spondyloarthritis: the prospective longitudinal FOLOMI (Function, Locomotion, Measurement, Inflammation) study protocol. Rheumatol Int 39, 1681–1688 (2019). https://doi.org/10.1007/s00296-019-04396-4

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