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Responsiveness of an activity tracker as a measurement tool in a knee osteoarthritis clinical trial (ACTIVe-OA study).

Authors
  • Yu, Shirley P1
  • Ferreira, Manuela L2
  • Duong, Vicky2
  • Caroupapoullé, Jimmy3
  • Arden, Nigel K4
  • Bennell, Kim L5
  • Hunter, David J2
  • 1 Department of Rheumatology, Royal North Shore Hospital and Institute of Bone and Joint Research, Kolling Institute, University of Sydney, Sydney, New South Wales, Australia. Electronic address: [email protected] , (Australia)
  • 2 Department of Rheumatology, Royal North Shore Hospital and Institute of Bone and Joint Research, Kolling Institute, University of Sydney, Sydney, New South Wales, Australia. , (Australia)
  • 3 Faculty of Engineering and Physical Sciences, University of Southampton, Southampton, United Kingdom. , (United Kingdom)
  • 4 Centre for Sport, Exercise and Osteoarthritis Versus Arthritis, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom; MRC Lifecourse Epidemiology Unit, Southampton General Hospital, University of Southampton, Southampton, United Kingdom. , (United Kingdom)
  • 5 Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, Faculty of Medicine Dentistry & Health Sciences, The University of Melbourne, Melbourne, Victoria, Australia. , (Australia)
Type
Published Article
Journal
Annals of physical and rehabilitation medicine
Publication Date
Dec 05, 2021
Pages
101619–101619
Identifiers
DOI: 10.1016/j.rehab.2021.101619
PMID: 34879312
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

In osteoarthritis (OA) clinical trials, reliable and responsive outcome measures to document physical and functional improvements are limited. This study aimed to assess whether the use of an activity tracker in an OA clinical trial is a responsive measurement tool. Secondary objectives assessed feasibility and validity. We recruited 65 participants in a prospective cohort study nested in a placebo-controlled clinical trial of platelet-rich plasma injection in knee OA. Participants wore an activity tracker (Fitbit Flex 2), and a smartphone was preloaded with a mobile application (OApp) designed to monitor load rates as a surrogate of knee loading. Participants used the systems for 7 days at baseline and for 7 days before the 2-month follow-up assessment. Effect size (ES) and standardised response mean (SRM) were calculated for change in step count and knee loading rate and regularly used knee OA outcome measures. Correlation coefficients (r) were calculated to examine the strength of the association between outcome measures. Step count showed a trivial ES and SRM and mean knee loading rate measurements a moderate ES and SRM. We found a weak but significant correlation between change in mean steps per day and global improvement overall (r = 0.28) and Western Western Ontario and McMaster Universities Osteoarthritis Index function (r = -0.28). Compliance was high with the activity trackers. Despite good feasibility, this study did not show significant responsiveness or validity of the activity trackers as compared with currently recommended outcome measures in OA clinical trials. The main challenge is the lack of a gold standard outcome measure to validate against, and because of the complex interplay between pain and measured function, a lack of correlation does not necessarily represent a failed validation in this context. Australian New Zealand Clinical Trials Registry: ACTRN12617000853347. This trial is a substudy of the "Platelet-rich plasma as a symptom-and disease-modifying treatment for knee osteoarthritis - the RESTORE trial". Copyright © 2021. Published by Elsevier Masson SAS.

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