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Title: Treatment of fatigue with physical activity and behavioural change support in vasculitis: study protocol for an open-label randomised controlled feasibility study
Authors: Harper, Lorraine
Morgan, Matthew David
Chanouzas, Dimitrios
Caulfield, Hollie K.
Coughlan, Linda
Dean, Caroline
Fletcher, Kate
Cramp, Fiona
Greenfield, Sheila
Hewitt, Catherine
Ives, Natalie
Jowett, Sue
Daley, Amanda J.
Issue Date: 2018
Publisher: © The Authors. Published by BMJ Journals
Citation: HARPER, L. ... et al., 2018. Treatment of fatigue with physical activity and behavioural change support in vasculitis: study protocol for an open-label randomised controlled feasibility study. BMJ Open, 8(10): e023769.
Abstract: © Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. INTRODUCTION: Fatigue is a major cause of morbidity, limiting quality of life, in patients with antineutrophil cytoplasmic antibody-associated vasculitis (AAV). The aetiology of fatigue is multifactorial; biological and psychosocial mediators, such as sleep deprivation, pain and anxiety and depression, are important and may be improved by increasing physical activity. Current self-management advice is based on expert opinion and is poorly adhered to. This study aims to investigate the feasibility of increasing physical activity using a programme of direct contact and telephone support, to provide patient education, encourage behaviour self-monitoring and the development of an individual change plan with defined goals and feedback to treat fatigue compared with standard of care to inform the design of a large randomised controlled trial to test the efficacy and cost effectiveness of this programme.METHODS AND ANALYSIS: Patients with AAV and significant levels of fatigue (patient self-report using multidimensional fatigue index score questionnaire ≥14) will be randomised in a 1:1 ratio to the physical activity programme supported by behavioural change techniques or standard of care. The intervention programme will consist of 8 visits of supervised activity sessions and 12 telephone support calls over 12 weeks with the aim of increasing physical activity to the level advised by government guidelines. Assessment visits will be performed at baseline, 12, 24 and 52 weeks. The study will assess the feasibility of recruitment, retention, the acceptability, adherence and safety of the intervention, and collect data on various assessment tools to inform the design of a large definitive trial. A nested qualitative study will explore patient experience of the trial through focus groups or interviews.ETHICS AND DISSEMINATION: All required ethical and regulatory approvals have been obtained. Findings will be disseminated through conference presentations, patient networks and academic publications.TRIAL REGISTRATION NUMBER: ISRCTN11929227.
Description: This is an Open Access Article. It is published by BMJ journals under the Creative Commons Attribution 4.0 Unported Licence (CC BY). Full details of this licence are available at: http://creativecommons.org/licenses/by/4.0/
Sponsor: This work was supported by Arthritis Research UK grant number 21199. The study is sponsored by the University of Birmingham.
Version: Published
DOI: 10.1136/bmjopen-2018-023769
URI: https://dspace.lboro.ac.uk/2134/36674
Publisher Link: https://doi.org/10.1136/bmjopen-2018-023769
ISSN: 2044-6055
Appears in Collections:Published Articles (Sport, Exercise and Health Sciences)

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