Treatment of fatigue with physical activity and behavioural change support in vasculitis: study protocol for an open-label randomised controlled feasibility study
journal contributionposted on 25.01.2019 by Lorraine Harper, Matthew David Morgan, Dimitrios Chanouzas, Hollie K. Caulfield, Linda Coughlan, Caroline Dean, Kate Fletcher, Fiona Cramp, Sheila Greenfield, Catherine Hewitt, Natalie Ives, Sue Jowett, Amanda Daley
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© 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.
This work was supported by Arthritis Research UK grant number 21199. The study is sponsored by the University of Birmingham.
- Sport, Exercise and Health Sciences