Treatment of fatigue with physical activity and behavioural change support in Vasculitis – study protocol for an open-label randomised controlled feasibility study

Lorraine Harper, Matthew Morgan, Dimitrios Chanouzas, Hollie Caulfield, L Coughlan, Caroline Dean, Kate Fletcher, F Cramp, Sheila Greenfield, Catherine Hewitt, Natalie Ives, Sue Jowett, Amanda Daley

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Introduction: Fatigue is a major cause of morbidity, limiting quality of life, in patients with ANCA-associated vasculitis (AAV). The aetiology of fatigue is multi-factorial; 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 to 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 multi-dimensional 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 eight 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: Prospectively registered ISRCTN 11929227 (registered 28.10.2016)
Original languageEnglish
Article numbere023769
JournalBMJ open
Issue number10
Early online date30 Oct 2018
Publication statusPublished - Dec 2018


  • ANCA
  • exercise
  • fatigue
  • self-management
  • vasculitis


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