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

Harper, Lorraine; Morgan, Matthew David; Chanouzas, Dimitrios; Caulfield, Hollie K.; Coughlan, Linda; Dean, Caroline; Fletcher, Kate; Cramp, Fiona; Greenfield, Sheila; Hewitt, Catherine A.; Ives, Natalie J.; Jowett, Sue; Daley, Amanda


Lorraine Harper

Matthew David Morgan

Dimitrios Chanouzas

Hollie K. Caulfield

Linda Coughlan

Caroline Dean

Kate Fletcher

Fiona Cramp
Professor in Long Term Conditions

Sheila Greenfield

Catherine A. Hewitt

Natalie J. Ives

Sue Jowett

Amanda Daley


© 2018 Author(s) (or their employer(s)). 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.


Harper, L., Morgan, M. D., Chanouzas, D., Caulfield, H. K., Coughlan, L., Dean, C., …Daley, A. (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.

Journal Article Type Article
Acceptance Date Sep 21, 2018
Publication Date Jan 1, 2018
Journal BMJ Open
Electronic ISSN 2044-6055
Publisher BMJ Publishing Group
Peer Reviewed Peer Reviewed
Volume 8
Issue 10
Pages e023769
Keywords physical activity, vasculitis, protocol
Public URL
Publisher URL


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