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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

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Rheumatology
Protocol
Treatment of fatigue with physical activity and behavioural change support in vasculitis: study protocol for an open-label randomised controlled feasibility study
  1. Lorraine Harper1,
  2. Matthew David Morgan1,
  3. Dimitrios Chanouzas1,
  4. Hollie K Caulfield2,
  5. Linda Coughlan3,
  6. Caroline Dean4,
  7. Kate Fletcher2,
  8. Fiona Cramp5,
  9. Sheila Greenfield6,
  10. Catherine A Hewitt7,
  11. Natalie J Ives7,
  12. Sue Jowett6,
  13. Amanda Daley8
  1. 1Institute of Clinical Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK
  2. 2Institute of Translational Medicine, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK
  3. 3NIHR/Wellcome Trust Clinical Research Facility, UHB NHS Foundation Trust, Birmingham, UK
  4. 4Patient Research Partner
  5. 5Faculty of Health and Applied Sciences, University of the West of England Bristol, Bristol, UK
  6. 6Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK
  7. 7Birmingham Clinical Trials Unit, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK
  8. 8School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK
  1. Correspondence to Professor Lorraine Harper; l.harper{at}bham.ac.uk

Abstract

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.

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

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

https://doi.org/10.1136/bmjopen-2018-023769

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    Footnotes

    • Contributors MDM, DC, HKC, LC, CD, KF, FC, SG, CAH, NJI, SJ, AD, LH: all authors developed and reviewed the protocol; conceived the data analysis plan and the writing of this article; critically reviewed and edited drafts and approved the final version of the manuscript. They also had full access to all of the data (including statistical reports and tables) in the study and can take responsibility for the integrity of the data and the accuracy of the data analysis. LH, the study guarantor.

    • Funding This work was supported by Arthritis Research UK grant number 21199. The study is sponsored by the University of Birmingham. The University of Birmingham holds public liability (negligent harm) and clinical trial (negligent harm) insurance policies, which apply to this trial. The sponsor has been involved in protocol design as well as the development of the case report form.

    • Competing interests None declared.

    • Patient consent Not required.

    • Ethics approval The protocol was reviewed and obtained a favourable opinion by the Health Research Authority (IRAS project ID 210364) on 29 September 2016 and adopted on to the NIHR portfolio.

    • Provenance and peer review Not commissioned; externally peer reviewed.