PMID- 30377212 OWN - NLM STAT- MEDLINE DCOM- 20191021 LR - 20220129 IS - 2044-6055 (Electronic) IS - 2044-6055 (Linking) VI - 8 IP - 10 DP - 2018 Oct 30 TI - Treatment of fatigue with physical activity and behavioural change support in vasculitis: study protocol for an open-label randomised controlled feasibility study. PG - e023769 LID - 10.1136/bmjopen-2018-023769 [doi] LID - e023769 AB - 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. CI - (c) 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. FAU - Harper, Lorraine AU - Harper L AUID- ORCID: 0000-0003-1343-9234 AD - Institute of Clinical Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK. FAU - Morgan, Matthew David AU - Morgan MD AD - Institute of Clinical Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK. FAU - Chanouzas, Dimitrios AU - Chanouzas D AD - Institute of Clinical Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK. FAU - Caulfield, Hollie K AU - Caulfield HK AD - Institute of Translational Medicine, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK. FAU - Coughlan, Linda AU - Coughlan L AD - NIHR/Wellcome Trust Clinical Research Facility, UHB NHS Foundation Trust, Birmingham, UK. FAU - Dean, Caroline AU - Dean C AD - Patient Research Partner. FAU - Fletcher, Kate AU - Fletcher K AD - Institute of Translational Medicine, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK. FAU - Cramp, Fiona AU - Cramp F AD - Faculty of Health and Applied Sciences, University of the West of England Bristol, Bristol, UK. FAU - Greenfield, Sheila AU - Greenfield S AD - Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK. FAU - Hewitt, Catherine A AU - Hewitt CA AD - Birmingham Clinical Trials Unit, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK. FAU - Ives, Natalie J AU - Ives NJ AD - Birmingham Clinical Trials Unit, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK. FAU - Jowett, Sue AU - Jowett S AD - Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK. FAU - Daley, Amanda AU - Daley A AD - School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK. LA - eng SI - ISRCTN/ISRCTN11929227 GR - Wellcome Trust/United Kingdom GR - 21199/VAC_/Versus Arthritis/United Kingdom GR - 21199/ARC_/Arthritis Research UK/United Kingdom PT - Clinical Trial Protocol PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20181030 PL - England TA - BMJ Open JT - BMJ open JID - 101552874 SB - IM MH - Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis/*complications MH - *Cognitive Behavioral Therapy MH - *Exercise MH - Fatigue/etiology/*prevention & control MH - Health Behavior MH - Humans MH - Randomized Controlled Trials as Topic MH - Self Efficacy MH - Wearable Electronic Devices PMC - PMC6224747 OTO - NOTNLM OT - ANCA OT - exercise OT - fatigue OT - self-management OT - vasculitis COIS- Competing interests: None declared. EDAT- 2018/11/01 06:00 MHDA- 2019/10/23 06:00 PMCR- 2018/10/30 CRDT- 2018/11/01 06:00 PHST- 2018/11/01 06:00 [entrez] PHST- 2018/11/01 06:00 [pubmed] PHST- 2019/10/23 06:00 [medline] PHST- 2018/10/30 00:00 [pmc-release] AID - bmjopen-2018-023769 [pii] AID - 10.1136/bmjopen-2018-023769 [doi] PST - epublish SO - BMJ Open. 2018 Oct 30;8(10):e023769. doi: 10.1136/bmjopen-2018-023769.