Management of fatigue with physical activity and behavioural change support in vasculitis: a feasibility study. (28th December 2020)

• Record Type: Journal Article
• Authors: Harper, Lorraine; Hewitt, Catherine A; Litchfield, Ian; Morgan, Matthew D; Chanouzas, Dimitrios; Caulfield, Hollie K; Coughlan, Linda; Dean, Caroline; Fletcher, Kate; Cramp, Fiona; Greenfield, Sheila; Ives, Natalie J; Jowett, Sue; Kodabuckus, Shalela; Tearne, Sarah; Sehmi, Sukhwant; Edwardson, Charlotte; Dawkins, Nathan P; Daley, Amanda J
• Is Part Of: Rheumatology. Volume 60:Number 9(2021)
• Page Start: 4130
• Page End: 4140
• Publication Date: 2020-12-28
• Subjects: ANCA-associated vasculitis -- fatigue -- feasibility study -- physical activity -- behavioural change support; Rheumatism -- Periodicals; Rheumatology -- Periodicals; 616.723005
• DOI: 10.1093/rheumatology/keaa890
• Languages: English
• ISSNs: 1462-0324

Abstract

Abstract: Objective: Patients with ANCA-associated vasculitis (AAV) experience high levels of fatigue, despite disease remission. This study assessed the feasibility and acceptability of a definitive randomized controlled trial of a behavioural-based physical activity intervention to support fatigue self-management in AAV patients. Methods: AAV patients in disease remission with fatigue (Multidimensional Fatigue Inventory-20 general fatigue domain ≥ 14 ) were randomly allocated to intervention or standard care in this single-centre open-label randomized controlled feasibility study. The intervention lasted 12 weeks and comprised eight face-to-face physical activity sessions with a facilitator and 12 weekly telephone calls. Participants were encouraged to monitor their physical activity using a tracker device (Fitbit). Standard care involved sign-posting to fatigue websites. The primary outcome was feasibility of a phase III trial assessed against three stop/go traffic light criteria, (recruitment, intervention adherence and study withdrawal). A qualitative study assessed participant views about the intervention. Results: A total of 248 patients were screened and 134 were eligible to participate (54%). Stop/go criteria were amber for recruitment; 43/134 (32%, 95% CI: 24, 40) eligible participants randomized, amber for adherence; 73% of participants attended all eight physical activity sessions, but only 11/22 (50%, 95% CI: 29, 71%) completed the intervention as per the intended schedule, and green for study withdrawal; 2/43 participants withdrew before 24 weeks (5%, 95% CI: 0, 11). Qualitative results suggested the intervention was acceptable. Conclusion: This study suggests a behavioural-based physical activity intervention targeting fatigue self-management was acceptable to patients with AAV, although recruitment and protocol adherence will need modification prior to a definitive trial. Clinical Trial Registration Number: ISRCTN11929227.