Management of fatigue with physical activity and behavioural change support in vasculitis: a feasibility study

Lorraine Harper, Catherine Hewitt, Ian Litchfield, Matthew Morgan, Dimitrios Chanouzas, Hollie Caulfield, Linda Coughlan, Caroline Dean, Kate Fletcher, Fiona Cramp, Sheila Greenfield, Natalie Rowland, Sue Jowett, Shalela Kodabuckus, Sarah Tearne, Sukhi Sehmi, Charlotte Edwardson, Nathan P Dawkins, Amanda Daley

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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 randomised 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 randomised 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: 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 randomised, 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.
Original languageEnglish
JournalRheumatology
Early online date22 Jan 2021
DOIs
Publication statusE-pub ahead of print - 22 Jan 2021

Keywords

  • ANCA-associated vasculitis
  • fatigue
  • feasibility study
  • physical activity
  • behavioural change support

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