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

Research output: Contribution to journalArticlepeer-review

Authors

  • Dimitrios Chanouzas
  • Hollie Caulfield
  • Linda Coughlan
  • Caroline Dean
  • Kate Fletcher
  • Fiona Cramp
  • Natalie Rowland
  • Sue Jowett
  • Shalela Kodabuckus
  • Sarah Tearne
  • Sukhi Sehmi
  • Charlotte Edwardson
  • Nathan P Dawkins
  • Amanda Daley

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.

Details

Original languageEnglish
JournalRheumatology
Early online date22 Jan 2021
Publication statusE-pub ahead of print - 22 Jan 2021

Keywords

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