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

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posted on 24.01.2022, 08:55 authored by Lorraine Harper, Catherine A. Hewitt, Ian Litchfield, Matthew D. Morgan, Dimitrios Chanouzas, Hollie K. Caulfield, Linda Coughlan, Caroline Dean, Kate Fletcher, Fiona Cramp, Sheila Greenfield, Natalie J. Ives, Sue Jowett, Shalela Kodabuckus, Sarah Tearne, Sukhwant Sehmi, Charlotte Edwardson, Nathan P. Dawkins, Amanda DaleyAmanda Daley
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.

Funding

Arthritis Research UK grant number 21199

University of Birmingham

NIHR Research Professorship award

History

School

  • Sport, Exercise and Health Sciences

Published in

Rheumatology

Volume

60

Issue

9

Pages

4130 - 4140

Publisher

Oxford University Press

Version

AM (Accepted Manuscript)

Rights holder

© The Authors

Publisher statement

This is a pre-copyedited, author-produced version of an article accepted for publication in Rheumatology following peer review. The version of record Lorraine Harper, Catherine A Hewitt, Ian Litchfield, Matthew D Morgan, Dimitrios Chanouzas, Hollie K Caulfield, Linda Coughlan, Caroline Dean, Kate Fletcher, Fiona Cramp, Sheila Greenfield, Natalie J Ives, Sue Jowett, Shalela Kodabuckus, Sarah Tearne, Sukhwant Sehmi, Charlotte Edwardson, Nathan P Dawkins, Amanda J Daley, Management of fatigue with physical activity and behavioural change support in vasculitis: a feasibility study, Rheumatology, Volume 60, Issue 9, September 2021, Pages 4130–4140, is available online at: https://doi.org/10.1093/rheumatology/keaa890.

Acceptance date

11/11/2020

Publication date

2020-12-28

Copyright date

2020

ISSN

1462-0324

eISSN

1462-0332

Language

en

Depositor

Prof Amanda Daley. Deposit date: 28 November 2021