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

doi:10.1093/rheumatology/keaa890

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

Research output: Contribution to journal › Article › peer-review

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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 language	English
Pages (from-to)	4130-4140
Journal	Rheumatology
Volume	60
Issue number	9
Early online date	22 Jan 2021
DOIs	https://doi.org/10.1093/rheumatology/keaa890
Publication status	E-pub ahead of print - 22 Jan 2021

Keywords

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

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10.1093/rheumatology/keaa890Licence: None: All rights reserved

HarperL2021Management
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, 2021;, keaa890, is available online at: https://doi.org/10.1093/rheumatology/keaa890
Accepted author manuscript, 266 KBLicence: None: All rights reserved

Cite this

Harper, L., Hewitt, C., Litchfield, I., Morgan, M., Chanouzas, D., Caulfield, H., Coughlan, L., Dean, C., Fletcher, K., Cramp, F., Greenfield, S., Rowland, N., Jowett, S., Kodabuckus, S., Tearne, S., Sehmi, S., Edwardson, C., Dawkins, N. P., & Daley, A. (2021). Management of fatigue with physical activity and behavioural change support in vasculitis: a feasibility study. Rheumatology, 60(9), 4130-4140. Advance online publication. https://doi.org/10.1093/rheumatology/keaa890

@article{b5fd088a7e0448cc811280e15867313d,

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

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.",

keywords = "ANCA-associated vasculitis, behavioural change support, fatigue, feasibility study, physical activity",

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

year = "2021",

month = jan,

day = "22",

doi = "10.1093/rheumatology/keaa890",

language = "English",

volume = "60",

pages = "4130--4140",

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number = "9",

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Harper, L , Hewitt, C , Litchfield, I, Morgan, M, Chanouzas, D, Caulfield, H, Coughlan, L, Dean, C, Fletcher, K, Cramp, F, Greenfield, S , Rowland, N , Jowett, S, Kodabuckus, S, Tearne, S, Sehmi, S, Edwardson, C, Dawkins, NP & Daley, A 2021, 'Management of fatigue with physical activity and behavioural change support in vasculitis: a feasibility study', Rheumatology, vol. 60, no. 9, pp. 4130-4140. https://doi.org/10.1093/rheumatology/keaa890

TY - JOUR

T1 - Management of fatigue with physical activity and behavioural change support in vasculitis

T2 - a feasibility study

AU - Harper, Lorraine

AU - Hewitt, Catherine

AU - Litchfield, Ian

AU - Morgan, Matthew

AU - Chanouzas, Dimitrios

AU - Caulfield, Hollie

AU - Coughlan, Linda

AU - Dean, Caroline

AU - Fletcher, Kate

AU - Cramp, Fiona

AU - Greenfield, Sheila

AU - Rowland, Natalie

AU - Jowett, Sue

AU - Kodabuckus, Shalela

AU - Tearne, Sarah

AU - Sehmi, Sukhi

AU - Edwardson, Charlotte

AU - Dawkins, Nathan P

AU - Daley, Amanda

PY - 2021/1/22

Y1 - 2021/1/22

N2 - 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.

AB - 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.

KW - ANCA-associated vasculitis

KW - behavioural change support

KW - fatigue

KW - feasibility study

KW - physical activity

UR - https://www.scopus.com/pages/publications/85116317425

U2 - 10.1093/rheumatology/keaa890

DO - 10.1093/rheumatology/keaa890

M3 - Article

SN - 1462-0324

VL - 60

SP - 4130

EP - 4140

JO - Rheumatology

JF - Rheumatology

IS - 9

ER -

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

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Keywords

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