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

Lorraine Harper; Catherine Hewitt; Ian  Litchfield; Matthew Morgan; Dimitrios Chanouza; Hollie  Caulfield; University Hospitals Birmingham NHS Trust; Caroline Dean; Kate Fletcher; Fiona Cramp; Sheila  Greenfield; Natalie Ives; Sue Jowett; Shalela Kodabuckus; Sarah Tearne; Sukhwant Semi; Charlotte Edwardson; Nathan 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 Chanouza
, Hollie Caulfield
, University Hospitals Birmingham NHS Trust
, Caroline Dean
, Kate Fletcher
, Fiona Cramp
, Sheila Greenfield
, Natalie Ives
, Sue Jowett
, Shalela Kodabuckus
, Sarah Tearne
, Sukhwant Semi
, Charlotte Edwardson
, Nathan Dawkins
, Amanda Daley

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

13 Citations (Scopus)

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.

Original language	English
Pages (from-to)	4130–4140
Journal	Rheumatology
Volume	60
Issue number	9
Early online date	28 Dec 2020
DOIs	https://doi.org/10.1093/rheumatology/keaa890
Publication status	Published - Sept 2021
Externally published	Yes

Keywords

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

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10.1093/rheumatology/keaa890

Cite this

Harper, L., Hewitt, C., Litchfield, I., Morgan, M., Chanouza, D., Caulfield , H., Trust, U. H. B. NHS., Dean, C., Fletcher, K., Cramp, F., Greenfield , S., Ives, N., Jowett, S., Kodabuckus, S., Tearne, S., Semi, S., Edwardson, C., Dawkins, N., & Daley, A. (2021). Management of fatigue with physical activity and behavioural change support in vasculitis: a feasibility study. Rheumatology, 60(9), 4130–4140. https://doi.org/10.1093/rheumatology/keaa890

@article{25a885f542f3427bbc74efbcd97a4984,

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 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.",

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 Chanouza and Hollie Caulfield and Trust, \{University Hospitals Birmingham NHS\} and Caroline Dean and Kate Fletcher and Fiona Cramp and Sheila Greenfield and Natalie Ives and Sue Jowett and Shalela Kodabuckus and Sarah Tearne and Sukhwant Semi and Charlotte Edwardson and Nathan Dawkins and Amanda Daley",

year = "2021",

month = sep,

doi = "10.1093/rheumatology/keaa890",

language = "English",

volume = "60",

pages = "4130–4140",

journal = "Rheumatology",

number = "9",

}

Harper, L, Hewitt, C, Litchfield, I, Morgan, M, Chanouza, D, Caulfield , H, Trust, UHBNHS, Dean, C, Fletcher, K, Cramp, F, Greenfield , S, Ives, N, Jowett, S, Kodabuckus, S, Tearne, S, Semi, S, Edwardson, C, Dawkins, N & 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 - Chanouza, Dimitrios

AU - Caulfield , Hollie

AU - Trust, University Hospitals Birmingham NHS

AU - Dean, Caroline

AU - Fletcher, Kate

AU - Cramp, Fiona

AU - Greenfield , Sheila

AU - Ives, Natalie

AU - Jowett, Sue

AU - Kodabuckus, Shalela

AU - Tearne, Sarah

AU - Semi, Sukhwant

AU - Edwardson, Charlotte

AU - Dawkins, Nathan

AU - Daley, Amanda

PY - 2021/9

Y1 - 2021/9

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 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.

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 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.

KW - ANCA-associated vasculitis

KW - behavioural change support

KW - fatigue

KW - feasibility study

KW - physical activity

U2 - 10.1093/rheumatology/keaa890

DO - 10.1093/rheumatology/keaa890

M3 - Article

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

Abstract

Keywords

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