Remotely delivered cognitive behavioural and personalised exercise interventions for fatigue severity and impact in inflammatory rheumatic diseases (LIFT): a multicentre, randomised, controlled, open-label, parallel-group trial

LIFT study group

doi:10.1016/S2665-9913(22)00156-4

Remotely delivered cognitive behavioural and personalised exercise interventions for fatigue severity and impact in inflammatory rheumatic diseases (LIFT): a multicentre, randomised, controlled, open-label, parallel-group trial

LIFT study group

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

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Abstract

Background: Chronic fatigue is a poorly managed problem in people with inflammatory rheumatic diseases. Cognitive behavioural approaches (CBA) and personalised exercise programmes (PEP) can be effective, but they are not often implemented because their effectivenesses across the different inflammatory rheumatic diseases are unknown and regular face-to-face sessions are often undesirable, especially during a pandemic. We hypothesised that remotely delivered CBA and PEP would effectively alleviate fatigue severity and life impact across inflammatory rheumatic diseases. Methods: LIFT is a multicentre, randomised, controlled, open-label, parallel-group trial to assess usual care alongside telephone-delivered CBA or PEP against usual care alone in UK hospitals. Patients with any stable inflammatory rheumatic disease were eligible if they reported clinically significant, persistent fatigue. Treatment allocation was assigned by a web-based randomisation system. CBA and PEP sessions were delivered over 6 months by trained health professionals in rheumatology. Coprimary outcomes were fatigue severity (Chalder Fatigue Scale) and impact (Fatigue Severity Scale) at 56 weeks. The primary analysis was by full analysis set. This study was registered at ClinicalTrials.gov (NCT03248518). Findings: From Sept 4, 2017, to Sept 30, 2019, we randomly assigned and treated 367 participants to PEP (n=124; one participant withdrew after being randomly assinged), CBA (n=121), or usual care alone (n=122), of whom 274 (75%) were women and 92 (25%) were men with an overall mean age of 57·5 (SD 12·7) years. Analyses for Chalder Fatigue Scale included 101 participants in the PEP group, 107 in the CBA group, and 107 in the usual care group and for Fatigue Severity Scale included 101 in PEP, 106 in CBA, and 107 in usual care groups. PEP and CBA significantly improved fatigue severity (Chalder Fatigue Scale; PEP: adjusted mean difference −3·03 [97·5% CI −5·05 to −1·02], p=0·0007; CBA: −2·36 [–4·28 to −0·44], p=0·0058) and fatigue impact (Fatigue Severity Scale; PEP: −0·64 [–0·95 to −0·33], p<0·0001; CBA: −0·58 [–0·87 to −0·28], p<0·0001); compared with usual care alone at 56 weeks. No trial-related serious adverse events were reported. Interpretation: Telephone-delivered CBA and PEP produced and maintained statistically and clinically significant reductions in the severity and impact of fatigue in a variety of inflammatory rheumatic diseases. These interventions should be considered as a key component of inflammatory rheumatic disease management in routine clinical practice. Funding: Versus Arthritis

Original language	English
Pages (from-to)	e534-e545
Journal	The Lancet Rheumatology
Volume	4
Issue number	8
Early online date	27 Jun 2022
DOIs	https://doi.org/10.1016/S2665-9913(22)00156-4
Publication status	Published - Aug 2022

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@article{799705c027174a81bd89657ab40cbe75,

title = "Remotely delivered cognitive behavioural and personalised exercise interventions for fatigue severity and impact in inflammatory rheumatic diseases (LIFT): a multicentre, randomised, controlled, open-label, parallel-group trial",

abstract = "Background: Chronic fatigue is a poorly managed problem in people with inflammatory rheumatic diseases. Cognitive behavioural approaches (CBA) and personalised exercise programmes (PEP) can be effective, but they are not often implemented because their effectivenesses across the different inflammatory rheumatic diseases are unknown and regular face-to-face sessions are often undesirable, especially during a pandemic. We hypothesised that remotely delivered CBA and PEP would effectively alleviate fatigue severity and life impact across inflammatory rheumatic diseases. Methods: LIFT is a multicentre, randomised, controlled, open-label, parallel-group trial to assess usual care alongside telephone-delivered CBA or PEP against usual care alone in UK hospitals. Patients with any stable inflammatory rheumatic disease were eligible if they reported clinically significant, persistent fatigue. Treatment allocation was assigned by a web-based randomisation system. CBA and PEP sessions were delivered over 6 months by trained health professionals in rheumatology. Coprimary outcomes were fatigue severity (Chalder Fatigue Scale) and impact (Fatigue Severity Scale) at 56 weeks. The primary analysis was by full analysis set. This study was registered at ClinicalTrials.gov (NCT03248518). Findings: From Sept 4, 2017, to Sept 30, 2019, we randomly assigned and treated 367 participants to PEP (n=124; one participant withdrew after being randomly assinged), CBA (n=121), or usual care alone (n=122), of whom 274 (75%) were women and 92 (25%) were men with an overall mean age of 57·5 (SD 12·7) years. Analyses for Chalder Fatigue Scale included 101 participants in the PEP group, 107 in the CBA group, and 107 in the usual care group and for Fatigue Severity Scale included 101 in PEP, 106 in CBA, and 107 in usual care groups. PEP and CBA significantly improved fatigue severity (Chalder Fatigue Scale; PEP: adjusted mean difference −3·03 [97·5% CI −5·05 to −1·02], p=0·0007; CBA: −2·36 [–4·28 to −0·44], p=0·0058) and fatigue impact (Fatigue Severity Scale; PEP: −0·64 [–0·95 to −0·33], p<0·0001; CBA: −0·58 [–0·87 to −0·28], p<0·0001); compared with usual care alone at 56 weeks. No trial-related serious adverse events were reported. Interpretation: Telephone-delivered CBA and PEP produced and maintained statistically and clinically significant reductions in the severity and impact of fatigue in a variety of inflammatory rheumatic diseases. These interventions should be considered as a key component of inflammatory rheumatic disease management in routine clinical practice. Funding: Versus Arthritis",

author = "{LIFT study group} and Bachmair, {Eva Maria} and Kathryn Martin and Lorna Aucott and Neeraj Dhaun and Emma Dures and Richard Emsley and Gray, {Stuart R.} and Elizabeth Kidd and Vinod Kumar and Karina Lovell and Graeme MacLennan and Paul McNamee and John Norrie and Lorna Paul and Jon Packham and Ralston, {Stuart H.} and Stefan Siebert and Alison Wearden and Gary Macfarlane and Neil Basu",

note = "Funding Information: We thank all the participants who generously supported this trial. We acknowledge the contribution of the Trial Steering Committee and Data Monitoring Committee, and Brian Taylor and Mark Forrest (Centre for Healthcare Randomised Trials [CHaRT], University of Aberdeen, Aberdeen, UK) for their technical assistance. Publisher Copyright: {\textcopyright} 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license",

year = "2022",

month = aug,

doi = "10.1016/S2665-9913(22)00156-4",

language = "English",

volume = "4",

pages = "e534--e545",

journal = "The Lancet Rheumatology",

issn = "2665-9913",

publisher = "Elsevier",

number = "8",

}

Remotely delivered cognitive behavioural and personalised exercise interventions for fatigue severity and impact in inflammatory rheumatic diseases (LIFT): a multicentre, randomised, controlled, open-label, parallel-group trial. / LIFT study group.
In: The Lancet Rheumatology, Vol. 4, No. 8, 08.2022, p. e534-e545.

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

TY - JOUR

T1 - Remotely delivered cognitive behavioural and personalised exercise interventions for fatigue severity and impact in inflammatory rheumatic diseases (LIFT)

T2 - a multicentre, randomised, controlled, open-label, parallel-group trial

AU - LIFT study group

AU - Bachmair, Eva Maria

AU - Martin, Kathryn

AU - Aucott, Lorna

AU - Dhaun, Neeraj

AU - Dures, Emma

AU - Emsley, Richard

AU - Gray, Stuart R.

AU - Kidd, Elizabeth

AU - Kumar, Vinod

AU - Lovell, Karina

AU - MacLennan, Graeme

AU - McNamee, Paul

AU - Norrie, John

AU - Paul, Lorna

AU - Packham, Jon

AU - Ralston, Stuart H.

AU - Siebert, Stefan

AU - Wearden, Alison

AU - Macfarlane, Gary

AU - Basu, Neil

N1 - Funding Information: We thank all the participants who generously supported this trial. We acknowledge the contribution of the Trial Steering Committee and Data Monitoring Committee, and Brian Taylor and Mark Forrest (Centre for Healthcare Randomised Trials [CHaRT], University of Aberdeen, Aberdeen, UK) for their technical assistance. Publisher Copyright: © 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license

PY - 2022/8

Y1 - 2022/8

N2 - Background: Chronic fatigue is a poorly managed problem in people with inflammatory rheumatic diseases. Cognitive behavioural approaches (CBA) and personalised exercise programmes (PEP) can be effective, but they are not often implemented because their effectivenesses across the different inflammatory rheumatic diseases are unknown and regular face-to-face sessions are often undesirable, especially during a pandemic. We hypothesised that remotely delivered CBA and PEP would effectively alleviate fatigue severity and life impact across inflammatory rheumatic diseases. Methods: LIFT is a multicentre, randomised, controlled, open-label, parallel-group trial to assess usual care alongside telephone-delivered CBA or PEP against usual care alone in UK hospitals. Patients with any stable inflammatory rheumatic disease were eligible if they reported clinically significant, persistent fatigue. Treatment allocation was assigned by a web-based randomisation system. CBA and PEP sessions were delivered over 6 months by trained health professionals in rheumatology. Coprimary outcomes were fatigue severity (Chalder Fatigue Scale) and impact (Fatigue Severity Scale) at 56 weeks. The primary analysis was by full analysis set. This study was registered at ClinicalTrials.gov (NCT03248518). Findings: From Sept 4, 2017, to Sept 30, 2019, we randomly assigned and treated 367 participants to PEP (n=124; one participant withdrew after being randomly assinged), CBA (n=121), or usual care alone (n=122), of whom 274 (75%) were women and 92 (25%) were men with an overall mean age of 57·5 (SD 12·7) years. Analyses for Chalder Fatigue Scale included 101 participants in the PEP group, 107 in the CBA group, and 107 in the usual care group and for Fatigue Severity Scale included 101 in PEP, 106 in CBA, and 107 in usual care groups. PEP and CBA significantly improved fatigue severity (Chalder Fatigue Scale; PEP: adjusted mean difference −3·03 [97·5% CI −5·05 to −1·02], p=0·0007; CBA: −2·36 [–4·28 to −0·44], p=0·0058) and fatigue impact (Fatigue Severity Scale; PEP: −0·64 [–0·95 to −0·33], p<0·0001; CBA: −0·58 [–0·87 to −0·28], p<0·0001); compared with usual care alone at 56 weeks. No trial-related serious adverse events were reported. Interpretation: Telephone-delivered CBA and PEP produced and maintained statistically and clinically significant reductions in the severity and impact of fatigue in a variety of inflammatory rheumatic diseases. These interventions should be considered as a key component of inflammatory rheumatic disease management in routine clinical practice. Funding: Versus Arthritis

AB - Background: Chronic fatigue is a poorly managed problem in people with inflammatory rheumatic diseases. Cognitive behavioural approaches (CBA) and personalised exercise programmes (PEP) can be effective, but they are not often implemented because their effectivenesses across the different inflammatory rheumatic diseases are unknown and regular face-to-face sessions are often undesirable, especially during a pandemic. We hypothesised that remotely delivered CBA and PEP would effectively alleviate fatigue severity and life impact across inflammatory rheumatic diseases. Methods: LIFT is a multicentre, randomised, controlled, open-label, parallel-group trial to assess usual care alongside telephone-delivered CBA or PEP against usual care alone in UK hospitals. Patients with any stable inflammatory rheumatic disease were eligible if they reported clinically significant, persistent fatigue. Treatment allocation was assigned by a web-based randomisation system. CBA and PEP sessions were delivered over 6 months by trained health professionals in rheumatology. Coprimary outcomes were fatigue severity (Chalder Fatigue Scale) and impact (Fatigue Severity Scale) at 56 weeks. The primary analysis was by full analysis set. This study was registered at ClinicalTrials.gov (NCT03248518). Findings: From Sept 4, 2017, to Sept 30, 2019, we randomly assigned and treated 367 participants to PEP (n=124; one participant withdrew after being randomly assinged), CBA (n=121), or usual care alone (n=122), of whom 274 (75%) were women and 92 (25%) were men with an overall mean age of 57·5 (SD 12·7) years. Analyses for Chalder Fatigue Scale included 101 participants in the PEP group, 107 in the CBA group, and 107 in the usual care group and for Fatigue Severity Scale included 101 in PEP, 106 in CBA, and 107 in usual care groups. PEP and CBA significantly improved fatigue severity (Chalder Fatigue Scale; PEP: adjusted mean difference −3·03 [97·5% CI −5·05 to −1·02], p=0·0007; CBA: −2·36 [–4·28 to −0·44], p=0·0058) and fatigue impact (Fatigue Severity Scale; PEP: −0·64 [–0·95 to −0·33], p<0·0001; CBA: −0·58 [–0·87 to −0·28], p<0·0001); compared with usual care alone at 56 weeks. No trial-related serious adverse events were reported. Interpretation: Telephone-delivered CBA and PEP produced and maintained statistically and clinically significant reductions in the severity and impact of fatigue in a variety of inflammatory rheumatic diseases. These interventions should be considered as a key component of inflammatory rheumatic disease management in routine clinical practice. Funding: Versus Arthritis

UR - http://www.scopus.com/inward/record.url?scp=85134740046&partnerID=8YFLogxK

U2 - 10.1016/S2665-9913(22)00156-4

DO - 10.1016/S2665-9913(22)00156-4

M3 - Article

AN - SCOPUS:85134740046

SN - 2665-9913

VL - 4

SP - e534-e545

JO - The Lancet Rheumatology

JF - The Lancet Rheumatology

IS - 8

ER -

Remotely delivered cognitive behavioural and personalised exercise interventions for fatigue severity and impact in inflammatory rheumatic diseases (LIFT): a multicentre, randomised, controlled, open-label, parallel-group trial

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