Protocol for a multicentre randomised controlled parallel-group trial to compare the effectiveness of remotely delivered cognitive-behavioural and graded exercise interventions with usual care alone to lessen the impact of fatigue in inflammatory rheumatic diseases (LIFT)

Kathryn R. Martin (Lead / Corresponding author), Eva-Maria Bachmair, Lorna Aucott, Emma Dures, Richard Emsley, Stuart R. Gray, Sarah Hewlett, Vinod Kumar, Karina Lovell, Gary J. Macfarlane, Graeme MacLennan, Paul McNamee, John Norrie, Lorna Paul, Stuart Ralston, Stefan Siebert, Alison Wearden, Peter D. White, Neil Basu

    Research output: Contribution to journalArticlepeer-review

    10 Citations (Scopus)
    167 Downloads (Pure)

    Abstract

    Introduction: Fatigue remains pervasive, disabling and challenging to manage across all inflammatory rheumatic diseases (IRDs). Non-pharmacological interventions, specifically cognitive-behavioural approaches (CBAs) and graded exercise programmes designed to support and increase exercise, are valuable treatments which help patients with IRD to manage their fatigue. Yet, healthcare systems have encountered substantial barriers to the implementation of these therapeutic options. Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases: a Randomised Trial (LIFT) is designed to give insights into the effectiveness of a remotely delivered standardised intervention for a range of patients with IRD. It will also enable the exploration of putative moderating factors which may allow for the future triage of patients and to investigate the precise mediators of treatment effect in IRD-related fatigue.

    Methods and analysis: LIFT is a pragmatic, multicentre, three-arm randomised, controlled trial, which will test whether adapted CBA and personalised exercise programme interventions can individually reduce the impact and severity of fatigue. This will be conducted with up to 375 eligible patients diagnosed with IRD and interventions will be delivered by rheumatology healthcare professionals, using the telephone or internet-based audio/video calls.

    Ethics approval and dissemination: Ethical approval has been granted by Wales REC 7 (17/WA/0065). Results of this study will be disseminated through presentation at scientific conferences and in scientific journal. A lay summary of the results will be sent to participants.

    Trial registration number: NCT03248518; Pre-results.

    Original languageEnglish
    Article numbere026793
    Pages (from-to)1-12
    Number of pages12
    JournalBMJ Open
    Volume9
    Issue number1
    Early online date30 Jan 2019
    DOIs
    Publication statusPublished - 30 Jan 2019

    Keywords

    • cognitive behavioural
    • exercise
    • fatigue
    • inflammatory rheumatic disease
    • lift
    • randomised controlled trial

    ASJC Scopus subject areas

    • General Medicine

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