Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases
LIFT
2 other identifiers
interventional
368
1 country
6
Brief Summary
Fatigue is common and disabling for most patients with inflammatory rheumatic disease. Therapies designed to improve physical activity and 'talking' treatments, which positively help patients change the way they think and behave, are both helpful in reducing the burden of the fatigue. However, few patients have access to these treatments in most health services. This situation results from the absence of standardised programmes and limited availability of relevant therapists. The investigators aim to enhance access to fatigue alleviating physical activity and talking therapies by testing innovative,standardised and cost-effective approaches to treatment delivery. The investigators will also use this opportunity to understand how to select the best treatment for a patient based on their individual profile and to better understand how these treatments actually work. This in turn may lead to more refined and effective therapies in the future.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable rheumatoid-arthritis
Started Sep 2017
Typical duration for not_applicable rheumatoid-arthritis
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 15, 2017
CompletedFirst Posted
Study publicly available on registry
August 14, 2017
CompletedStudy Start
First participant enrolled
September 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 2, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 2, 2020
CompletedSeptember 16, 2021
September 1, 2021
3.2 years
February 15, 2017
September 7, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Fatigue (severity) using Chalder Fatigue Scale (Likert)
Chalder Fatigue Scale (Likert), assessed at 56 weeks after baseline, between-group change CBA+UC vs UC and PEP+UC vs UC with main estimate of treatment effect at 56 weeks after randomisation, Main estimate of treatment effect at 56 weeks
56 weeks
Fatigue (severity) using Chalder Fatigue Scale (Likert)
Chalder Fatigue Scale (Likert), assessed at 10 weeks after baseline, between-group change CBA+UC vs UC and PEP+UC vs UC
10 weeks
Fatigue (severity) using Chalder Fatigue Scale (Likert)
Chalder Fatigue Scale (Likert), assessed at 28 weeks after baseline, between-group change CBA+UC vs UC and PEP+UC vs UC
28 weeks
Fatigue (impact) using Fatigue Severity Scale
Fatigue Severity Scale, co-primary outcome assessed at 56 weeks after baseline, between-group change CBA+UC vs UC and PEP+UC vs UC with main estimate of treatment effect at 56 weeks
56 weeks
Fatigue (impact) using Fatigue Severity Scale
Fatigue Severity Scale, co-primary outcome assessed at 10 weeks after baseline, between-group change CBA+UC vs UC and PEP+UC vs UC
10 weeks
Fatigue (impact) using Fatigue Severity Scale
Fatigue Severity Scale, co-primary outcome assessed at 28 weeks after baseline, between-group change CBA+UC vs UC and PEP+UC vs UC
28 weeks
Secondary Outcomes (7)
Fatigue (physical, living, cognition and emotional aspects) using Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire
0, 10 weeks, 28 weeks, 56 weeks after randomisation
Quality of life & health utility index
0, 10 weeks, 28 weeks, 56 weeks after randomisation
Pain using numerical rating scale
0, 10 weeks, 28 weeks, 56 weeks after randomisation
Anxiety and depression using Hospital anxiety and depression scale
0, 10 weeks, 28 weeks, 56 weeks after randomisation
Impact on work using Work Productivity and Activity Impairment Questionnaire
0, 10 weeks, 28 weeks, 56 weeks after randomisation
- +2 more secondary outcomes
Study Arms (3)
Usual Care alone
ACTIVE COMPARATORParticipants receive written information about fatigue which is designed as self-management guide.
CBA + usual care
ACTIVE COMPARATORIn addition to usual care, participants receive a talking therapy using a cognitive behavioural approach. The talking therapy will be delivered via telephone by a trained rheumatology health care professional who will contact the participant for 8 sessions over a period of 6 months.
PEP + usual care
ACTIVE COMPARATORIn addition to usual care, participants receive a personalised exercise programme. After an initial face-to-face assessment, the remaining programme will be delivered via telephone by a trained rheumatology health care professional who will contact the participant for 7 sessions over a period of 6 months.
Interventions
Information booklet on fatigue which represents usual care in almost all UK rheumatology centres
A talking therapy which explicitly aims to replace unhelpful beliefs and behaviours through the application of patient-centred strategies and behavioural activities
PEP is a graded exposure behaviour therapy which aims to gradually optimise patients levels of physical activity with view to modifying their altered perception of effort and ultimately reduce the severity and impact of fatigue.
Eligibility Criteria
You may qualify if:
- be ≥ 18 years at the time of consent
- have been diagnosed with rheumatoid arthritis (RA), systemic lupus erythematous (SLE), axial spondyloarthritis (AxSpA) or psoriatic arthritis (PSA) by a rheumatologist
- report fatigue to be a persistent problem
- have access to a telephone landline or mobile telephone and/or internet based audio/video calls
- give permission for researchers to access their hospital medical notes
- currently be under the care of a secondary care physician
- have stable disease as evidenced by no change in immunomodulatory therapy within the last three months based on the hospital medical record
You may not qualify if:
- there are significant abnormalities of thyroid function (TSH levels) on the most recent blood test done within the last three months
- there is evidence of severe anaemia (haemoglobin levels) on the most recent blood test done within the last three months
- there is evidence of severe renal dysfunction (eGFR) on the most recent blood test done within the last three months
- they have a medical condition which would make the proposed interventions unsuitable, e.g. significant heart disease
- they are pregnant
- they are unable to understand English sufficiently to take part in the intervention
- they are unable to provide written informed consent
- they are not willing to be randomised
- they are currently participating in an interventional clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aberdeenlead
- Versus Arthritiscollaborator
Study Sites (6)
NHS Grampian
Aberdeen, United Kingdom
NHS Tayside
Dundee, United Kingdom
NHS Lothian
Edinburgh, United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, United Kingdom
Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, NE7 7DN, United Kingdom
Midlands Partnership NHS Foundation Trust
Stoke-on-Trent, ST6 7AG, United Kingdom
Related Publications (3)
Gray SR, Montoye AHK, Vondrasek JD, Neph S, Siebert S, Paul L, Bachmair EM, Basu N. Associations of physical activity levels with fatigue in people with inflammatory rheumatic diseases in the LIFT trial. Rheumatol Adv Pract. 2024 Aug 24;8(3):rkae106. doi: 10.1093/rap/rkae106. eCollection 2024.
PMID: 39257857DERIVEDBachmair EM, Martin K, Aucott L, Dhaun N, Dures E, Emsley R, Gray SR, Kidd E, Kumar V, Lovell K, MacLennan G, McNamee P, Norrie J, Paul L, Packham J, Ralston SH, Siebert S, Wearden A, Macfarlane G, Basu N; LIFT study group. 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. Lancet Rheumatol. 2022 Jun 27;4(8):e534-e545. doi: 10.1016/S2665-9913(22)00156-4. eCollection 2022 Aug.
PMID: 36388001DERIVEDMartin KR, Bachmair EM, Aucott L, Dures E, Emsley R, Gray SR, Hewlett S, Kumar V, Lovell K, Macfarlane GJ, MacLennan G, McNamee P, Norrie J, Paul L, Ralston S, Siebert S, Wearden A, White PD, Basu N. 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). BMJ Open. 2019 Jan 30;9(1):e026793. doi: 10.1136/bmjopen-2018-026793.
PMID: 30705244DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gary Macfarlane, PhD
University of Aberdeen
- PRINCIPAL INVESTIGATOR
Neil Basu, MBChB, PhD
University of Glasgow
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2017
First Posted
August 14, 2017
Study Start
September 5, 2017
Primary Completion
November 2, 2020
Study Completion
November 2, 2020
Last Updated
September 16, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share