Rheumatoid ArthritisLIFTNCT03248518
Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases
A study testing Cognitive behavioural approach and Personalised Exercise Programme in people with Rheumatoid Arthritis and Lupus Erythematosus, Systemic, run by University of Aberdeen at 6 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Lupus Erythematosus, Systemic, Axial Spondyloarthritis
- What is being tested?
- Cognitive behavioural approach and Personalised Exercise Programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 368 participants
- Where
- 6 sitesUnited Kingdom
- Study dates
- 5 Sep 2017to 2 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- they are unable to provide written informed consent
- they are not willing to be randomised
- they are currently participating in an interventional clinical trial
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United Kingdom6 sites
NHS Grampian
Aberdeen
NHS Tayside
Dundee
NHS Lothian
Edinburgh
NHS Greater Glasgow and Clyde
Glasgow
Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, NE7 7DN
Midlands Partnership NHS Foundation Trust
Stoke-on-Trent, ST6 7AG
About this study
Official title: Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases: A Randomised Clinical Trial
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.
Read the detailed description
Eligible participants will be identified from patients with inflammatory rheumatic diseases attending major secondary care rheumatology services in the United Kingdom. Potential participants will be identified using local databases/clinic lists and will then be mailed a pre-study invite, which will include questions about fatigue. Potentially eligible participants will be invited to attend a baseline assessment.
Once it has been confirmed at the baseline assessement that they are eligible to take part in the study, the consented participant will be allocated to one of three treatment groups. During the course of the trial, the participant will be invited to visit the study centre three more times for assessments.
At each of the four assessment visits (baseline, and approximately 2, 7 and 13 months after) they will be asked:
- To complete questionnaires which collect information about various outcomes which we think will improve in response to the therapies under evaluation as well as factors which will help us understand how the treatments may work, and factors which may help identify those patients better suited to one therapy over another
- To provide a blood sample for research
- To take part in an aerobic fitness test
- To wear an activity monitor for the next 7 days which will be fitted at each visit
- To answer three short questions about engagement with intervention delivered by telephone from trial office at the time of session 4 and 8 (CBA and PEP intervention only). Similarly, the allocated therapists will be asked to give their view of the participants' engagement with the intervention.
All participants will be asked to keep a diary on any other treatments they are using in addition to the treatments they may receive during the study and how costly these other treatments are. The diary period will last for the first 6 months and then for 2 weeks after the third visit and 2 weeks before the last visit.
After they finished the study, the investigators may approach a subgroup of participants who received either the talking therapy or the personalised exercise programme again and ask for an interview to enable more detailed feedback on if they found the intervention helpful and how it has changed their daily life.
- Conditions
- Rheumatoid Arthritis, Lupus Erythematosus, Systemic, Axial Spondyloarthritis, Psoriatic Arthritis, Sjogren's Syndrome
- Being tested
- Usual Care, Cognitive behavioural approach, Personalised Exercise Programme
- Keywords
- Inflammatory Rheumatic Disease, Fatigue, Exercise, Behavioural Intervention, Rheumatoid Arthritis, Systemic Lupus Erythematosus, Axial Spondyloarthritis
- Medical subject headings
- Arthritis, Rheumatoid, Lupus Erythematosus, Systemic, Axial Spondyloarthritis, Arthritis, Psoriatic, Sjogren's Syndrome, Fatigue, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareBehavioural
Information booklet on fatigue which represents usual care in almost all UK rheumatology centres
Cognitive behavioural approachBehavioural
Also called CBA
A talking therapy which explicitly aims to replace unhelpful beliefs and behaviours through the application of patient-centred strategies and behavioural activities
Personalised Exercise ProgrammeBehavioural
Also called PEP
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care alone | Active comparator | Participants receive written information about fatigue which is designed as self-management guide. Receives: Behavioral: Usual Care |
| CBA + usual care | Active comparator | In 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. Receives: Behavioral: Usual Care; Behavioral: Cognitive behavioural approach |
| PEP + usual care | Active comparator | In 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. Receives: Behavioral: Usual Care; Behavioral: Personalised Exercise Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 28 weeks
Secondary outcomes (7)
Fatigue (physical, living, cognition and emotional aspects) using Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire
Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire
Measured: 0, 10 weeks, 28 weeks, 56 weeks after randomisation
Quality of life & health utility index
SF-12
Measured: 0, 10 weeks, 28 weeks, 56 weeks after randomisation
Pain using numerical rating scale
Pain numerical rating scale
Measured: 0, 10 weeks, 28 weeks, 56 weeks after randomisation
Anxiety and depression using Hospital anxiety and depression scale
Hospital anxiety and depression scale
Measured: 0, 10 weeks, 28 weeks, 56 weeks after randomisation
Impact on work using Work Productivity and Activity Impairment Questionnaire
Work Productivity and Activity Impairment Questionnaire: Specific Health Problem
Measured: 0, 10 weeks, 28 weeks, 56 weeks after randomisation
Impact on activities using Valued Life Activities Scale
Valued Life Activities Scale
Measured: 0, 10 weeks, 28 weeks, 56 weeks after randomisation
Change of global health
Single question to indicate perceived change in global health compared with last assessment visit
Measured: 10 weeks, 28 weeks, 56 weeks after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2017
- Study start5 Sep 2017
- Primary completion2 Nov 2020
- Study completion2 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 368 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Collaborators
- Versus Arthritis
- Responsible party
- Sponsor
- Investigators
- Gary Macfarlane, PhD, Principal investigator, University of AberdeenNeil Basu, MBChB, PhD, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03248518
- Sponsor's protocol ID
- 2.049.16
- Other IDs
- Epi029
- Acronym
- LIFT
- Status last verified
- Sep 2021
- First submitted
- 15 Feb 2017
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39257857Bachmair 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.
PubMed 36388001Martin 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.
PubMed 30705244
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases: A Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT03248518
- Acronym / sponsor ID
- LIFT / 2.049.16
- Conditions
- Rheumatoid Arthritis, Lupus Erythematosus, Systemic, Axial Spondyloarthritis, Psoriatic Arthritis, Sjogren's Syndrome
- Keywords
- Inflammatory Rheumatic Disease, Fatigue, Exercise, Behavioural Intervention, Rheumatoid Arthritis, Systemic Lupus Erythematosus, Axial Spondyloarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 368 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Collaborators
- Versus Arthritis
- Study start
- 5 Sep 2017 (actual)
- Primary completion
- 2 Nov 2020 (actual)
- Study completion
- 2 Nov 2020 (actual)
- First posted
- 14 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Eligible participants will be identified from patients with inflammatory rheumatic diseases attending major secondary care rheumatology services in the United Kingdom. Potential participants will be identified using local databases/clinic lists and will then be mailed a pre-study invite, which will include questions about fatigue. Potentially eligible participants will be invited to attend a baseline assessment.
Once it has been confirmed at the baseline assessement that they are eligible to take part in the study, the consented participant will be allocated to one of three treatment groups. During the course of the trial, the participant will be invited to visit the study centre three more times for assessments.
At each of the four assessment visits (baseline, and approximately 2, 7 and 13 months after) they will be asked:
- To complete questionnaires which collect information about various outcomes which we think will improve in response to the therapies under evaluation as well as factors which will help us understand how the treatments may work, and factors which may help identify those patients better suited to one therapy over another
- To provide a blood sample for research
- To take part in an aerobic fitness test
- To wear an activity monitor for the next 7 days which will be fitted at each visit
- To answer three short questions about engagement with intervention delivered by telephone from trial office at the time of session 4 and 8 (CBA and PEP intervention only). Similarly, the allocated therapists will be asked to give their view of the participants' engagement with the intervention.
All participants will be asked to keep a diary on any other treatments they are using in addition to the treatments they may receive during the study and how costly these other treatments are. The diary period will last for the first 6 months and then for 2 weeks after the third visit and 2 weeks before the last visit.
After they finished the study, the investigators may approach a subgroup of participants who received either the talking therapy or the personalised exercise programme again and ask for an interview to enable more detailed feedback on if they found the intervention helpful and how it has changed their daily life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care alone | Active comparator | Behavioral: Usual CareParticipants receive written information about fatigue which is designed as self-management guide. |
| CBA + usual care | Active comparator | Behavioral: Usual Care, Behavioral: Cognitive behavioural approachIn 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 comparator | Behavioral: Usual Care, Behavioral: Personalised Exercise ProgrammeIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual CareInformation booklet on fatigue which represents usual care in almost all UK rheumatology centres | Behavioural | CBA + usual care, PEP + usual care, Usual Care alone |
| Cognitive behavioural approachAlso: CBAA talking therapy which explicitly aims to replace unhelpful beliefs and behaviours through the application of patient-centred strategies and behavioural activities | Behavioural | CBA + usual care |
| Personalised Exercise ProgrammeAlso: PEPPEP 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. | Behavioural | PEP + usual care |
Primary outcome
Fatigue (severity) using Chalder Fatigue Scale (Likert)
Time frame: 56 weeks
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
Fatigue (severity) using Chalder Fatigue Scale (Likert)
Time frame: 10 weeks
Chalder Fatigue Scale (Likert), assessed at 10 weeks after baseline, between-group change CBA+UC vs UC and PEP+UC vs UC
Fatigue (severity) using Chalder Fatigue Scale (Likert)
Time frame: 28 weeks
Chalder Fatigue Scale (Likert), assessed at 28 weeks after baseline, between-group change CBA+UC vs UC and PEP+UC vs UC
Fatigue (impact) using Fatigue Severity Scale
Time frame: 56 weeks
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
Fatigue (impact) using Fatigue Severity Scale
Time frame: 10 weeks
Fatigue Severity Scale, co-primary outcome assessed at 10 weeks after baseline, between-group change CBA+UC vs UC and PEP+UC vs UC
Fatigue (impact) using Fatigue Severity Scale
Time frame: 28 weeks
Fatigue Severity Scale, co-primary outcome assessed at 28 weeks after baseline, between-group change CBA+UC vs UC and PEP+UC vs UC
7 secondary outcomes
Fatigue (physical, living, cognition and emotional aspects) using Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire
Time frame: 0, 10 weeks, 28 weeks, 56 weeks after randomisation
Quality of life & health utility index
Time frame: 0, 10 weeks, 28 weeks, 56 weeks after randomisation
Pain using numerical rating scale
Time frame: 0, 10 weeks, 28 weeks, 56 weeks after randomisation
Anxiety and depression using Hospital anxiety and depression scale
Time frame: 0, 10 weeks, 28 weeks, 56 weeks after randomisation
Impact on work using Work Productivity and Activity Impairment Questionnaire
Time frame: 0, 10 weeks, 28 weeks, 56 weeks after randomisation
Impact on activities using Valued Life Activities Scale
Time frame: 0, 10 weeks, 28 weeks, 56 weeks after randomisation
Change of global health
Time frame: 10 weeks, 28 weeks, 56 weeks after randomisation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Derived from this study: PubMed 39257857Gray 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.
- Derived from this study: PubMed 36388001Bachmair 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.
- Derived from this study: PubMed 30705244Martin 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.
- Click here for more information about this studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Macfarlane, PhD principal investigator
University of Aberdeen
Neil Basu, MBChB, PhD principal investigator
University of Glasgow
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioural approach and Personalised Exercise Programme in people with Rheumatoid Arthritis and Lupus Erythematosus, Systemic, run by University of Aberdeen at 6 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue (severity) using Chalder Fatigue Scale (Likert) (time frame: 56 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03248518, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.