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FatigueLIFTNCT02653287

Lupus Intervention for Fatigue Trial

A study testing Experimental in people with Fatigue and Physical Activity, run by Northwestern University at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Participants in the Chicago Lupus Database or individuals seen at Northwestern Medicine will be approached to enroll in a one year clinical trial looking at decreasing fatigue in persons with systemic lupus erythematosus (SLE). Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Experimental
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
2 sitesUnited States
Study dates
1 May 2019to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • include meeting at least 4 of 11 American College of Rheumatology (ACR) classification criteria for definite SLE, or 3 out of 11 ACR classification criteria with also meeting at least one SLICC criteria
  • be at least 18 years of age
  • have a BMI between 18-40 kg/m2
  • be able to ambulate at least household distances (50ft)
  • be able to provide informed consent.
  • be able to speak and read English

Who cannot join

  • include pregnancy at baseline
  • not meeting inclusion criteria.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Holly Milaeger

    Chicago, Illinois, 60611

  • Northwestern University

    Chicago, Illinois, 60611

Other trials in United States

About this study

Participants in the Chicago Lupus Database or individuals seen at Northwestern Medicine will be approached to enroll in a one year clinical trial looking at decreasing fatigue in persons with systemic lupus erythematosus (SLE). The intervention group will receive individual coaching sessions focusing on physical activity and nutrition while the control group will receive individual calls in relation to SLE self-management educational sessions.This study is designed to evaluate the LIFT intervention to decrease fatigue (primary outcome), improve physical activity (secondary outcome) and dietary behavior (exploratory outcome) in persons with SLE.

Read the detailed description

Participants in the Chicago Lupus Database or individuals seen at Northwestern Medicine will be approached to enroll in a one year clinical trial looking at decreasing fatigue in persons with systemic lupus erythematosus (SLE). The intervention group will receive individual coaching based in motivational interviewing sessions focusing on physical activity and nutrition while the control group will receive individual calls focusing on SLE self-management. This study is designed to evaluate the LIFT intervention to decreased fatigue (primary outcome), improve physical activity (secondary outcome) and dietary behavior (exploratory outcome) in persons with SLE.

Being tested
Experimental, Control
Keywords
Fatigue, Physical Activity, Lupus
Medical subject headings
Fatigue, Motor Activity, Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExperimentalBehavioural

    The experimental intervention includes 4 individual coaching sessions (initial 1 hour in-person and remaining 10-15 minutes per telephone) designed to identify barriers and supports for physical activity and nutrition using motivational interviewing. They occur shortly after randomization, 1.5, 3, and 6 months. Daily participants monitor their physical activity via the Fitbit Flex and their dietary behavior on a paper diary.

  • ControlOther

    The control group will receive four individual phone calls focusing on education for SLE disease management, as well as answering any questions the participants have about the study. Topics include: what is lupus, laboratory tests, medications, taking charge of your health care and managing stress (2 sessions). Each call will last about 10-15 minutes, and occur shortly after randomization, then at 1.5, 3, and 6 months.

Study groups in NCT02653287
Study groupRoleWhat they receive
InterventionExperimentalThe experimental intervention is a unique combination of four individual counseling sessions based in motivational interviewing focusing on physical activity, dietary behavior and behavioral strategies. The individual sessions will provide a tailored personalized intervention including problem-solving and goal setting for increasing physical activity, and following a healthy diet. Healthy Lifestyle Coaches (RN or MPH) will be responsible for conducting the individual for a caseload of participants. There are no drugs involved in the intervention.
Receives: Behavioral: Experimental
ControlActive comparatorThe control group intervention will receive four individual phone calls checking in with participants regarding questions about the study or from the educational sessions focusing on SLE disease management, each lasting approximately 10-15 minutes.
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Fatigue Severity Scale over time

    Online questionnaire

    Measured: Baseline, 3, 6, 12 months

Secondary outcomes (3)

  1. Change in Physical Activity Scale over time

    Accelerometry

    Measured: Baseline, 3, 6, 12 months

  2. Change in International Physical Activity Questionnaire (IPAQ) over time

    Phone Interview Questionnaire

    Measured: Baseline, 3, 6, 12 months

  3. Godin Leisure Time Exercise Questionnaire

    Phone Interview Questionnaire

    Measured: Baseline, 6, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2016 (estimated)
  2. Study start1 May 2019
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02653287
Sponsor's protocol ID
LIFT Study
Acronym
LIFT
Status last verified
Apr 2026
First submitted
7 Jan 2016
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: It is the intent of all investigators in this project to share any and all resources generated as a result of an award for this project. The final data from this project will be de-identified in accordance with HIPAA guidelines.

Publications

  • Ramsey-Goldman R, Rothrock N. Fatigue in systemic lupus erythematosus and rheumatoid arthritis. PM R. 2010 May;2(5):384-92. doi: 10.1016/j.pmrj.2010.03.026.

    PubMed 20656619

  • del Pino-Sedeno T, Trujillo-Martin MM, Ruiz-Irastorza G, Cuellar-Pompa L, de Pascual-Medina AM, Serrano-Aguilar P; Spanish Systemic Lupus Erythematosus CPG Development Group. Effectiveness of Nonpharmacologic Interventions for Decreasing Fatigue in Adults With Systemic Lupus Erythematosus: A Systematic Review. Arthritis Care Res (Hoboken). 2016 Jan;68(1):141-8. doi: 10.1002/acr.22675.

    PubMed 26238554

  • Ahn GE, Chmiel JS, Dunlop DD, Helenowski IB, Semanik PA, Song J, Ainsworth B, Chang RW, Ramsey-Goldman R. Self-reported and objectively measured physical activity in adults with systemic lupus erythematosus. Arthritis Care Res (Hoboken). 2015 May;67(5):701-7. doi: 10.1002/acr.22480.

    PubMed 25251755

  • Mancuso CA, Perna M, Sargent AB, Salmon JE. Perceptions and measurements of physical activity in patients with systemic lupus erythematosus. Lupus. 2011 Mar;20(3):231-42. doi: 10.1177/0961203310383737. Epub 2010 Dec 23.

    PubMed 21183562

  • Ramsey-Goldman R, Schilling EM, Dunlop D, Langman C, Greenland P, Thomas RJ, Chang RW. A pilot study on the effects of exercise in patients with systemic lupus erythematosus. Arthritis Care Res. 2000 Oct;13(5):262-9. doi: 10.1002/1529-0131(200010)13:53.0.co;2-8.

    PubMed 14635294

  • Davies RJ, Lomer MC, Yeo SI, Avloniti K, Sangle SR, D'Cruz DP. Weight loss and improvements in fatigue in systemic lupus erythematosus: a controlled trial of a low glycaemic index diet versus a calorie restricted diet in patients treated with corticosteroids. Lupus. 2012 May;21(6):649-55. doi: 10.1177/0961203312436854. Epub 2012 Feb 6.

    PubMed 22311939

  • Lin JS, O'Connor E, Whitlock EP, Beil TL. Behavioral counseling to promote physical activity and a healthful diet to prevent cardiovascular disease in adults: a systematic review for the U.S. Preventive Services Task Force. Ann Intern Med. 2010 Dec 7;153(11):736-50. doi: 10.7326/0003-4819-153-11-201012070-00007.

    PubMed 21135297

  • Delahanty LM. Research charting a course for evidence-based clinical dietetic practice in diabetes. J Hum Nutr Diet. 2010 Aug;23(4):360-70. doi: 10.1111/j.1365-277X.2010.01065.x. Epub 2010 Apr 27.

    PubMed 20456590

  • Krupp LB, LaRocca NG, Muir-Nash J, Steinberg AD. The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol. 1989 Oct;46(10):1121-3. doi: 10.1001/archneur.1989.00520460115022.

    PubMed 2803071

Questions about this trial

What is this clinical trial studying?

A study testing Experimental in people with Fatigue and Physical Activity, run by Northwestern University at 2 sites in United States.

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 6 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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?

This study is still under way. Results are not available in the source record yet.

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?

Change in Fatigue Severity Scale over time (time frame: Baseline, 3, 6, 12 months). 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 NCT02653287, which also lists 9 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 13 Apr 2026.

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