Lupus Intervention for Fatigue Trial

NCT02653287 | Active Not Recruiting DMC

• 1 other identifier: LIFT Study
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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). 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.

Conditions

Fatigue; Physical Activity; Lupus Erythematosus, Systemic

Keywords

Fatigue, Physical Activity, Lupus

Outcome Measures

Primary Outcomes (1)

• Change in Fatigue Severity Scale over time

  Online questionnaire

  Baseline, 3, 6, 12 months

Secondary Outcomes (3)

• Change in Physical Activity Scale over time

  Baseline, 3, 6, 12 months

• Change in International Physical Activity Questionnaire (IPAQ) over time

  Baseline, 3, 6, 12 months

• Godin Leisure Time Exercise Questionnaire

  Baseline, 6, 12 months

Other Outcomes (1)

• Change in Nutrition Data Systems for Research (NDSR) over time

  Baseline, 6, 12 months

Study Arms (2)

Intervention

EXPERIMENTAL

The 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.

Behavioral: Experimental

Control

ACTIVE COMPARATOR

The 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.

Other: Control

Interventions

Experimental BEHAVIORAL

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.

Intervention

Control OTHER

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.

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• include pregnancy at baseline

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (2)

Holly Milaeger

Chicago, Illinois, 60611, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (9)

• 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.

  PMID: 20656619 BACKGROUND

• 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.

  PMID: 26238554 BACKGROUND

• 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.

  PMID: 25251755 BACKGROUND

• 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.

  PMID: 21183562 BACKGROUND

• 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.

  PMID: 14635294 BACKGROUND

• 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.

  PMID: 22311939 BACKGROUND

• 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.

  PMID: 21135297 BACKGROUND

• 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.

  PMID: 20456590 BACKGROUND

• 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.

  PMID: 2803071 BACKGROUND

MeSH Terms

Conditions

Fatigue; Motor Activity; Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Rosalind Ramsey-Goldman, MD, DrPH

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 7, 2016
• First Posted: January 12, 2016
• Study Start: May 1, 2019
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (2)