Lupus Intervention for Fatigue Trial

Not Applicable

Active, not recruiting

• Conditions: Physical Activity; Lupus Erythematosus, Systemic; Fatigue

• Registration Number: NCT02653287
• Lead Sponsor: Northwestern University

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.

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.

Study Timeline

• Study First Submitted: 2016-01-07
• Study First Submitted QC: 2016-01-11
• Study First Posted: 2016-01-12
• Study Start: 2019-05-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-06
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Fatigue Severity Scale over time	Baseline, 3, 6, 12 months	Online questionnaire

Secondary Outcome Measures

Name	Time	Method
Change in Physical Activity Scale over time	Baseline, 3, 6, 12 months	Accelerometry
Change in International Physical Activity Questionnaire (IPAQ) over time	Baseline, 3, 6, 12 months	Phone Interview Questionnaire
Godin Leisure Time Exercise Questionnaire	Baseline, 6, 12 months	Phone Interview Questionnaire

Trial Locations

Locations (2)

Holly Milaeger; 🇺🇸 Chicago, Illinois, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States