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Lupus Intervention for Fatigue Trial
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 assess 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
🗓️ Study Start (Actual) 1 May 2019
🗓️ Primary Completion (Estimated) December 2024
✅ Study Completion (Estimated) December 2024
👥 Enrollment (Estimated) 200
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Chicago, Illinois, United States
📍 Chicago, Illinois, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * 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

    Exclusion Criteria:

    • * include pregnancy at baseline
    • * not meeting inclusion criteria.
Ages Eligible for Study: 18 Years to 80 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 7 January 2016
  • First Submitted that Met QC Criteria 11 January 2016
  • First Posted 12 January 2016

Study Record Updates

  • Last Update Submitted that Met QC Criteria 21 February 2024
  • Last Update Posted 22 February 2024
  • Last Verified February 2024
I'm interested ...!!