Fatigue, Lupus Erythematosus, Systemic, Physical Activity
Conditions
Keywords
Fatigue, Physical Activity, Lupus
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.
Interventions
BEHAVIORALExperimental
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.
OTHERControl
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.
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fatigue Severity Scale over time | Baseline, 3, 6, 12 months | Online questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRosalind Ramsey-Goldman, MD, DrPH
Northwestern University
Outcome results
None listed