Systemic Lupus Erythematosus
Conditions
Keywords
systemic lupus erythematosus, exercise
Brief summary
The purpose of this study is to evaluate the effects of Walk With Ease, a moderate-intensity exercise program, on pain, stiffness, and fatigue caused by lupus. Participants will receive a copy of the Walk With Ease workbook. The book provides guidance about walking safety as well as how to start, build-up, and maintain a walking program. Participants will complete questionnaires assessing their symptoms before and after completing the six-week program.
Detailed description
The purpose of this study is to evaluate the effects of Walk With Ease, a moderate-intensity exercise program, on pain, stiffness, and fatigue caused by lupus. Participants will receive a copy of the Walk With Ease workbook, a publication of the Arthritis Foundation. Participants will complete self-reported outcomes questionnaires prior to beginning the program and six weeks later at completion of the program. The questionnaires will include visual analog scales for pain, stiffness, and fatigue as well as a FACIT-Fatigue form. Participants will also complete a satisfaction survey at the end of the program.
Interventions
OTHERWalk With Ease
Six-week walking program
Sponsors
North Carolina Translational and Clinical Sciences Institute
University of North Carolina, Chapel Hill
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Physician diagnosis of systemic lupus erythematosus * Age \>/= 18
Exclusion criteria
* Age \<18 * Engagement in \>150 minutes of moderate-intensity activity at baseline * Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score \>8 * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Visual Analog Scale (VAS) Pain Score from Baseline to Six Weeks | 6 weeks | Pain scale ranges from 0 millimeters (mm) (no pain) to 100 mm (worst pain imaginable). An increase in score indicates worsening pain, while a decrease represents a response to the intervention. |
| Change in VAS Stiffness Score from Baseline to Six Weeks | 6 weeks | Stiffness scale ranges from 0 millimeters (mm) (no stiffness) to 100 mm (worst stiffness imaginable). An increase in score indicates worsening stiffness, while a decrease represents a response to the intervention. |
| Change in VAS Fatigue Score from Baseline to Six Weeks | 6 weeks | Fatigue scale ranges from 0 millimeters (mm) (no fatigue) to 100 mm (worst fatigue imaginable)An increase in score indicates worsening fatigue, while a decrease represents a response to the intervention. |
| Change in FACIT-Fatigue Score from Baseline to Six Weeks | 6 weeks | This 13-item scale assesses levels of fatigue during daily activities over the past seven days. Higher scores indicate less fatigue (score range = 0 - 52). Positive change scores indicate improved fatigue. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant Satisfaction with Walk With Ease | 6 weeks | This survey was designed by the Arthritis Foundation to assess participant satisfaction. |
Countries
United States
Outcome results
None listed