Walk With Ease Program For Patients With Systemic Lupus Erythematosus

Study Overview
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Brief Summary
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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
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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.

Official Title
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Walk With Ease Program For Patients With Systemic Lupus Erythematosus

Conditions
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Systemic Lupus Erythematosus

Intervention / Treatment
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* Other: Walk With Ease


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Walk With Ease Participants<br>Participants will receive a copy of the Walk With Ease workbook. This workbook provides guidance on walking safety and on how to start and maintain a regular walking program. It is designed to help participants increase their physical activity over a six-week period. Participants will complete self-reported outcomes questionnaires before and after completion of the program. | Other: Walk With Ease<br>* Six-week walking program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Visual Analog Scale (VAS) Pain Score from Baseline to Six 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. | 6 weeks | 
| Change in VAS Stiffness Score from Baseline to Six 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. | 6 weeks | 
| Change in VAS Fatigue Score from Baseline to Six 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. | 6 weeks | 
| Change in FACIT-Fatigue Score from Baseline to Six 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. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant Satisfaction with Walk With Ease | This survey was designed by the Arthritis Foundation to assess participant satisfaction. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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systemic lupus erythematosus, exercise