Clinical trial NCT02631005: Walk With Ease Program For Patients With Systemic Lupus Erythematosus
Official title: Walk With Ease Program For Patients With Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Systemic Lupus Erythematosus
Keywords: systemic lupus erythematosus
exercise
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: North Carolina Translational and Clinical Sciences Institute
First posted: 2015-12-15
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Visual Analog Scale (VAS) Pain Score from Baseline to Six Weeks
timeFrame: 6 weeks
measure: Change in VAS Stiffness Score from Baseline to Six Weeks
timeFrame: 6 weeks
measure: Change in VAS Fatigue Score from Baseline to Six Weeks
timeFrame: 6 weeks
measure: Change in FACIT-Fatigue Score from Baseline to Six Weeks
timeFrame: 6 weeks
Secondary outcomes:
measure: Participant Satisfaction with Walk With Ease
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Rheumatology Clinic
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Saira Sheikh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Leigh Callahan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Katherine Kaufman, MD
role: PRINCIPAL_INVESTIGATOR
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