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Walk With Ease Program For Patients With Systemic Lupus Erythematosus (Walk SLE)

Primary Purpose

Systemic Lupus Erythematosus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
"Walk With Ease"
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring systemic lupus erythematosus, exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UNC Rheumatology Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Walk With Ease Participants

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Participant Satisfaction with Walk With Ease
This survey was designed by the Arthritis Foundation to assess participant satisfaction.

Full Information

First Posted
December 11, 2015
Last Updated
October 11, 2018
Sponsor
University of North Carolina, Chapel Hill
Collaborators
North Carolina Translational and Clinical Sciences Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02631005
Brief Title
Walk With Ease Program For Patients With Systemic Lupus Erythematosus
Acronym
Walk SLE
Official Title
Walk With Ease Program For Patients With Systemic Lupus Erythematosus
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
August 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
North Carolina Translational and Clinical Sciences Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
systemic lupus erythematosus, exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Walk With Ease Participants
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
"Walk With Ease"
Intervention Description
Six-week walking program
Primary Outcome Measure Information:
Title
Change in Visual Analog Scale (VAS) Pain Score from Baseline to Six Weeks
Description
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.
Time Frame
6 weeks
Title
Change in VAS Stiffness Score from Baseline to Six Weeks
Description
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.
Time Frame
6 weeks
Title
Change in VAS Fatigue Score from Baseline to Six Weeks
Description
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.
Time Frame
6 weeks
Title
Change in FACIT-Fatigue Score from Baseline to Six Weeks
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Participant Satisfaction with Walk With Ease
Description
This survey was designed by the Arthritis Foundation to assess participant satisfaction.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saira Sheikh, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Leigh Callahan, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Katherine Kaufman, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNC Rheumatology Clinic
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27517
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Walk With Ease Program For Patients With Systemic Lupus Erythematosus

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