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Clinical Trials/NCT02631005
NCT02631005
Completed
Not Applicable

Walk With Ease Program For Patients With Systemic Lupus Erythematosus

University of North Carolina, Chapel Hill1 site in 1 country76 target enrollmentMarch 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Systemic Lupus Erythematosus
Sponsor
University of North Carolina, Chapel Hill
Enrollment
76
Locations
1
Primary Endpoint
Change in VAS Stiffness Score from Baseline to Six Weeks
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2016
End Date
August 30, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Physician diagnosis of systemic lupus erythematosus
  • Age \>/= 18

Exclusion Criteria

  • Engagement in \>150 minutes of moderate-intensity activity at baseline
  • Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score \>8
  • Pregnancy

Outcomes

Primary Outcomes

Change in VAS Stiffness Score from Baseline to Six Weeks

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Change in Visual Analog Scale (VAS) Pain Score from Baseline to Six Weeks

Time Frame: 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.

Secondary Outcomes

  • Participant Satisfaction with Walk With Ease(6 weeks)

Study Sites (1)

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