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Completed

NCT Number: NCT02631005

Walk With Ease Program For Patients With Systemic Lupus Erythematosus

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.

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Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Behavior Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Motor Activity Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNC Rheumatology Clinic

Chapel Hill, North Carolina, 27517, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

"Walk With Ease"

Other

Six-week walking program

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Participant Satisfaction with Walk With Ease

    Time frame: 6 weeks

    This survey was designed by the Arthritis Foundation to assess participant satisfaction.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • North Carolina Translational and Clinical Sciences Institute

Registry information

Acronym: Walk SLE

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 15, 2015
Registry last updated
Oct 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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