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临床试验/NCT02631005
NCT02631005已完成不适用

Walk With Ease Program For Patients With Systemic Lupus Erythematosus

University of North Carolina, Chapel Hill2 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2016年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
76
试验地点
2
主要终点
Change in VAS Stiffness Score from Baseline to Six Weeks

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

Walk With Ease Participants

Experimental

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.

干预措施: "Walk With Ease" (Other)

结局指标

主要结局

Change in VAS Stiffness Score from Baseline to Six Weeks

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • Participant Satisfaction with Walk With Ease(6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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