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临床试验/NCT05287581
NCT05287581已完成不适用

A Progressive Home-based Exercise Intervention for Persons With Systemic Lupus Erythematosus

University of Michigan2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2022年1月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
2
主要终点
Change in physical activity over time

研究概览

简要总结

Physical activity and exercise are helpful for managing symptoms like fatigue in people living with systemic lupus erythematosus (lupus; SLE). Despite research supporting physical activity participation, people with lupus are often inactive and report being afraid to exercise. To that end, this project is a pilot randomized controlled trial for examining the efficacy of a home-based behavioral intervention based on social cognitive theory and motivational interviewing for increasing physical activity and decreasing fatigue.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

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

  • diagnosis of Lupus
  • be able to speak and read English
  • being non-active defined as not engaging in regular activity (150 minutes or more of moderate physical activity per week)
  • being impacted by fatigue defined as a score of 36 or higher on the fatigue severity scale

排除标准

  • moderate or high risk for undertaking physical activity

结局指标

主要结局

Change in physical activity over time

时间窗: Baseline and 4 months

Actigraph accelerometers will be worn by participants on an elastic belt around their waist for 7 days.

Change in Exercise over time

时间窗: Baseline, 2, 4, and 6 months

The Godin Leisure-Time Exercise Questionnaire (GLTEQ) will be administered. The GLTEQ measures the frequency of strenuous, moderate, and mild leisure activity performed for periods of 15 min or more over a usual week.

次要结局

  • Change in Fatigue Severity Scale over time(Baseline, 2, 4, and 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dominique Kinnett-Hopkins

Assistant Professor

University of Michigan

研究点 (2)

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