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临床试验/NCT04482400
NCT04482400已完成不适用

Reducing Sedentary Time Using an Innovative mHealth Intervention Among Total Knee Replacement Patients

University of South Carolina2 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2020年8月1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
83
试验地点
2
主要终点
Change in Objectively Measured (Actigraph) Sedentary Behavior at 5 months

研究概览

简要总结

The purpose of this study is to examine the effects of two technology interventions on health outcomes (e.g., physical activity, sedentary behavior, physical function, pain) after knee replacement at 2 and 5 months .

详细描述

Two 8 week technology interventions will be examined and consist of the use of an app and/or website and regular calls. Assessments to examine outcomes will be completed at baseline, as well as at 2 and 5 months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
40 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Be 40-79 years of age
  • Had unilateral knee replacement within last 12 months
  • Have an Android or iOS smartphone that is accessible and near them the majority of the day
  • Be willing to download the study applications on their smartphone
  • Spend at least 7 hours/day sitting
  • Be English speaking

排除标准

  • Have any contraindications to activity
  • Have a mobility limiting comorbidity
  • Have a scheduled surgery within the next 6 months
  • Do not have ≥4 days of valid accelerometer (>=10 hours) wear at baseline.

结局指标

主要结局

Change in Objectively Measured (Actigraph) Sedentary Behavior at 5 months

时间窗: 5 months - baseline

change in sedentary behavior (\<100 counts/minute) measured with Actigraph accelerometers between baseline and 6 months

Change in Objectively Measured (Actigraph) Sedentary Behavior at 2 months

时间窗: 2 months - baseline

change sedentary behavior (\<100 counts/minute) measured with Actigraph accelerometers between baseline and 3 months

次要结局

  • Change in WOMAC Pain Subscale(5 months after surgery)
  • Total physical activity measured by Actigraph accelerometers(5 months after surgery)
  • Change in physical function via chair stand test(5 months after surgery)
  • Change in Physical Function(5 months after surgery)
  • Adherence to NEAT!2 calls(2 months)
  • Adherence to NEAT!2 app(2 months)
  • Response to NEAT!2 prompts(2 months)

研究者

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

Christine A Pellegrini, PhD

Assistant Professor

University of South Carolina

研究点 (2)

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