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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 Carolina1 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
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
83
试验地点
1
主要终点
Objectively Measured (Actigraph) Sedentary Behavior at 2 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
是

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.

研究组 & 干预措施

NEAT!2

Experimental

Participants randomized to this arm will use the NEAT!2 app and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.

干预措施: NEAT!2 (Behavioral)

MyKneeGuide

Active Comparator

Participants randomized to this arm will use the MyKneeGuide app/website and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.

干预措施: MyKneeGuide (Behavioral)

结局指标

主要结局

Objectively Measured (Actigraph) Sedentary Behavior at 2 Months

时间窗: 2 months

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

Objectively Measured (Actigraph) Sedentary Behavior at 5 Months

时间窗: 5 months

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

次要结局

  • Adherence to NEAT!2 App(2 months)
  • Adherence to Calls(2 months)
  • Physical Function(5 months after surgery)
  • WOMAC Pain Subscale(5 months after surgery)
  • Total Physical Activity Measured by Actigraph Accelerometers(5 months after surgery)
  • Response to NEAT!2 Prompts(2 months)
  • Physical Function Via Chair Stand Test(5 months after surgery)

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 (1)

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