NEAT!2 Sedentary Behavior Reduction for Individuals With Past or Present Knee Symptoms, Injuries, or Surgeries
2021年6月28日 更新者：Christine A Pellegrini, PhD、University of South Carolina
NEAT!2 Sedentary Behavior Reduction Intervention for Individuals With Past or Present Knee Symptoms, Injuries, or Surgeries
This study will evaluate the effectiveness of an mHealth sedentary reduction program over a 6-month period of time in adults with past or present knee symptoms, injuries, or surgeries.
研究概览
详细说明
Sedentary behavior, in excess, is associated with numerous health consequences including poor physical function.
Older adults with symptomatic knee pain spend the majority of their waking hours engaging in sedentary behaviors.
To reduce the risk of disability, improve quality of life, and prevent deterioration in physical function, it is imperative the investigators develop ways to reduce sedentary time.
Smartphone ownership among older adults is increasing and may provide a scalable opportunity to disseminate a sedentary reduction intervention.
Therefore, this study aims to evaluate and compare changes in sedentary behavior and physical function between an mHealth sedentary reduction, mHealth intervention plus coaching, and delayed mHealth group.
Sedentary behavior and physical function will be assessed at baseline, 1 month, 3 months, and 6 months after randomization.
研究类型
介入性
注册 (实际的)
11
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
South Carolina
-
Columbia、South Carolina、美国、29208
- University of South Carolina
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
40年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Be at least 40 years of age
- Own an Android or Apple smartphone
- Have their smartphone near them (in their pocket, in their hand, or within 10 feet of them) for >50% of their waking day
- Be willing to download the study application and be compatible on their smartphone
- Spend at least 7 hours/day sitting
- Have at least 4 days of valid accelerometer data at baseline
- Have knee pain (at least one knee with pain, aching, or stiffness on most days for one month of the last 12 months), knee injury, or knee replacement within the last 5 years
- Read, speak, and understand English
Exclusion Criteria:
- Have any contraindications to activity
- Have a mobility limiting comorbidity
- Have a scheduled surgery within the next 6 months
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：NEAT!2
Participants will be asked to use the NEAT!2 app for 3 months after randomization.
App use between 4-6 months is optional.
|
Participants randomized to NEAT!2 will have their NEAT!2 app turned on after randomization.
When 30 minutes of continuous non-movement or sedentary time is detected, the NEAT!2 app will provide a vibration or audio notification as well as display a reminder on the phone's lock/home screen.
Participants will be asked to use the app for the 3 months of the intervention.
Participants will be given an initial goal to reduce total sedentary time by 30 minutes/day, ultimately progressing to a 90 minute/day reduction by 3 months.
After the 3-month assessment, participants randomized to NEAT!2 will have the option to continue using the app until 6 months.
|
|
实验性的：NEAT!2+Calls
Participants will be asked to use the NEAT!2 app for 3 months after randomization.
In addition, participants will receive bi-weekly coaching calls over 3 months.
App use between 4-6 months is optional.
|
Participants in this group will have their NEAT!2 app turned on after randomization.
In addition, to receiving the identical app and given the same goals as participants randomized to NEAT!2, NEAT!2+Calls participants will receive 10-15 minute bi-weekly coaching calls.
After the 3-month assessment, participants will have the option to continue using the app until 6 months.
During this time, participants will not receive any coaching calls.
|
|
其他：Delayed NEAT!2
Participants will receive the NEAT!2 app to use between 3 and 6 months.
|
Participants randomized to Delayed NEAT!2 will not receive any contact or app between baseline and 3 months.
However, after completing the 3-month assessment, participants will receive the NEAT!2 application.
Participants will then have the option to use the app between 3 and 6 months.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Sedentary Behavior at 1 Month
大体时间：Baseline to 1 month
|
Daily sedentary behavior objectively measured by activpal
|
Baseline to 1 month
|
|
Change in Sedentary Behavior at 3 Months
大体时间：Baseline to 3 months
|
Daily sedentary behavior objectively measured by activpal
|
Baseline to 3 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Timed Up & Go at 1 Month
大体时间：Baseline to 1 month
|
Physical function assessed by Timed Up & Go (seconds)
|
Baseline to 1 month
|
|
Change in Chair Stands at 1 Month
大体时间：Baseline to 1 month
|
Physical function assessed by Chair Stand Test (# stands in 30 seconds)
|
Baseline to 1 month
|
|
Change in 6 Minute Walk at 1 Month
大体时间：Baseline to 1 month
|
Physical function assessed by 6 minute walk (total feet)
|
Baseline to 1 month
|
|
Change in Timed Up & Go at 3 Months
大体时间：Baseline to 3 months
|
Physical function assessed by Timed Up & Go (seconds)
|
Baseline to 3 months
|
|
Change in Chair Stands at 3 Months
大体时间：Baseline to 3 months
|
Physical function assessed by Chair Stand Test (# stands in 30 seconds)
|
Baseline to 3 months
|
|
Change in 6 Minute Walk at 3 Months
大体时间：Baseline to 3 months
|
Physical function assessed by 6 minute walk (total feet)
|
Baseline to 3 months
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Maintenance of Changes in Sedentary Behavior at 6 Months
大体时间：Baseline to 6 months
|
Daily sedentary behavior objectively measured by activpal
|
Baseline to 6 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年6月22日
初级完成 (实际的)
2020年9月9日
研究完成 (实际的)
2020年9月9日
研究注册日期
首次提交
2019年6月12日
首先提交符合 QC 标准的
2019年6月14日
首次发布 (实际的)
2019年6月17日
研究记录更新
最后更新发布 (实际的)
2021年7月19日
上次提交的符合 QC 标准的更新
2021年6月28日
最后验证
2021年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.