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Use of Wearable Tech to Increase Physical Activity in Inpatient Rehabilitation for Patients With Chronic Pain

The aim of this project is to evaluate whether use of wearable tech increases levels of physical activity in patients participating in inpatient rehabilitation for chronic pain.

研究概览

详细说明

Chronic pain is a vast problem with profound consequences for individuals and societies. Exercise and physical activity is an important part of the treatment for chronic pain. Use of wearable tech might be a way to help facilitate physical activity in patients with chronic pain. Here it will be evaluated whether use of wearable tech giving feedback about the user's activity level increases physical activity in patients participating in inpatient rehabilitation for chronic pain. The control group will be wearing the same wearable tech as the intervention group, but they will not receive any feedback about their activity level.

The feedback application will give participants in the intervention group information about the number of PAI they earn each week. PAI is short for personal activity Intelligence. You earn PAI points every time your heart rate increases: The higher heart rate, the faster you earn PAI. Previous research have shown that those who achieve 100 PAI or more every week over time live for an average of more than eight years longer than others.

During the study all participants will take part in a traditional inpatient rehabilitation program. The program consist of two periods at the rehabilitation center with two weeks at home in-between. The study will take place during the two periods at the senter and the period at home. Time spent on physical activity and number of earned PAI's will be counted during the period at home.

研究类型

介入性

注册 (实际的)

44

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

      • Rissa、挪威
        • Unicare Helsefort

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

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • taking part in inpatient rehabilitation at Unicare Helefort Rehabilitation center for chronic pain.

Exclusion Criteria:

  • not having a smartphone (will not be able to access the mobile application).
  • using a wheelchair (the technology will be not able to measure activity correctly)

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:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器:没有反馈的可穿戴技术
该组将佩戴与干预组相同的活动测量设备,但他们不会收到有关其活动水平的任何反馈。 他们将无法访问移动应用程序。 他们将参加与干预组相同的康复计划。
traditional inpatient rehabilitation program.
An armwrist device measuring physical activity level, no reporting back to the user.
实验性的:Wearable tech with feedback
This group will be wearing an activity measurement device (wristband) and receive feedback about their activity level through a mobile application while taking part in a traditional inpatient rehabilitation program for patients with chronic pain.
An armwrist device measuring physical activity level. The user will receive information about their physical activity level through their smartphone.
traditional inpatient rehabilitation program.

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
Activity level
大体时间:2 weeks (time period at home between two stays at the rehabilitation center)
Time spent in moderate to vigorous physical activity (minutes per day)
2 weeks (time period at home between two stays at the rehabilitation center)
Number of PAIs
大体时间:2 weeks (time period at home between two stays at the rehabilitation center)
mean number of Personal Activity Intelligence (PAI) points achieved per week
2 weeks (time period at home between two stays at the rehabilitation center)
Percentage achieving 100 PAIs per week
大体时间:2 weeks (time period at home between two stays at the rehabilitation center)
Personal Activity Intelligence (PAI)
2 weeks (time period at home between two stays at the rehabilitation center)

次要结果测量

结果测量
措施说明
大体时间
oxygen uptake
大体时间:6 weeks (from inclusion to end of rehabilitation program)
submaximal oxygen uptake measured by the Åstrand bicycle test (described in Textbook of work physiology by Astrand from 1986)
6 weeks (from inclusion to end of rehabilitation program)
Anxiety and depression symptoms
大体时间:6 weeks (from inclusion to end of rehabilitation program)
HSCL-25 questionnaire
6 weeks (from inclusion to end of rehabilitation program)
Average pain
大体时间:6 weeks (from inclusion to end of rehabilitation program)
Visual Analogue Scale (VAS). VAS is a straight horizontal line where the ends are defined as the extreme limits from the left (0-no pain) to the right (100-worst imaginable pain). The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain.
6 weeks (from inclusion to end of rehabilitation program)
Health related quality of life
大体时间:6 weeks (from inclusion to end of rehabilitation program)
EQ5D questionnaire
6 weeks (from inclusion to end of rehabilitation program)
Body weight
大体时间:6 weeks (from inclusion to end of rehabilitation program)
body weight in kilograms
6 weeks (from inclusion to end of rehabilitation program)
Body Mass Index score
大体时间:6 weeks (from inclusion to end of rehabilitation program)
weight in kilograms divided by height in metres squared
6 weeks (from inclusion to end of rehabilitation program)

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。

调查人员

  • 首席研究员:Lene Aasdahl, PhD MD、National Taiwan Normal University
  • 研究主任:Jorunn Helbostad, Dr Philos、Norwegian University of Science and Technology

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8月8日

初级完成 (实际的)

2020年1月14日

研究完成 (实际的)

2020年1月14日

研究注册日期

首次提交

2019年7月22日

首先提交符合 QC 标准的

2019年7月22日

首次发布 (实际的)

2019年7月24日

研究记录更新

最后更新发布 (实际的)

2020年1月27日

上次提交的符合 QC 标准的更新

2020年1月24日

最后验证

2020年1月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2019/800

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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