Virtual Group Motivation in Exercise Treadmill Testing
2018年10月10日 更新者：Urs Hufschmid、Kantonsspital Baden
The Impact of Virtual Group Motivation on the Performance and Comfort of Patients in Exercise Treadmill Testing: A Randomized, Open Label Trial
Exercise stress testing is the most frequently used clinical tool for assessment of coronary artery disease.
To ensure a high validity of the results, a good Patient compliance is crucial.
The aim of this study is to examine the effects of a virtually presented exercise group on the perceived comfort and the exercise capacity of patients during classical treadmill exercise testing.
The investigators hypothesis is, that a virtually presented running group will increase the comfort of patients and their exercise capacity.
研究概览
详细说明
108 Patients were randomized in an open label trial 1:1 to either exercise treadmill testing while watching a static image of a flower (image group) or to exercise treadmill testing while watching a video of 5 amateur runners, running across and fields, giving the patient the impression of running within the group (video group). After the exercise test patients were asked to score their perceived comfort level and achieved level of their subjective physical limit on a 10 point scale.
Standard exercise treadmill parameters, as well as baseline demographic data were recorded of each patient. Patients with missing data was excluded of the analysis.
Statistic analysis was performed with t-test for normally distributed data and Wilcoxon-Mann-Whitney-Test for non-normal data.
研究类型
介入性
注册 (实际的)
108
阶段
- 不适用
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
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- indication for exercise stress testing
Exclusion Criteria:
- any contraindication for exercise stress testing
- unability of performing an exercise treadmill test
- recent surgery
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：诊断
- 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 |
|---|---|
|
无干预：Image Group
The patients were looking at a static image of a lavender flower while exercising on the treadmill.
|
|
|
实验性的：Video Group
The patients were watching a video of a group of amateur runners while exercising on the treadmill.
|
A video of a group of five amateur runners running along woods and fields.
The group was filmed from behind to give the patient the impression of running within the group.
|
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 |
|---|---|---|
|
Patients' performance
大体时间：Day of Exercise Testing
|
Patients' performance in metabolic equivalents percentage of age predicted maximum
|
Day of Exercise Testing
|
|
Patients' comfort
大体时间：Day of Exercise Testing
|
Subjective level of comfort of patient during the exercise test rated on a 10 point scale.
Scale ranges from 1 to 10. 10 indicates that the patient felt absolutely comfortable during the test, 1 indicates that the patient did not feel comfortable at all.
|
Day of Exercise Testing
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Exercise test duration
大体时间：Day of Exercise Testing
|
Exercise test duration in min:sec
|
Day of Exercise Testing
|
|
Age predicted heart rate
大体时间：Day of Exercise Testing
|
achieved percentage of age predicted heart rate
|
Day of Exercise Testing
|
|
physical limits
大体时间：Day of Exercise Testing
|
Achieved subjective level of physical limit rated on a 10 point scale.
Scale ranges from 1 to 10, 10 indicates that the patient subjectively reached his physical Limit, 1 indicates that the patient did not reach his physical limit at all.
The higher the value the more did the patient reach his physical limit (the better the outcome).
|
Day of Exercise Testing
|
|
rate pressure product increase
大体时间：Day of Exercise Testing
|
increase of the rate pressure product during the test
|
Day of Exercise Testing
|
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
- 研究主任：Jürg Hans Beer, Prof.、Head of the Department of Internal Medicine
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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)
2014年7月7日
初级完成 (实际的)
2014年9月26日
研究完成 (实际的)
2014年9月26日
研究注册日期
首次提交
2018年9月10日
首先提交符合 QC 标准的
2018年10月10日
首次发布 (实际的)
2018年10月12日
研究记录更新
最后更新发布 (实际的)
2018年10月12日
上次提交的符合 QC 标准的更新
2018年10月10日
最后验证
2018年10月1日
更多信息
与本研究相关的术语
其他研究编号
- ErgoTrial
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
未定
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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.
Video Group的临床试验
-
The University of Texas Health Science Center,...完全的
-
Radboud University Medical CenterZonMw: The Netherlands Organisation for Health Research and Development招聘中
-
Université Blaise Pascal, Clermont-Ferrand撤销
-
Centro Hospitalar do PortoUniversity of Trás-os-Montes and Alto Douro; Foundation for Science and Technology, Portugal; Institute...招聘中