The Use of Samsung Health and ECG M-Trace Base II Applications in the Secondary Prevention After Stroke
2021年3月26日 更新者:Poznan University of Medical Sciences
The Use of Samsung Health and ECG M-Trace Base II Applications for the Assessment of Exercise Tolerance as the Secondary Prevention in Patients After Brain Stroke
The aim of the present study was to quantitatively assess the risk factors that may affect the re-occurrence of a CVD event and the use of a commercially available mobile application Samsung Health for the assessment of parameters of exercise tolerance and the ECG M-Trace Base II application for the assessment of cardiological parameters.
研究概览
详细说明
In the post-stroke group and in the control group, SMWT (Six Minute Walk Test) and SCT( Stair Climb Test) were preceded by a 10-minute rest in sitting position.
The time of test performance, the walked distance and steps made as well as the mean and maximum gait velocity and the calories burned were assessed using the above-mentioned Samsung Health application .
ECG results were assessed with the use of ECG M-Trace Base II application described above.
In addition, cardiological parameters such as: systolic blood pressure (SBP) and diastolic blood pressure (DBP), heart rate (HR) and arterial blood saturation were assessed.
The measurements were performed at rest and directly after SCMT and SCT.
Additionally, after the tests, the level of dyspnoea and fatigue was assessed according to the modified Borg scale (score 0-10).
研究类型
观察性的
注册 (实际的)
52
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
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Poznań、波兰、61-545
- Department of Rehabilitation and Physiotherapy Rehabilitation,
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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
42年 至 65年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
取样方法
非概率样本
研究人群
The study group (post-stroke) consisted of 26 patients (mean age 54.9±7.1) in whom ischaemic stroke occurred within 14 days before the admission to the Clinical Department.
The control group was composed of 26 healthy (mean age 55.6±6.1) individuals recruited from the hospital staff who did not experience stroke.
描述
Inclusion criteria to the post-stroke group were as follows :
- occurrence of hemiparesis after the first episode of ischaemic stroke
- stroke confirmed in the diagnostic imaging records
- score >3 on Lovett's scale of muscle strength in the paretic limbs
- score above 15 in Barthel's scale of performance in activities of daily living
- score below 12 in the National Institutes of Health Stroke Scale (NIHSS)
- available complete medical records concerning the assessed risk factors of recurrent CVD event
- lack of concomitant pulmonary diseases including chronic obstructive pulmonary disease and bronchial asthma
Exclusion criteria from the post-stroke group were as follows:
- hemiparesis or tetraparesis following many episodes of stroke,
- lack of diagnostic imaging scans confirming the occurrence of stroke
- hospital stay at the Department of Neurological Rehabilitation for more than 14 days from the occurrence of stroke
- incomplete medical records concerning the assessed risk factors of recurrent CVD event
- score >3 on Lovett's scale of muscle strength in the paretic limbs
- score below 14 in Barthel's scale of performance in activities of daily living
- score above 13 in the NIHSS scale
- occurrence of factors limiting walking ability, such as diagnosed pulmonary diseases, unstable angina, severe valvular heart diseases, cardiomyopathy, musculoskeletal or autoimmune diseases.
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
队列和干预
团体/队列 |
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The study group (post-stroke)
The study group consisted of 26 patients in whom ischaemic brain stroke occurred within 14 days before the admission to the Clinical Department, and were hospitalised at the Department of Neurological Rehabilitation of the Clinical Department of Rehabilitation in the Wiktor Dega Orthopaedic and Rehabilitation Clinical Hospital in Poznań
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The control group
The control group was composed of 26 healthy individuals recruited from the hospital staff who did not experience stroke.
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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 |
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heart rate at rest
大体时间:baseline
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heart rate per minute
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baseline
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heart rate at rest
大体时间:3 weeks
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heart rate per minute
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3 weeks
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heart rate after SMWT
大体时间:baseline
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heart rate per minute
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baseline
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heart rate after SMWT
大体时间:3 weeks
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heart rate per minute
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3 weeks
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heart rate after SCT
大体时间:baseline
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heart rate per minute
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baseline
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heart rate after SCT
大体时间:3 weeks
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heart rate per minute
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3 weeks
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heart rhythm at rest
大体时间:baseline
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heart rhythm interpreting ECG (regular or irregular)
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baseline
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heart rhythm at rest
大体时间:3 weeks
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heart rhythm interpreting ECG (regular or irregular)
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3 weeks
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heart rhythm after SMWT
大体时间:baseline
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heart rhythm interpreting ECG (regular or irregular)
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baseline
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heart rhythm after SMWT
大体时间:3 weeks
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heart rhythm interpreting ECG (regular or irregular)
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3 weeks
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heart rhythm after SCT
大体时间:baseline
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heart rhythm interpreting ECG (regular or irregular)
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baseline
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heart rhythm after SCT
大体时间:3 weeks
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heart rhythm interpreting ECG (regular or irregular)
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3 weeks
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increased blood pressure at rest
大体时间:baseline
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blood pressure value [mm/Hg]
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baseline
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increased blood pressure at rest
大体时间:3 weeks
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blood pressure value [mm/Hg]
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3 weeks
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increased blood pressure after SMWT
大体时间:baseline
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blood pressure value [mm/Hg]
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baseline
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increased blood pressure after SMWT
大体时间:3 weeks
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blood pressure value [mm/Hg]
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3 weeks
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increased blood pressure after SCT
大体时间:baseline
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blood pressure value [mm/Hg]
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baseline
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increased blood pressure after SCT
大体时间:3 weeks
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blood pressure value [mm/Hg]
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3 weeks
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Distance of walk after SMWT
大体时间:baseline
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Distance (metres)
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baseline
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Distance of walk after SMWT
大体时间:3 weeks
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Distance (metres)
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3 weeks
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Distance of walk after SCT
大体时间:baseline
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Distance (metres)
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baseline
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Distance of walk after SCT
大体时间:3 weeks
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Distance (metres)
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3 weeks
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Steps after SMWT
大体时间:baseline
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Number of steps (number)
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baseline
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Steps after SMWT
大体时间:3 weeks
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Number of steps (number)
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3 weeks
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Steps after SCT
大体时间:baseline
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Number of steps (number)
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baseline
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Steps after SCT
大体时间:3 weeks
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Number of steps (number)
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3 weeks
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Velocity of walk after SMWT
大体时间:baseline
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Mean velocity (km/h)
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baseline
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Velocity of walk after SMWT
大体时间:3 weeks
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Mean velocity (km/h)
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3 weeks
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Velocity of walk after SCT
大体时间:baseline
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Mean velocity (km/h)
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baseline
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Velocity of walk after SCT
大体时间:3 weeks
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Mean velocity (km/h)
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3 weeks
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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:Ewa Chlebuś、Clinic Rehabilitation, University of Medical Sciences in Poznań
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)
2020年11月15日
初级完成 (实际的)
2021年3月1日
研究完成 (实际的)
2021年3月1日
研究注册日期
首次提交
2021年3月8日
首先提交符合 QC 标准的
2021年3月26日
首次发布 (实际的)
2021年3月29日
研究记录更新
最后更新发布 (实际的)
2021年3月29日
上次提交的符合 QC 标准的更新
2021年3月26日
最后验证
2021年3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.