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Intelligent Cardiopulmonary Rehabilitation System for Patients With Chronic Stroke

2022年7月16日 更新者:Yen-Nung Lin、Taipei Medical University WanFang Hospital

Intelligent Cardiopulmonary Rehabilitation System for Patients With Chronic Stroke: a Feasibility Study

By comparing with traditional aerobic exercise training (TAET), we investigate the effects of an intelligent cardiopulmonary rehabilitative system (ICRS) on cardiopulmonary fitness and patient satification among patients with chronic stroke.

研究概览

地位

招聘中

条件

详细说明

Cycle ergometer training is one of the common indoor aerobic exercises for enhancing cardiorespiratory fitness in patients after stroke. However, studies had suggested that patients may be undertrained for reasons such as a tight time schedule for other rehabilitation programs and lack of objective evaluation on the training intensity.

To address the issue of inadequate cycle ergometer training in poststroke patients, in this study, an intelligent cardiopulmonary rehabilitation system was developed and incorporated into a bicycle ergometer, allowing dynamically auto-adjust paddling resistance considering the instant heart rate and cadence, with a goal to maintain the hear rate within the pre-determined heart rate zone. The purpose of the current study is to investigate the feasibility of the ICRS in stroke patients and whether it outweighs the traditional feedback on training intensity.

A single-blind crossover trial is adopted with 40 participants estimated to be recruited and randomly assigned to the group A and group B. Group A received training with ICRS while Group B received training with TAET at the beginning. The intensity of ICRS is set as 60%~80% heart rate reserve (HRR) which is obtained from cardiopulmonary exercise testing (CPET) at pretest. The intensity of TAET is set as subjective rating of perceived exertion at "somewhat hard" to "hard" level. Both groups will receive 30 minutes of training per session, 3 sessions a week for four weeks followed by a washout period of 4-week break. Subjects are crossed-over to the alternate treatment afterwards. CPET evaluations will be conducted in a total of 4 times before and after treatment.

研究类型

介入性

注册 (预期的)

40

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

      • New Taipei City、台湾
        • 招聘中
        • WanFang Hospital
        • 接触:

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

20年 至 75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

描述

Inclusion Criteria:

  • Aged 20-75 y/o
  • Healthy people
  • Chronic stroke > 6 months
  • Able to walk independently > 6 minutes with or without orthosis
  • Able to use stationary bike
  • MRS(Modified Rankin Scale) ranged 1 to 3

Exclusion Criteria:

  • Patients whose heart rate can not be used as the indicator of training intensity (eg, ar-rhythmia, atrial fibrillation, beta-blockers users)
  • With any reason that the patient is not suitable to undergo aerobic training
  • Patients who are unable to do cycling due to musculoskeletal problems
  • Patients who can not follow the instruction of trainers due to cognitive or emotional-problems.
  • Patients whose medical condition is not unstable.

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:交叉作业
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Intelligent cardiopulmonary rehabilitation system (ICRS)
The ICRS is very likely to the conventional stationary biking, but with an algorithm that automatically controls the resistance of pedalling, considering the instant heart rate and cadence, to keep the heart rate within the targeted heart rate zone.
Patients undergo 30-minute aerobic training with ICRS, 3 sessions a week, for 4 weeks.
有源比较器:Traditional aerobic exercise training (TAET)
The TAET is performed with stationary biking, with intensity being set as subjective rating of perceived exertion at a "somewhat hard" to "hard" level. The resistance of pedaling is ad-justed by the user or physical therapist.
Patients undergo 30-minute aerobic training with TAET, 3 sessions a week, for 4 weeks.

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
relative VO2-peak (mL/kg/min)
大体时间:4 weeks
oxygen consumption (VO2- peak) is measured during a the cardiopulmonary exercise test with a ramped stationary biking.
4 weeks

次要结果测量

结果测量
措施说明
大体时间
6-min walk test
大体时间:4 weeks
The 6-minute walk test measures the distance covered while walking at a tolerable pace for 6 minutes.
4 weeks
absolute VO2-peak (mL/min)
大体时间:4 weeks
oxygen consumption (VO2- peak) is measured during a the cardiopulmonary exercise test with a ramped stationary biking.
4 weeks
workload-peak (Watt)
大体时间:4 weeks
The peak workload is measured during a the cardiopulmonary exercise test with a ramped stationary biking.
4 weeks

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)

2022年1月25日

初级完成 (预期的)

2023年6月1日

研究完成 (预期的)

2023年8月1日

研究注册日期

首次提交

2021年1月3日

首先提交符合 QC 标准的

2021年4月5日

首次发布 (实际的)

2021年4月6日

研究记录更新

最后更新发布 (实际的)

2022年7月20日

上次提交的符合 QC 标准的更新

2022年7月16日

最后验证

2022年7月1日

更多信息

与本研究相关的术语

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

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.

ICRS的临床试验

3
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