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临床试验/NCT04833400
NCT04833400Unknown不适用

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

Taipei Medical University WanFang Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年1月25日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
relative VO2-peak (mL/kg/min)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

relative VO2-peak (mL/kg/min)

时间窗: 4 weeks

oxygen consumption (VO2- peak) is measured during a the cardiopulmonary exercise test with a ramped stationary biking.

次要结局

  • 6-min walk test(4 weeks)
  • absolute VO2-peak (mL/min)(4 weeks)
  • workload-peak (Watt)(4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yen-Nung Lin

Director of Physical Medicine and Rehabilitation

Taipei Medical University WanFang Hospital

研究点 (1)

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