跳至主要内容
临床试验/NCT05149235
NCT05149235已完成不适用

Effects of Infusion of Gaming Technology With Cardiac Rehabilitation on Autonomic Modulation of Heart: a Randomized Control Trial

Bahria University2 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2022年3月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
86
试验地点
2
主要终点
change in autonomic modulation of heart

研究概览

简要总结

Moderate to vigorous physical activity has been shown to be associated with autonomic regulation of the heart measured with heart rate variability. Cardiac autonomic modulation can be evaluated by heart rate variability. Activity promoting games can be an effective tool to aid rehabilitation in clinical settings. Combining gaming with the ergo-cycle can facilitate improving patients' activity time spent on the cycle.

详细描述

Physical activity is recognized as a central component of cardiac rehabilitation, improving control of cardiovascular risk factors, reducing the incidence of adverse events, leading to improvements in cardiovascular conditioning and prevention of thromboembolic events. Consequently, it provides greater physical independence and safety for hospital discharge. Coronary artery bypass grafting (CABG) surgery may lead to prolonged bed rest, and immobility, which can result in negative consequences, such as a decrease in functional capacity, decrease in muscle mass and muscle tone, postural hypotension, and changes in autonomic modulation of the heart rate. Cardiac autonomic modulation can be evaluated by heart rate variability (HRV), which involves simple noninvasive measurement of the oscillations in intervals between consecutive heartbeats.

Technology such as video games plays a complicated role in physical inactivity-much like a double-edged sword. To overcome this problem, the newly emerged active video games have been increasingly used to promote physical activity and health among various populations. Augmented reality games are unique because they integrate the physical and virtual worlds into a single interface using mobile devices applications. Investigators present a proof of concept of an endless running game called physio adventure which implements an activity recognition system that detects cycle rotation and its speed. The goal is to replace the traditional rehabilitation devices with innovative gaming technology with a more natural movement-based one, showing the potential of this kind of interaction to create innovative and immersive experiences while promoting physical activity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients submitted to elective cardiac surgery (valvular or coronary bypass surgery by sternotomy)
  • Both male and female
  • a score of 15 on the Glasgow Coma Scale
  • musculoskeletal, and cardiopulmonary conditions suitable for the accomplishment of the proposed activities
  • absence of neurological sequelae and/or neurodegenerative diseases

排除标准

  • Those who had difficulty understanding the activities involved in the study.
  • those with any motor or neurological impairment that would prevent them from using a cycle ergometer.
  • those who discontinued the protocol on the ward for return to the ICU
  • previous cardiac surgeries
  • hemodynamic instability that prevented protocol performance
  • breathing discomfort
  • invasive ventilatory support
  • oxygen saturation below 90% (even with complementary oxygen therapy)
  • coagulation disorders
  • infections in any of the systems
  • nonperformance of the whole protocol

结局指标

主要结局

change in autonomic modulation of heart

时间窗: heart rate variability will be recorded on day of admission, 1st post-operative day and 4th post operative day

autonomic modulation of heart will be assessed by measuring heart rate variability

次要结局

未报告次要终点

研究者

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

Seyyada Tahniat Ali

clinical instructor

Bahria University

研究点 (2)

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