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Virtual Reality Based-therapy Applied to Physical Therapy in Cardiology.

2019年8月2日 更新者:Ana Laura Ricci-Vitor、Universidade Estadual Paulista Júlio de Mesquita Filho
The aim of this study is to investigate engagement, motivation, and the barriers to adherence of virtual reality based therapy (VRBT) in patients with cardiac diseases and risk factors to the development of cardiac diseases. In addition, to investigate autonomic and hemodynamic responses of VRBT in comparison with conventional therapy (CT). To do this, patients with cardiac diseases or risk factors will be invited to perform CT or VRBT+CT. They will be submitted to an initial evaluation, and then will be random allocated to 12 weeks of intervention and to a final evaluation. The primary outcomes includes engagement, motivation, barriers and adherence in the 12 previous weeks using questionnaire, after 12 weeks of the intervention and after 12 weeks of the final intervention program. Hemodynamic and autonomic responses will be considered the secondary outcomes being evaluated before, during and after a session at the first, sixth and twelfth week.

研究概览

地位

完全的

干预/治疗

详细说明

Introduction: cardiovascular rehabilitation programs (CR) can promote several benefits in patients with cardiac diseases. However, there are problems related to the patient adherence in CR. Some of these problems can be caused to factors like motivation. Alternative therapies can improve motivation and increase adherence to CR. In this context, virtual reality based therapy (VRBT), have shown benefits in cardiac patients to pain relief, functional capacity and increasing physical activity levels, but there is no answer whether it can increase engagement and adherence to CR. In addition, it is important to investigate hemodynamic responses of VRBT. Objective: investigate engagement, motivation, and the barriers to adherence of VRBT in patients with cardiac diseases and risk factors to the development of cardiac diseases. In addition, to investigate autonomic and hemodynamic responses of VRBT in comparison with conventional therapy (CT). Methods: patients with cardiac diseases or risk factors will be invited to perform CT or VRBT+CT. They will be submitted to an initial evaluation, the intervention and to a final evaluation. The initial evaluation include eligibility investigation, and after they will be random allocated to the interventions. The interventions will be performed with a frequency of three times a week, for 12 weeks, and the intensity will be prescribed individually. The primary outcomes includes engagement, motivation, barriers and adherence in the 12 previous weeks according to a recall questionnaire, after 12 weeks of the intervention and after 12 weeks of the final intervention program. The engagement will be evaluated using the User Engagement Scale (modified). Motivation will be evaluated using the intrinsic motivation questionnaire. The barriers will be evaluated using the Barriers Scale of Cardiac Rehabilitation. Adherence will be evaluated using the presence in the patient's records. Hemodynamic responses will be evaluated before, during and after a session at the first, sixth and twelfth week using blood pressure, heart rate, respiratory rate, oxygen saturation and rating of perceived exertion. Autonomic responses will be evaluated using heart rate variability. Statistical analysis: the data analysis will be evaluated using the two way ANOVA with Bonferroni posttest with significance to p < 0.05.

研究类型

介入性

注册 (实际的)

68

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

    • São Paulo
      • Presidente Prudente、São Paulo、巴西、19060900
        • Laboratório de Fisiologia do Estresse

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

16年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Patients with cardiovascular diseases
  • Patients with risk factors to develop cardiovascular diseases

Exclusion Criteria:

- Patients who disagree to participate of any protocol interventions

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:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
有源比较器:Conventional therapy
Exercise-based cardiac rehabilitation
Both interventions uses exercises
实验性的:Virtual reality based therapy
Exercise-based virtual reality
Both interventions uses exercises

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
Engagement
大体时间:Change from baseline at 12 weeks
Measured using the Utrecht engagement scale modified There is 17 items scored from 1 to 7, according to the Likert Scale. Then, each item is summed and divided for the number of items. Higher values represent a better engagement.
Change from baseline at 12 weeks
Motivation
大体时间:Change from baseline at 12 weeks
Measured using the Intrinsic motivation inventory There is 18 items scored from 1 to 5, according to the Likert Scale. Then, each item is summed and divided for the number of items. Higher values represent a better motivation.
Change from baseline at 12 weeks
Barriers to Cardiac Rehabilitation
大体时间:Change from baseline at 12 weeks
Measured using Cardiac Rehabilitation Barriers Scale There is 21 items score from 1 to 5, according to the Likert Scale. Then, each item is summed and divided for the number of items. Higher values represent a worse outcome. In addition, there is four subscales: 1) Perceived need/health care factors, 2) Logistical factors, 3) Work/time conflicts, and 4) Comorbidities/functional status. The subscales are scored in the same way of the total, it means, from 1 to 5 and them dividing from the total number of the items included in the subscale.
Change from baseline at 12 weeks
Adherence to Cardiac Rehabilitation
大体时间:Change from baseline at 12 weeks
Measured using the number of cardiac rehabilitation sessions attended
Change from baseline at 12 weeks

次要结果测量

结果测量
措施说明
大体时间
Autonomic responses
大体时间:Up to 12 weeks
Measured using heart rate variability The heart rate variability will be measured through the following linear indices (SDNN: the standard deviation of normal-to-normal intervals, ms; rMSSD: the root mean square of successive difference between normal intervals,ms; RRtri: triangular index, based on RR intervals,ms; TINN: triangular interpolation of the normal to normal interval between consecutive heart beats, ms; LF: low frequency, nu; HF: high frequency and nonlinear indices,nu.). In addition the nonlinear indices will be measured (SD1: standard deviation of instant variability beat to beat; SD2: standard deviation of long-term interval between consecutive heart beats). In general higher values represent a better autonomic response.
Up to 12 weeks
Blood pressure
大体时间:Up to 12 weeks
Measured using both systolic blood pressure and diastolic blood pressure
Up to 12 weeks
Heart rate
大体时间:Up to 12 weeks
Measured using an equipment validated for recording heart rate beat to beat
Up to 12 weeks
Respiratory rate
大体时间:Up to 12 weeks
Measured using the number of respiratory incursions in one minute
Up to 12 weeks
Oxygen Saturation
大体时间:Up to 12 weeks
Measured using an oximeter
Up to 12 weeks
Perceived exertion
大体时间:Up to 12 weeks
Measured using Borg Scale. This scale varies from 6 to 20.
Up to 12 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。

调查人员

  • 首席研究员:Ana Laura Ricci-Vitor, PhD、Universidade Estadual Paulista Júlio de Mesquita Filho

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)

2017年12月19日

初级完成 (实际的)

2018年12月1日

研究完成 (实际的)

2019年6月3日

研究注册日期

首次提交

2017年11月6日

首先提交符合 QC 标准的

2017年12月13日

首次发布 (实际的)

2017年12月19日

研究记录更新

最后更新发布 (实际的)

2019年8月5日

上次提交的符合 QC 标准的更新

2019年8月2日

最后验证

2019年8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)?

IPD 计划说明

After published results,

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.

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