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临床试验/NCT04336306
NCT04336306已完成不适用

Cardiovascular Rehabilitation: Insertion of Virtual Reality-based Therapy and Evaluation of Barriers

Universidade Estadual Paulista Júlio de Mesquita Filho2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Blood pressure

研究概览

简要总结

The aim of this study is to investigate the chronic hemodynamic and autonomic repercussions of the insertion of VRBT in CR. To qualitatively analyze the perception of patients and physiotherapists regarding the use of VRBT, as well as their association with CR, and through a new questionnaire that takes into account patients 'adherence, identifying which are the main barriers that influence patients' absences.

详细描述

Introduction

Despite the benefits that cardiovascular rehabilitation programs (CR) can promote, there are problems regarding adherence, which can be related to several factors, among them, motivation. Alternative therapies can reflect on motivation and promote increased adherence to CR. In this context, virtual reality-based therapy (VRBT) appears as an option. Additionally, chronic hemodynamic and autonomic repercussions of VRBT in relation to CV still need to be investigated. Objective: To evaluate the chronic hemodynamic and autonomic repercussions of the insertion of VRBT in CR. To qualitatively analyze the perception of patients and physiotherapists regarding the use of TRV, as well as their association with CR, and through a new questionnaire that takes into account patients 'adherence, identifying which are the main barriers that influence patients' absences. Methods: cardiac patients or individuals with factors that regularly participate in CR will participate in this study. Patients will be randomly allocated to CR + VRBT intervention or keeping the normal routine. Interventions will be carried out three times a week for 12 weeks. The primary outcome will be to assess chronic hemodynamic repercussions (blood pressure, heart rate, respiratory rate, oxygen saturation and perceived exertion using the Borg scale) and autonomic (linear and non-linear data). The secondary outcome consists of a qualitative assessment through a focus group with patients and a focus group with therapists, in addition, the new questionnaire developed to identify the influence of barriers on patients' adherence to CR will be applied.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Clinical diagnosis of cardiovascular disease.
  • Clinical diagnosis of cardiovascular risk factors.

排除标准

  • Presence exacerbated signs or symptoms.
  • Balance problems.

结局指标

主要结局

Blood pressure

时间窗: Change from baseline at 6 and 12 weeks

Measured using both systolic blood pressure and diastolic blood pressure

Respiratory rate

时间窗: Change from baseline at 6 and 12 weeks

Measured using the number of respiratory incursions in one minute

Oxygen Saturation

时间窗: Change from baseline at 6 and 12 weeks

Measured using an oximeter

Chronic autonomic response: linear indices

时间窗: Change from baseline at 6 and 12 weeks

Measured using heart rate variability : 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. In general higher values represent a better autonomic response.

Heart rate

时间窗: Change from baseline at 6 and 12 weeks

Measured using an equipment validated for recording heart rate beat to beat

Perceived Exertion

时间窗: Change from baseline at 6 and 12 weeks

Measured using Borg Scale, this scale varies from 6 to 20

Chronic autonomic response:no linear indices

时间窗: Change from baseline at 6 and 12 weeks

Measured using heart rate variability : Detrended Fluctuation Analysis, Recurrence Plot, Multiscalar Entropy, symbolic analysis.In general higher values represent a better autonomic response.

次要结局

  • Perception of physiotherapists about the barriers and facilitators of the use of Virtual reality(After 12 weeks)
  • Barriers identification in frequenters of Cardiovascular Rehabilitation.(After 12 week)
  • Perception of patients about Virtual reality(After 12 weeks)

研究者

发起方
Universidade Estadual Paulista Júlio de Mesquita Filho
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mayara Moura Alves da Cruz

Principal Investigator

Universidade Estadual Paulista Júlio de Mesquita Filho

研究点 (2)

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