Cardiovascular Rehabilitation: Insertion of Virtual Reality-based Therapy and Evaluation of Barriers
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
- 否
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
Mayara Moura Alves da Cruz
Principal Investigator
Universidade Estadual Paulista Júlio de Mesquita Filho
