Virtual Reality Based-therapy Applied to Physical Therapy in Cardiology.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Motivation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
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
- •Patients with cardiovascular diseases
- •Patients with risk factors to develop cardiovascular diseases
排除标准
- •Patients who disagree to participate of any protocol interventions
研究组 & 干预措施
Conventional therapy
Exercise-based cardiac rehabilitation
干预措施: Exercise (Other)
Virtual reality based therapy
Exercise-based virtual reality
干预措施: Exercise (Other)
结局指标
主要结局
Motivation
时间窗: 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.
Engagement
时间窗: 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.
Barriers to Cardiac Rehabilitation
时间窗: 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.
Adherence to Cardiac Rehabilitation
时间窗: Change from baseline at 12 weeks
Measured using the number of cardiac rehabilitation sessions attended
次要结局
- Blood pressure(Up to 12 weeks)
- Oxygen Saturation(Up to 12 weeks)
- Respiratory rate(Up to 12 weeks)
- Autonomic responses(Up to 12 weeks)
- Heart rate(Up to 12 weeks)
- Perceived exertion(Up to 12 weeks)
研究者
Ana Laura Ricci-Vitor
PhD
Universidade Estadual Paulista Júlio de Mesquita Filho
