Cardiovascular Rehabilitation: Insertion of Virtual Reality-based Therapy and Evaluation of Barriers
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiovascular Diseases
- Sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Blood pressure
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Mayara Moura Alves da Cruz
Principal Investigator
Universidade Estadual Paulista Júlio de Mesquita Filho
Eligibility Criteria
Inclusion Criteria
- •Clinical diagnosis of cardiovascular disease.
- •Clinical diagnosis of cardiovascular risk factors.
Exclusion Criteria
- •Presence exacerbated signs or symptoms.
- •Balance problems.
Outcomes
Primary Outcomes
Blood pressure
Time Frame: Change from baseline at 6 and 12 weeks
Measured using both systolic blood pressure and diastolic blood pressure
Respiratory rate
Time Frame: Change from baseline at 6 and 12 weeks
Measured using the number of respiratory incursions in one minute
Oxygen Saturation
Time Frame: Change from baseline at 6 and 12 weeks
Measured using an oximeter
Chronic autonomic response: linear indices
Time Frame: 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
Time Frame: Change from baseline at 6 and 12 weeks
Measured using an equipment validated for recording heart rate beat to beat
Perceived Exertion
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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)