Virtual Reality-based Therapy and Barriers in Cardiac Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Other: virtual reality-based therapy (VRBT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of cardiovascular disease. Clinical diagnosis of cardiovascular risk factors. Exclusion Criteria: Presence exacerbated signs or symptoms. Balance problems.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Evaluation of chronic hemodynamic and autonomic repercussions<br>Participants in a cardiovascular rehabilitation program will be randomly allocated to CR + VRBT interventions. This group will hold 3 weekly sessions (one for VRBT and two for CR) for 12 weeks. In the first, sixth and last week, chronic hemodynamic data and autonomic data will be evaluated.Furthermore,at the end of 12 weeks, a focus group with therapists and a focus group with patients will be held to identify qualitative aspects in relation to the insertion of VRBT. And in all eligible patients of CR wiil be applied the Questionnaire of barriers identification in frequenters of Cardiovascular Rehabilitation. | Other: virtual reality-based therapy (VRBT)<br>* The warm-up was performed using the Just Dance 2015 game, in a sequence previously defined in a pilot study, aiming to increase HR progressively. A multimedia projector (Epson Power Life, H309A, China) connected to a console (Xbox One KinectTM, Microsoft, Redmond, WA) was used to project the game onto a white wall.The conditioning phase was performed using the Shape Up exercise game, in which patients perform exercises following a virtual therapist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic autonomic response: linear indices | 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. | Change from baseline at 6 and 12 weeks | 
| Chronic autonomic response:no linear indices | Measured using heart rate variability : Detrended Fluctuation Analysis, Recurrence Plot, Multiscalar Entropy, symbolic analysis.In general higher values represent a better autonomic response. | Change from baseline at 6 and 12 weeks | 
| Blood pressure | Measured using both systolic blood pressure and diastolic blood pressure | Change from baseline at 6 and 12 weeks | 
| Heart rate | Measured using an equipment validated for recording heart rate beat to beat | Change from baseline at 6 and 12 weeks | 
| Respiratory rate | Measured using the number of respiratory incursions in one minute | Change from baseline at 6 and 12 weeks | 
| Oxygen Saturation | Measured using an oximeter | Change from baseline at 6 and 12 weeks | 
| Perceived Exertion | Measured using Borg Scale, this scale varies from 6 to 20 | Change from baseline at 6 and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perception of physiotherapists about the barriers and facilitators of the use of Virtual reality | Measured by a focal groups with 5 therapist, that used virtual reality. Focal groups will be conducted by a researcher using a previously developed script, with open questions. The moderator will be a PhD student, with previous experience in physical training and qualitative research. A second researcher will be present at the focal groups to detail notes of the participant's answers. | After 12 weeks | 
| Perception of patients about Virtual reality | Measured by a 3 focal groups with 4 to 8 patients each, that performed virtual reality. Focal groups will be conducted by a researcher using a previously developed script, with open questions. The moderator will be a PhD student, with previous experience in physical training and qualitative research. A second researcher will be present at the focal groups to detail notes of the participant's answers. | After 12 weeks | 
| Barriers identification in frequenters of Cardiovascular Rehabilitation. | Measured by a new questionnaire of barriers. This new questionnaire has 15 questions, which are divided into domains. | After 12 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sympathetic nervous system, heart rate, blood pressure, virtual reality exposure therapy, barriers to cardiac rehabilitation, motivation, adherence patient, engagement, perceived exertion, oxygen saturation