Virtual Reality-based Therapy and Barriers in Cardiac Patients
- Conditions
- Cardiovascular Diseases
- Interventions
- Other: virtual reality-based therapy (VRBT)
- Registration Number
- NCT04336306
- Lead Sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Clinical diagnosis of cardiovascular disease.
- Clinical diagnosis of cardiovascular risk factors.
- Presence exacerbated signs or symptoms.
- Balance problems.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Evaluation of chronic hemodynamic and autonomic repercussions virtual reality-based therapy (VRBT) 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.
- Primary Outcome Measures
Name Time Method Blood pressure Change from baseline at 6 and 12 weeks Measured using both systolic blood pressure and diastolic blood pressure
Oxygen Saturation Change from baseline at 6 and 12 weeks Measured using an oximeter
Respiratory rate Change from baseline at 6 and 12 weeks Measured using the number of respiratory incursions in one minute
Chronic autonomic response: linear indices 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 Change from baseline at 6 and 12 weeks Measured using an equipment validated for recording heart rate beat to beat
Perceived Exertion 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 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 Outcome Measures
Name Time Method Perception of physiotherapists about the barriers and facilitators of the use of Virtual reality After 12 weeks 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.
Barriers identification in frequenters of Cardiovascular Rehabilitation. After 12 week Measured by a new questionnaire of barriers. This new questionnaire has 15 questions, which are divided into domains.
Perception of patients about Virtual reality After 12 weeks 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.
Trial Locations
- Locations (1)
Universidade Estadual Paulista Júlio de Mesquita Filho
🇧🇷Presidente Prudente, São Paulo, Brazil