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Completed

NCT Number: NCT04336306

Virtual Reality-based Therapy and Barriers in Cardiac Patients

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.

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Key information

Conditions

Cardiovascular Diseases Behavior Health Behavior Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Estadual Paulista Júlio de Mesquita Filho

Presidente Prudente, São Paulo, 19060-900, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of cardiovascular disease.
  • Clinical diagnosis of cardiovascular risk factors.

Exclusion criteria

  • Presence exacerbated signs or symptoms.
  • Balance problems.

Treatment and study plan

virtual reality-based therapy (VRBT)

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. Blood pressure

    Time frame: Change from baseline at 6 and 12 weeks

    Measured using both systolic blood pressure and diastolic blood pressure

  4. Heart rate

    Time frame: Change from baseline at 6 and 12 weeks

    Measured using an equipment validated for recording heart rate beat to beat

  5. Respiratory rate

    Time frame: Change from baseline at 6 and 12 weeks

    Measured using the number of respiratory incursions in one minute

  6. Oxygen Saturation

    Time frame: Change from baseline at 6 and 12 weeks

    Measured using an oximeter

  7. Perceived Exertion

    Time frame: Change from baseline at 6 and 12 weeks

    Measured using Borg Scale, this scale varies from 6 to 20

Secondary outcomes

  1. Perception of physiotherapists about the barriers and facilitators of the use of Virtual reality

    Time frame: 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.

  2. Perception of patients about Virtual reality

    Time frame: 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.

  3. Barriers identification in frequenters of Cardiovascular Rehabilitation.

    Time frame: After 12 week

    Measured by a new questionnaire of barriers. This new questionnaire has 15 questions, which are divided into domains.

Sponsors and collaborators

Lead sponsor

Universidade Estadual Paulista Júlio de Mesquita Filho

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2022
First posted
Apr 7, 2020
Registry last updated
Jul 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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