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Virtual Reality-based Therapy and Barriers in Cardiac Patients

U

Universidade Estadual Paulista Júlio de Mesquita Filho

Status

Completed

Conditions

Cardiovascular Diseases

Treatments

Other: virtual reality-based therapy (VRBT)

Study type

Interventional

Funder types

Other

Identifiers

NCT04336306
29742920.9.0000.5402

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Presence exacerbated signs or symptoms.
  • Balance problems.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

60 participants in 1 patient group

Evaluation of chronic hemodynamic and autonomic repercussions
Experimental group
Description:
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.
Treatment:
Other: virtual reality-based therapy (VRBT)

Trial contacts and locations

1

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Central trial contact

Mayara MA da Cruz, Master

Data sourced from clinicaltrials.gov

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