Virtual Reality-based Therapy and Barriers in Cardiac Patients

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04336306
• Other study ID #: 29742920.9.0000.5402
• Status: Completed
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: October 23, 2022

Study information

• Verified date: July 2023
• Source: Universidade Estadual Paulista Júlio de Mesquita Filho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 23, 2022
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of cardiovascular disease.

• Clinical diagnosis of cardiovascular risk factors.

Exclusion Criteria:

• Presence exacerbated signs or symptoms.

• Balance problems.

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Other:
• virtual reality-based therapy (VRBT)
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.

Locations

Country	Name	City	State
Brazil	Universidade Estadual Paulista Júlio de Mesquita Filho	Presidente Prudente	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Estadual Paulista Júlio de Mesquita Filho

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

Alves da Cruz M, Laurino M, Christofaro D, Ghisi G, Vanderlei L. Long-term effects of virtual reality-based therapy in cardiovascular rehabilitation: A longitudinal study. Physiother Theory Pract. 2022 Dec 25:1-9. doi: 10.1080/09593985.2022.2160222. Onlin — View Citation

Alves da Cruz MM, Ricci-Vitor AL, Bonini Borges GL, Fernanda da Silva P, Ribeiro F, Marques Vanderlei LC. Acute Hemodynamic Effects of Virtual Reality-Based Therapy in Patients of Cardiovascular Rehabilitation: A Cluster Randomized Crossover Trial. Arch Phys Med Rehabil. 2020 Apr;101(4):642-649. doi: 10.1016/j.apmr.2019.12.006. Epub 2020 Jan 8. — View Citation

da Cruz MMA, Grigoletto I, Ricci-Vitor AL, da Silva JM, Franco MR, Vanderlei LCM. Perceptions and preferences of patients with cardiac conditions to the inclusion of virtual reality-based therapy with conventional cardiovascular rehabilitation: A qualitat — View Citation

da Cruz MMA, Ricci-Vitor AL, Borges GLB, da Silva PF, Turri-Silva N, Takahashi C, Grace SL, Vanderlei LCM. A Randomized, Controlled, Crossover Trial of Virtual Reality in Maintenance Cardiovascular Rehabilitation in a Low-Resource Setting: Impact on Adherence, Motivation, and Engagement. Phys Ther. 2021 May 4;101(5):pzab071. doi: 10.1093/ptj/pzab071. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Blood pressure	Measured using both systolic blood pressure and diastolic blood pressure	Change from baseline at 6 and 12 weeks
Primary	Heart rate	Measured using an equipment validated for recording heart rate beat to beat	Change from baseline at 6 and 12 weeks
Primary	Respiratory rate	Measured using the number of respiratory incursions in one minute	Change from baseline at 6 and 12 weeks
Primary	Oxygen Saturation	Measured using an oximeter	Change from baseline at 6 and 12 weeks
Primary	Perceived Exertion	Measured using Borg Scale, this scale varies from 6 to 20	Change from baseline at 6 and 12 weeks
Secondary	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
Secondary	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
Secondary	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