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Cardiovascular DiseasesNCT04336306

Virtual Reality-based Therapy and Barriers in Cardiac Patients

A study testing virtual reality-based therapy (VRBT) in people with Cardiovascular Diseases, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiovascular Diseases
What is being tested?
virtual reality-based therapy (VRBT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteBrazil
Study dates
1 Apr 2020to 23 Oct 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Presence exacerbated signs or symptoms.
  • Balance problems.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Universidade Estadual Paulista Júlio de Mesquita Filho

    Presidente Prudente, São Paulo, 19060-900

Other trials in Brazil

About this study

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

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.

Read the 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.

Being tested
virtual reality-based therapy (VRBT)
Keywords
sympathetic nervous system, heart rate, blood pressure, virtual reality exposure therapy, barriers to cardiac rehabilitation, motivation, adherence patient, engagement, perceived exertion, oxygen saturation
Medical subject headings
Cardiovascular Diseases, Patient Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT04336306
Study groupRoleWhat they receive
Evaluation of chronic hemodynamic and autonomic repercussionsExperimentalParticipants 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.
Receives: Other: virtual reality-based therapy (VRBT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Change from baseline at 6 and 12 weeks

  2. 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.

    Measured: Change from baseline at 6 and 12 weeks

  3. Blood pressure

    Measured using both systolic blood pressure and diastolic blood pressure

    Measured: Change from baseline at 6 and 12 weeks

  4. Heart rate

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

    Measured: Change from baseline at 6 and 12 weeks

  5. Respiratory rate

    Measured using the number of respiratory incursions in one minute

    Measured: Change from baseline at 6 and 12 weeks

  6. Oxygen Saturation

    Measured using an oximeter

    Measured: Change from baseline at 6 and 12 weeks

  7. Perceived Exertion

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

    Measured: Change from baseline at 6 and 12 weeks

Secondary outcomes (3)

  1. 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.

    Measured: After 12 weeks

  2. 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.

    Measured: After 12 weeks

  3. 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.

    Measured: After 12 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2020
  2. Study start1 Apr 2020
  3. Primary completion30 Jun 2020
  4. Study completion23 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04336306
Sponsor's protocol ID
29742920.9.0000.5402
Status last verified
Jul 2023
First submitted
31 Mar 2020
Last updated
21 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31926142

  • 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.

    PubMed 33625515

  • 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 qualitative study. Braz J Phys Ther. 2022 May-Jun;26(3):100419. doi: 10.1016/j.bjpt.2022.100419. Epub 2022 May 18.

    PubMed 35636061

  • 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. 2024 Apr;40(4):727-735. doi: 10.1080/09593985.2022.2160222. Epub 2022 Dec 25.

    PubMed 36567613

Questions about this trial

What is this clinical trial studying?

A study testing virtual reality-based therapy (VRBT) in people with Cardiovascular Diseases, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Chronic autonomic response: linear indices (time frame: Change from baseline at 6 and 12 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04336306, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2023.

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