NCT04336306

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Apr 2020

Typical duration for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 7, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2022

Completed
Last Updated

July 21, 2023

Status Verified

July 1, 2023

Enrollment Period

3 months

First QC Date

March 31, 2020

Last Update Submit

July 19, 2023

Conditions

Cardiovascular Diseases

Keywords

sympathetic nervous systemheart rateblood pressurevirtual reality exposure therapybarriers to cardiac rehabilitationmotivationadherence patientengagementperceived exertionoxygen saturation

Outcome Measures

Primary Outcomes (7)

  • 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

  • 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

  • Blood pressure

    Measured using both systolic blood pressure and diastolic blood pressure

    Change from baseline at 6 and 12 weeks

  • Heart rate

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

    Change from baseline at 6 and 12 weeks

  • Respiratory rate

    Measured using the number of respiratory incursions in one minute

    Change from baseline at 6 and 12 weeks

  • Oxygen Saturation

    Measured using an oximeter

    Change from baseline at 6 and 12 weeks

  • Perceived Exertion

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

    Change from baseline at 6 and 12 weeks

Secondary Outcomes (3)

  • Perception of physiotherapists about the barriers and facilitators of the use of Virtual reality

    After 12 weeks

  • Perception of patients about Virtual reality

    After 12 weeks

  • Barriers identification in frequenters of Cardiovascular Rehabilitation.

    After 12 week

Study Arms (1)

Evaluation of chronic hemodynamic and autonomic repercussions

EXPERIMENTAL

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.

Other: virtual reality-based therapy (VRBT)

Interventions

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.

Evaluation of chronic hemodynamic and autonomic repercussions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Presence exacerbated signs or symptoms.
  • Balance problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Estadual Paulista Júlio de Mesquita Filho

Presidente Prudente, São Paulo, 19060-900, Brazil

Location

Related Publications (4)

  • 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.

    PMID: 31926142BACKGROUND

  • 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.

    PMID: 33625515BACKGROUND

  • 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.

    PMID: 35636061RESULT

  • 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.

    PMID: 36567613RESULT

MeSH Terms

Conditions

Cardiovascular DiseasesPatient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Mayara MA da Cruz, Master

    Universidade Estadual Paulista Júlio de Mesquita Filho

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 31, 2020

First Posted

April 7, 2020

Study Start

April 1, 2020

Primary Completion

June 30, 2020

Study Completion

October 23, 2022

Last Updated

July 21, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)