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Virtual Reality Based-therapy Applied to Physical Therapy in Cardiology.

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ClinicalTrials.gov Identifier: NCT03377582
Recruitment Status : Recruiting
First Posted : December 19, 2017
Last Update Posted : December 19, 2017
Sponsor:
Information provided by (Responsible Party):
Ana Laura Ricci-Vitor, Universidade Estadual Paulista Júlio de Mesquita Filho

Brief Summary:
The aim of this study is to investigate engagement, motivation, and the barriers to adherence of virtual reality based therapy (VRBT) in patients with cardiac diseases and risk factors to the development of cardiac diseases. In addition, to investigate autonomic and hemodynamic responses of VRBT in comparison with conventional therapy (CT). To do this, patients with cardiac diseases or risk factors will be invited to perform CT or VRBT+CT. They will be submitted to an initial evaluation, and then will be random allocated to 12 weeks of intervention and to a final evaluation. The primary outcomes includes engagement, motivation, barriers and adherence in the 12 previous weeks using questionnaire, after 12 weeks of the intervention and after 12 weeks of the final intervention program. Hemodynamic and autonomic responses will be considered the secondary outcomes being evaluated before, during and after a session at the first, sixth and twelfth week.

Condition or disease Intervention/treatment Phase
Cardiac Disease Risk Factor, Cardiovascular Other: Exercise Not Applicable

Detailed Description:
Introduction: cardiovascular rehabilitation programs (CR) can promote several benefits in patients with cardiac diseases. However, there are problems related to the patient adherence in CR. Some of these problems can be caused to factors like motivation. Alternative therapies can improve motivation and increase adherence to CR. In this context, virtual reality based therapy (VRBT), have shown benefits in cardiac patients to pain relief, functional capacity and increasing physical activity levels, but there is no answer whether it can increase engagement and adherence to CR. In addition, it is important to investigate hemodynamic responses of VRBT. Objective: investigate engagement, motivation, and the barriers to adherence of VRBT in patients with cardiac diseases and risk factors to the development of cardiac diseases. In addition, to investigate autonomic and hemodynamic responses of VRBT in comparison with conventional therapy (CT). Methods: patients with cardiac diseases or risk factors will be invited to perform CT or VRBT+CT. They will be submitted to an initial evaluation, the intervention and to a final evaluation. The initial evaluation include eligibility investigation, and after they will be random allocated to the interventions. The interventions will be performed with a frequency of three times a week, for 12 weeks, and the intensity will be prescribed individually. The primary outcomes includes engagement, motivation, barriers and adherence in the 12 previous weeks according to a recall questionnaire, after 12 weeks of the intervention and after 12 weeks of the final intervention program. The engagement will be evaluated using the User Engagement Scale (modified). Motivation will be evaluated using the intrinsic motivation questionnaire. The barriers will be evaluated using the Barriers Scale of Cardiac Rehabilitation. Adherence will be evaluated using the presence in the patient's records. Hemodynamic responses will be evaluated before, during and after a session at the first, sixth and twelfth week using blood pressure, heart rate, respiratory rate, oxygen saturation and rating of perceived exertion. Autonomic responses will be evaluated using heart rate variability. Statistical analysis: the data analysis will be evaluated using the two way ANOVA with Bonferroni posttest with significance to p < 0.05.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Virtual Reality Based-therapy Applied to Physical Therapy in Cardiology.
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : June 30, 2019

Arm Intervention/treatment
Active Comparator: Conventional therapy
Exercise-based cardiac rehabilitation
Other: Exercise
Both interventions uses exercises

Experimental: Virtual reality based therapy
Exercise-based virtual reality
Other: Exercise
Both interventions uses exercises




Primary Outcome Measures :
  1. Engagement [ Time Frame: Change from baseline at 12 weeks ]
    Measured using the Utrecht engagement scale modified There is 17 items scored from 1 to 7, according to the Likert Scale. Then, each item is summed and divided for the number of items. Higher values represent a better engagement.

  2. Motivation [ Time Frame: Change from baseline at 12 weeks ]
    Measured using the Intrinsic motivation inventory There is 18 items scored from 1 to 5, according to the Likert Scale. Then, each item is summed and divided for the number of items. Higher values represent a better motivation.

  3. Barriers to Cardiac Rehabilitation [ Time Frame: Change from baseline at 12 weeks ]
    Measured using Cardiac Rehabilitation Barriers Scale There is 21 items score from 1 to 5, according to the Likert Scale. Then, each item is summed and divided for the number of items. Higher values represent a worse outcome. In addition, there is four subscales: 1) Perceived need/health care factors, 2) Logistical factors, 3) Work/time conflicts, and 4) Comorbidities/functional status. The subscales are scored in the same way of the total, it means, from 1 to 5 and them dividing from the total number of the items included in the subscale.

  4. Adherence to Cardiac Rehabilitation [ Time Frame: Change from baseline at 12 weeks ]
    Measured using the number of cardiac rehabilitation sessions attended


Secondary Outcome Measures :
  1. Autonomic responses [ Time Frame: Up to 12 weeks ]
    Measured using heart rate variability The heart rate variability will be measured through the following linear indices (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 and nonlinear indices,nu.). In addition the nonlinear indices will be measured (SD1: standard deviation of instant variability beat to beat; SD2: standard deviation of long-term interval between consecutive heart beats). In general higher values represent a better autonomic response.

  2. Blood pressure [ Time Frame: Up to 12 weeks ]
    Measured using both systolic blood pressure and diastolic blood pressure

  3. Heart rate [ Time Frame: Up to 12 weeks ]
    Measured using an equipment validated for recording heart rate beat to beat

  4. Respiratory rate [ Time Frame: Up to 12 weeks ]
    Measured using the number of respiratory incursions in one minute

  5. Oxygen Saturation [ Time Frame: Up to 12 weeks ]
    Measured using an oximeter

  6. Perceived exertion [ Time Frame: Up to 12 weeks ]
    Measured using Borg Scale. This scale varies from 6 to 20.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with cardiovascular diseases
  • Patients with risk factors to develop cardiovascular diseases

Exclusion Criteria:

- Patients who disagree to participate of any protocol interventions


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03377582


Contacts
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Contact: Ana Laura Ricci-Vitor, PhD +55 18 981121268 analaura.ricci@yahoo.com
Contact: Luiz Carlos M Vanderlei, PhD +55 18 32295819 lcmvanderlei@fct.unesp.br

Locations
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Brazil
Laboratório de Fisiologia do Estresse Recruiting
Presidente Prudente, São Paulo, Brazil, 19060900
Contact: Ana Laura Ricci-Vitor, PhD    +55 18 32295819    analaura.ricci@yahoo.com   
Contact: Luiz Carlos M Vanderlei, PhD    +55 18 32295819    lcmvanderlei@fct.unesp.br   
Sponsors and Collaborators
Universidade Estadual Paulista Júlio de Mesquita Filho
Investigators
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Principal Investigator: Ana Laura Ricci-Vitor, PhD Universidade Estadual Paulista Júlio de Mesquita Filho

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Responsible Party: Ana Laura Ricci-Vitor, PhD, Universidade Estadual Paulista Júlio de Mesquita Filho
ClinicalTrials.gov Identifier: NCT03377582     History of Changes
Other Study ID Numbers: NCT400579/2017-0
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: After published results,

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ana Laura Ricci-Vitor, Universidade Estadual Paulista Júlio de Mesquita Filho:
cardiovascular diseases
cardiac rehabilitation
sympathetic nervous system
heart rate
blood pressure
clinical trial
virtual reality exposure therapy
barriers to cardiac rehabilitation
motivation
adherence patient
engagement
perceived exertion
oxygen saturation

Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases