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

Sponsor

Universidade Estadual Paulista Júlio de Mesquita Filho (Other)

Overall Status

Completed

CT.gov ID

NCT03377582

Collaborator

(none)

Enrollment

Location

Arms

17.4

Actual Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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.

Study Design

Study Type:

Interventional

Actual 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 :

Dec 19, 2017

Actual Primary Completion Date :

Dec 1, 2018

Actual Study Completion Date :

Jun 3, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Engagement [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.
Motivation [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.
Barriers to Cardiac Rehabilitation [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.
Adherence to Cardiac Rehabilitation [Change from baseline at 12 weeks]
Measured using the number of cardiac rehabilitation sessions attended

Secondary Outcome Measures

Autonomic responses [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.
Blood pressure [Up to 12 weeks]
Measured using both systolic blood pressure and diastolic blood pressure
Heart rate [Up to 12 weeks]
Measured using an equipment validated for recording heart rate beat to beat
Respiratory rate [Up to 12 weeks]
Measured using the number of respiratory incursions in one minute
Oxygen Saturation [Up to 12 weeks]
Measured using an oximeter
Perceived exertion [Up to 12 weeks]
Measured using Borg Scale. This scale varies from 6 to 20.