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
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Disease Risk Factor, Cardiovascular||Other: Exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||68 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
Active Comparator: Conventional therapy
Exercise-based cardiac rehabilitation
Both interventions uses exercises
Experimental: Virtual reality based therapy
Exercise-based virtual reality
Both interventions uses exercises
- 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.
- 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.
- 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.
- Adherence to Cardiac Rehabilitation [ Time Frame: Change from baseline at 12 weeks ]Measured using the number of cardiac rehabilitation sessions attended
- 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.
- Blood pressure [ Time Frame: Up to 12 weeks ]Measured using both systolic blood pressure and diastolic blood pressure
- Heart rate [ Time Frame: Up to 12 weeks ]Measured using an equipment validated for recording heart rate beat to beat
- Respiratory rate [ Time Frame: Up to 12 weeks ]Measured using the number of respiratory incursions in one minute
- Oxygen Saturation [ Time Frame: Up to 12 weeks ]Measured using an oximeter
- Perceived exertion [ Time Frame: Up to 12 weeks ]Measured using Borg Scale. This scale varies from 6 to 20.
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
|Contact: Ana Laura Ricci-Vitor, PhD||+55 18 firstname.lastname@example.org|
|Contact: Luiz Carlos M Vanderlei, PhD||+55 18 email@example.com|
|Laboratório de Fisiologia do Estresse||Recruiting|
|Presidente Prudente, São Paulo, Brazil, 19060900|
|Contact: Ana Laura Ricci-Vitor, PhD +55 18 32295819 firstname.lastname@example.org|
|Contact: Luiz Carlos M Vanderlei, PhD +55 18 32295819 email@example.com|
|Principal Investigator:||Ana Laura Ricci-Vitor, PhD||Universidade Estadual Paulista Júlio de Mesquita Filho|