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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03377582
Virtual Reality Based-therapy Applied to Physical Therapy in Cardiology.
2 de agosto de 2019 actualizado por: Ana Laura Ricci-Vitor, Universidade Estadual Paulista Júlio de Mesquita Filho
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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
68
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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-
São Paulo
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Presidente Prudente, São Paulo, Brasil, 19060900
- Laboratório de Fisiologia do Estresse
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
16 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: Conventional therapy
Exercise-based cardiac rehabilitation
|
Both interventions uses exercises
|
Experimental: Virtual reality based therapy
Exercise-based virtual reality
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Both interventions uses exercises
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Engagement
Periodo de tiempo: 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.
|
Change from baseline at 12 weeks
|
Motivation
Periodo de tiempo: 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.
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Change from baseline at 12 weeks
|
Barriers to Cardiac Rehabilitation
Periodo de tiempo: Change from baseline at 12 weeks
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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.
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Change from baseline at 12 weeks
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Adherence to Cardiac Rehabilitation
Periodo de tiempo: Change from baseline at 12 weeks
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Measured using the number of cardiac rehabilitation sessions attended
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Change from baseline at 12 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Autonomic responses
Periodo de tiempo: 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.
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Up to 12 weeks
|
Blood pressure
Periodo de tiempo: Up to 12 weeks
|
Measured using both systolic blood pressure and diastolic blood pressure
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Up to 12 weeks
|
Heart rate
Periodo de tiempo: Up to 12 weeks
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Measured using an equipment validated for recording heart rate beat to beat
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Up to 12 weeks
|
Respiratory rate
Periodo de tiempo: Up to 12 weeks
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Measured using the number of respiratory incursions in one minute
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Up to 12 weeks
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Oxygen Saturation
Periodo de tiempo: Up to 12 weeks
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Measured using an oximeter
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Up to 12 weeks
|
Perceived exertion
Periodo de tiempo: Up to 12 weeks
|
Measured using Borg Scale.
This scale varies from 6 to 20.
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Up to 12 weeks
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Investigadores
- Investigador principal: Ana Laura Ricci-Vitor, PhD, Universidade Estadual Paulista Júlio de Mesquita Filho
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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). pii: pzab071. doi: 10.1093/ptj/pzab071.
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
19 de diciembre de 2017
Finalización primaria (Actual)
1 de diciembre de 2018
Finalización del estudio (Actual)
3 de junio de 2019
Fechas de registro del estudio
Enviado por primera vez
6 de noviembre de 2017
Primero enviado que cumplió con los criterios de control de calidad
13 de diciembre de 2017
Publicado por primera vez (Actual)
19 de diciembre de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
5 de agosto de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
2 de agosto de 2019
Última verificación
1 de agosto de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NCT400579/2017-0
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
No
Descripción del plan IPD
After published results,
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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