Clinical trial NCT03377582: Virtual Reality Based-therapy Applied to Physical Therapy in Cardiology.
Official title: Virtual Reality Based-therapy Applied to Physical Therapy in Cardiology.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Disease
Risk Factor, Cardiovascular
Keywords: 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
Lead sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho
Sponsor class: OTHER
First posted: 2017-12-19
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Engagement
timeFrame: Change from baseline at 12 weeks
measure: Motivation
timeFrame: Change from baseline at 12 weeks
measure: Barriers to Cardiac Rehabilitation
timeFrame: Change from baseline at 12 weeks
measure: Adherence to Cardiac Rehabilitation
timeFrame: Change from baseline at 12 weeks
Secondary outcomes:
measure: Autonomic responses
timeFrame: Up to 12 weeks
measure: Blood pressure
timeFrame: Up to 12 weeks
measure: Heart rate
timeFrame: Up to 12 weeks
measure: Respiratory rate
timeFrame: Up to 12 weeks
measure: Oxygen Saturation
timeFrame: Up to 12 weeks
measure: Perceived exertion
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Presidente Prudente
country: Brazil
facility: Laboratório de Fisiologia do Estresse
state: São Paulo
Study officials:
affiliation: Universidade Estadual Paulista Júlio de Mesquita Filho
name: Ana Laura Ricci-Vitor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.